Chronic Idiopathic Urticaria
Conditions
Keywords
Chronic idiopathic urticaria, CIU, Xolair, IGE025, FcεRI, IgE
Brief summary
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.
Interventions
Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamines at Baseline
Exclusion criteria
* Clearly defined underlying etiology for chronic urticarias other than CIU (main manifestation being physical urticaria). This includes the following urticarias: Acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure or contact, as well as the following diseases as these diseases may have symptoms of urticaria or angioedema: Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer. * Previous treatment with omalizumab. * A history or presence of atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | Baseline through Day 85 post-treatment | Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2 |
| Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | Baseline through Day 85 post-treatment | Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Baseline to Day 85 | The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2 |
| Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Baseline through Day 85 | — |
| Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Baseline through Day 85 | Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength. |
| Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Baseline through Day 85 | Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength. |
| Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Baseline | The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2 |
| Serum Levels of Omalizumab | Baseline through Day 85 | Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks |
| Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Baseline through Day 85 | — |
| Mean (SD) Serum Total IgE % Change From Baseline by Visit | Baseline through Day 85 | — |
| Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Baseline through Day 85 | Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. |
| Mean (SD) Serum Free IgE % Change From Baseline by Visit | Baseline through Day 85 | — |
| Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Baseline through Day 140 | — |
| Change From Baseline in Urticaria Activity Score (UAS7) | Baseline, Day 85 | Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement. |
| Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Baseline, Day 85 | The investigator or the person he or she designated and the patient provided scoring of the patient's global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient's condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe |
| Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment | Day 29 to Day 85 | — |
| Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment | Baseline through Day 85 | The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. |
| Skindex-29 by Treatment | Baseline and Day 85 | The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients' quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe. |
| Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment | Baseline and Day 85 | The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity. |
| Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Baseline through Day 85 | — |
| Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Baseline through Day 85 | Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IGE025 IGE025 administered subcutaneously every 4 weeks at the study center | 20 |
| Placebo to IGE025 Placebo administered subcutaneously every 4 weeks at the study center. | 10 |
| Healthy Volunteers Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects | 10 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | administrative problems | 0 | 2 | 0 |
| Overall Study | Adverse Event | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | IGE025 | Placebo to IGE025 | Healthy Volunteers | Total |
|---|---|---|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 11.02 | 41.1 years STANDARD_DEVIATION 7.96 | 36.4 years STANDARD_DEVIATION 9.74 | 38.7 years STANDARD_DEVIATION 10.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 10 Participants | 10 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 8 Participants | 10 Participants | 36 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 20 | 6 / 10 |
| serious Total, serious adverse events | 0 / 20 | 2 / 10 |
Outcome results
Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Time frame: Baseline through Day 85 post-treatment
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skin cells: dermis lesional D1 (n=19,8) | 18.14 FcεRI positive skin cells | Standard Deviation 7.08 |
| IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skin cells: dermis lesional d85 (n=10,7) | 13.40 FcεRI positive skin cells | Standard Deviation 5.88 |
| IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skin cells:dermis lesional Chge(n=10,6) | -5.42 FcεRI positive skin cells | Standard Deviation 7.42 |
| IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skincells:dermis nonlesional D1(n=19,10) | 18.91 FcεRI positive skin cells | Standard Deviation 9.42 |
| IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skincells:dermis nonlesional D85(n=18,8) | 14.72 FcεRI positive skin cells | Standard Deviation 7.56 |
| IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skincells:dermis nonlesional Chg(n=17,8) | -5.40 FcεRI positive skin cells | Standard Deviation 9.06 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skincells:dermis nonlesional D85(n=18,8) | 20.81 FcεRI positive skin cells | Standard Deviation 7.3 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skin cells: dermis lesional D1 (n=19,8) | 15.17 FcεRI positive skin cells | Standard Deviation 3.11 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skincells:dermis nonlesional D1(n=19,10) | 20.48 FcεRI positive skin cells | Standard Deviation 5.54 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skin cells: dermis lesional d85 (n=10,7) | 20.19 FcεRI positive skin cells | Standard Deviation 8.76 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skincells:dermis nonlesional Chg(n=17,8) | -0.07 FcεRI positive skin cells | Standard Deviation 9.33 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | FcεRI +ve skin cells:dermis lesional Chge(n=10,6) | 3.69 FcεRI positive skin cells | Standard Deviation 10.58 |
Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin
Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Time frame: Baseline through Day 85 post-treatment
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells, lesional D1 (n=19,8) | 12.93 IgE positive skin cells | Standard Deviation 8.61 |
| IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells, lesional D85 (n=10,7) | 6.73 IgE positive skin cells | Standard Deviation 7.9 |
| IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells, lesional chg(n=10.6) | -5.69 IgE positive skin cells | Standard Deviation 10.96 |
| IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells,non-lesional D1 (n=19,10) | 13.82 IgE positive skin cells | Standard Deviation 10.21 |
| IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells,non-lesional D85 (n=18,8) | 9.80 IgE positive skin cells | Standard Deviation 11.66 |
| IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells,non-lesional Chng (n=17,8) | -4.87 IgE positive skin cells | Standard Deviation 9.83 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells,non-lesional D85 (n=18,8) | 18.30 IgE positive skin cells | Standard Deviation 7.51 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells, lesional D1 (n=19,8) | 15.23 IgE positive skin cells | Standard Deviation 15.71 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells,non-lesional D1 (n=19,10) | 16.59 IgE positive skin cells | Standard Deviation 9.35 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells, lesional D85 (n=10,7) | 12.47 IgE positive skin cells | Standard Deviation 6.54 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells,non-lesional Chng (n=17,8) | -0.84 IgE positive skin cells | Standard Deviation 6.18 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin | IgE positive cells, lesional chg(n=10.6) | -3.95 IgE positive skin cells | Standard Deviation 20.76 |
Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment
The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Time frame: Baseline through Day 85
Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGE025 | Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment | -10.19 Score | Standard Deviation 8.159 |
| Placebo IGE025 | Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment | -3.13 Score | Standard Deviation 7.18 |
Change From Baseline in Urticaria Activity Score (UAS7)
Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.
Time frame: Baseline, Day 85
Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data. If the Week 12 value was missing, it was imputed as the last available UAS7 value (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGE025 | Change From Baseline in Urticaria Activity Score (UAS7) | -23.1 units on a scale | Standard Deviation 12.94 |
| Placebo IGE025 | Change From Baseline in Urticaria Activity Score (UAS7) | -8.1 units on a scale | Standard Deviation 14.45 |
Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment
The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.
Time frame: Baseline and Day 85
Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment | Baseline (n=16,8) | 53.71 score | Standard Deviation 19.881 |
| IGE025 | Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment | Day 85 (n=17,8) | 14.51 score | Standard Deviation 22.319 |
| Placebo IGE025 | Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment | Baseline (n=16,8) | 59.24 score | Standard Deviation 15.35 |
| Placebo IGE025 | Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment | Day 85 (n=17,8) | 53.53 score | Standard Deviation 29.817 |
Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set
The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Time frame: Baseline
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Cd 3 Dermis (n=10,29) | 10.1600 # positive cells | Standard Deviation 9.00311 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Giemsa Epidermis (n=10,29) | 0.0000 # positive cells | Standard Deviation 0 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 8 Epidermis (n=10,29) | 0.0600 # positive cells | Standard Deviation 0.13499 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Giemsa Dermis (n=10,29) | 4.8000 # positive cells | Standard Deviation 5.62929 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD11c All skin layers (n=20,58) | 7.9000 # positive cells | Standard Deviation 9.45983 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Giemsa All Skin Layers (n=20,58) | 2.4000 # positive cells | Standard Deviation 4.59061 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 8 Dermis (n=10,29) | 5.9083 # positive cells | Standard Deviation 4.07998 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Haematoxylin + Eosin Epidermis (n=10,29) | 0.0000 # positive cells | Standard Deviation 0 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 3 All Skin Layers (n=20,58) | 5.1600 # positive cells | Standard Deviation 8.04634 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Haematoxylin + Eosin Dermis (n=10,29) | 0.0000 # positive cells | Standard Deviation 0 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 8 All Skin Layers (n=20,58) | 2.9842 # positive cells | Standard Deviation 4.11029 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Haematoxylin + Eosin All Skin Layers (n=20,58) | 0.0000 # positive cells | Standard Deviation 0 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD11c Dermis (n=10,29) | 14.6400 # positive cells | Standard Deviation 9.31083 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE Epidermis (n=10,29) | 0.0800 # positive cells | Standard Deviation 0.13984 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 117 Epidermis (n=10,29) | 10.1600 # positive cells | Standard Deviation 3.80386 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE Dermis (n=10,29) | 8.7600 # positive cells | Standard Deviation 5.92231 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 4 Epidermis (n=10,29) | 1.0250 # positive cells | Standard Deviation 1.75804 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE All Skin layers (n=20,58) | 4.4200 # positive cells | Standard Deviation 6.03739 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 117 Dermis (n=10,29) | 8.2200 # positive cells | Standard Deviation 2.44849 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + CD 11c Epidermis (n=10,28) | 0.0000 # positive cells | Standard Deviation 0 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 3 Epidermis (n=10,29) | 0.1600 # positive cells | Standard Deviation 0.26331 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + CD 11c Dermis (n=10,29) | 0.9150 # positive cells | Standard Deviation 1.29401 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 117 All Skin Layers (n=20,58) | 9.1900 # positive cells | Standard Deviation 3.26865 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE+CD 11c All Layers (n=20,57) | 0.4575 # positive cells | Standard Deviation 1.00672 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 4 Dermis (n=10,29) | 15.7750 # positive cells | Standard Deviation 10.06565 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + Tryptase Epidermis (n=10,28) | 0.0000 # positive cells | Standard Deviation 0 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Fc epsilon receptor I Epidermis (n=10,29) | 4.9800 # positive cells | Standard Deviation 2.02309 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + Tryptase Dermis (n=10,29) | 1.3000 # positive cells | Standard Deviation 1.01215 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD11c Epidermis ( n= 10,29) | 1.1600 # positive cells | Standard Deviation 1.13058 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + Tryptase All Skin Layers (n=20,57) | 0.6500 # positive cells | Standard Deviation 0.96437 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Fc epsilon receptor I Dermis (n=10,29) | 14.2000 # positive cells | Standard Deviation 6.76133 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Tryptase Epidermis (n=10,29) | 0.0000 # positive cells | Standard Deviation 0 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 4 All Skin Layers (n=20,58) | 8.4000 # positive cells | Standard Deviation 10.33004 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Tryptase Dermis (n=10,29) | 6.6400 # positive cells | Standard Deviation 3.53371 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Tryptase All Skin Layers (n=20,58) | 3.3200 # positive cells | Standard Deviation 4.18539 |
| IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Fc epsilon receptor I All Skin Layers (n=20,58) | 9.5900 # positive cells | Standard Deviation 6.77968 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Tryptase All Skin Layers (n=20,58) | 3.3871 # positive cells | Standard Deviation 4.26704 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD11c Epidermis ( n= 10,29) | 1.1241 # positive cells | Standard Deviation 0.92944 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD11c Dermis (n=10,29) | 19.6207 # positive cells | Standard Deviation 9.4226 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD11c All skin layers (n=20,58) | 10.3724 # positive cells | Standard Deviation 11.44855 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 3 Epidermis (n=10,29) | 0.4759 # positive cells | Standard Deviation 0.82046 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Cd 3 Dermis (n=10,29) | 10.8276 # positive cells | Standard Deviation 6.11385 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 3 All Skin Layers (n=20,58) | 5.6517 # positive cells | Standard Deviation 6.77879 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 4 Epidermis (n=10,29) | 1.0207 # positive cells | Standard Deviation 1.26297 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 4 Dermis (n=10,29) | 17.7000 # positive cells | Standard Deviation 9.72481 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 4 All Skin Layers (n=20,58) | 9.3603 # positive cells | Standard Deviation 10.86324 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 8 Epidermis (n=10,29) | 0.2138 # positive cells | Standard Deviation 0.34197 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 8 Dermis (n=10,29) | 6.0322 # positive cells | Standard Deviation 3.43255 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 8 All Skin Layers (n=20,58) | 3.1230 # positive cells | Standard Deviation 3.80226 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 117 Epidermis (n=10,29) | 9.9931 # positive cells | Standard Deviation 4.85502 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 117 Dermis (n=10,29) | 10.4241 # positive cells | Standard Deviation 5.56025 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | CD 117 All Skin Layers (n=20,58) | 10.2086 # positive cells | Standard Deviation 5.17814 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Fc epsilon receptor I Epidermis (n=10,29) | 6.0776 # positive cells | Standard Deviation 3.12906 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Fc epsilon receptor I Dermis (n=10,29) | 19.4500 # positive cells | Standard Deviation 8.21582 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Fc epsilon receptor I All Skin Layers (n=20,58) | 12.7638 # positive cells | Standard Deviation 9.13548 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Giemsa Epidermis (n=10,29) | 0.0000 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Giemsa Dermis (n=10,29) | 6.8690 # positive cells | Standard Deviation 6.19228 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Giemsa All Skin Layers (n=20,58) | 3.4345 # positive cells | Standard Deviation 5.55324 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Haematoxylin + Eosin Epidermis (n=10,29) | 0.0000 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Haematoxylin + Eosin Dermis (n=10,29) | 0.0000 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Haematoxylin + Eosin All Skin Layers (n=20,58) | 0.0000 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE Epidermis (n=10,29) | 1.0603 # positive cells | Standard Deviation 2.30385 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE Dermis (n=10,29) | 14.7776 # positive cells | Standard Deviation 9.84503 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE All Skin layers (n=20,58) | 7.9190 # positive cells | Standard Deviation 9.9038 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + CD 11c Epidermis (n=10,28) | 0.0357 # positive cells | Standard Deviation 0.12237 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + CD 11c Dermis (n=10,29) | 1.0115 # positive cells | Standard Deviation 1.0529 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE+CD 11c All Layers (n=20,57) | 0.5322 # positive cells | Standard Deviation 0.89651 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + Tryptase Epidermis (n=10,28) | 0.0000 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + Tryptase Dermis (n=10,29) | 0.8713 # positive cells | Standard Deviation 0.79919 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | IgE + Tryptase All Skin Layers (n=20,57) | 0.4433 # positive cells | Standard Deviation 0.71586 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Tryptase Epidermis (n=10,29) | 0.0000 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set | Tryptase Dermis (n=10,29) | 6.7741 # positive cells | Standard Deviation 3.64713 |
Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status
Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.
Time frame: Baseline through Day 85
Population: Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGE025 | Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Dermis, lesional | 0.4841 correlation coefficient |
| IGE025 | Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Dermis, non-lesional | 0.2759 correlation coefficient |
| IGE025 | Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Epidermis, lesional | 0.2190 correlation coefficient |
| IGE025 | Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Epidermis, non-lesional | 0.1574 correlation coefficient |
| Placebo IGE025 | Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Epidermis, non-lesional | -0.2310 correlation coefficient |
| Placebo IGE025 | Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Dermis, lesional | -0.0952 correlation coefficient |
| Placebo IGE025 | Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Epidermis, lesional | -0.1142 correlation coefficient |
| Placebo IGE025 | Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Dermis, non-lesional | 0.4947 correlation coefficient |
Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status
Correlation of primary endpoint with The UAS7 which is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.
Time frame: Baseline through Day 85
Population: Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGE025 | Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Dermis, lesional | 0.3305 correlation coefficient |
| IGE025 | Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Dermis, non-lesional | 0.2785 correlation coefficient |
| IGE025 | Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Epidermis, non-lesional | 0.0644 correlation coefficient |
| IGE025 | Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Epidermis, lesional | 0.0021 correlation coefficient |
| Placebo IGE025 | Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Epidermis, non-lesional | 0.1563 correlation coefficient |
| Placebo IGE025 | Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Dermis, lesional | -0.1889 correlation coefficient |
| Placebo IGE025 | Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Dermis, non-lesional | 0.5057 correlation coefficient |
| Placebo IGE025 | Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status | Epidermis, lesional | 0.0101 correlation coefficient |
Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment
The investigator or the person he or she designated and the patient provided scoring of the patient's global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient's condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe
Time frame: Baseline, Day 85
Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Physicians Baseline (n=17,9) | 2.0 score | Standard Deviation 0.87 |
| IGE025 | Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Physicians Week 12, (day 85) (n=17,8) | 0.8 score | Standard Deviation 1.01 |
| IGE025 | Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Patients Baseline (n=17,9) | 2.4 score | Standard Deviation 0.87 |
| IGE025 | Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Patients Week 12, (day 85) (n=17,8) | 0.9 score | Standard Deviation 1.05 |
| Placebo IGE025 | Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Patients Week 12, (day 85) (n=17,8) | 1.9 score | Standard Deviation 0.99 |
| Placebo IGE025 | Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Physicians Baseline (n=17,9) | 2.2 score | Standard Deviation 0.83 |
| Placebo IGE025 | Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Patients Baseline (n=17,9) | 2.4 score | Standard Deviation 0.53 |
| Placebo IGE025 | Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment | Physicians Week 12, (day 85) (n=17,8) | 2.0 score | Standard Deviation 1.31 |
Mean (SD) Serum Free IgE % Change From Baseline by Visit
Time frame: Baseline through Day 85
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 8 % Change (n=20,10) | -96.446 % change | Standard Deviation 2.0162 |
| IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 57 % Change (n=18,8) | -94.460 % change | Standard Deviation 3.0681 |
| IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 29 % Change (n=19,9) | -93.363 % change | Standard Deviation 3.5975 |
| IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 85 % Change (n=16,8) | -94.750 % change | Standard Deviation 3.42 |
| IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 2 % Change (n=19,9) | -96.166 % change | Standard Deviation 2.9216 |
| Placebo IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 85 % Change (n=16,8) | -61.906 % change | Standard Deviation 17.7819 |
| Placebo IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 2 % Change (n=19,9) | -60.475 % change | Standard Deviation 17.933 |
| Placebo IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 8 % Change (n=20,10) | -60.804 % change | Standard Deviation 15.8379 |
| Placebo IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 29 % Change (n=19,9) | -61.456 % change | Standard Deviation 17.234 |
| Placebo IGE025 | Mean (SD) Serum Free IgE % Change From Baseline by Visit | Day 57 % Change (n=18,8) | -61.270 % change | Standard Deviation 18.6447 |
Mean (SD) Serum Free IgE Concentration From Baseline by Visit
Time frame: Baseline through Day 85
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 57 Mean (n=19,8) | 38.502 ng/mL | Standard Deviation 39.5567 |
| IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 1 Mean (n=20,10) | 1037 ng/mL | Standard Deviation 2474 |
| IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 29 Mean (n=20,9) | 41.506 ng/mL | Standard Deviation 40.5322 |
| IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 2 Mean (n= 20,9) | 26.8 ng/mL | Standard Deviation 34.27 |
| IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 85 Mean (n=17,8) | 35.776 ng/mL | Standard Deviation 41.5426 |
| IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 8 Mean (n=20,10) | 24.306 ng/mL | Standard Deviation 29.7698 |
| Placebo IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 85 Mean (n=17,8) | 120.978 ng/mL | Standard Deviation 50.6692 |
| Placebo IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 29 Mean (n=20,9) | 107.881 ng/mL | Standard Deviation 60.1708 |
| Placebo IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 57 Mean (n=19,8) | 122.318 ng/mL | Standard Deviation 51.1087 |
| Placebo IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 8 Mean (n=20,10) | 112.169 ng/mL | Standard Deviation 58.6525 |
| Placebo IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 1 Mean (n=20,10) | 442 ng/mL | Standard Deviation 580.69 |
| Placebo IGE025 | Mean (SD) Serum Free IgE Concentration From Baseline by Visit | Day 2 Mean (n= 20,9) | 111.5 ng/mL | Standard Deviation 60.75 |
Mean (SD) Serum Total IgE % Change From Baseline by Visit
Time frame: Baseline through Day 85
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 8 % Change (n=19,10) | 174.7 Percent Change from Baseline | Standard Deviation 84.93 |
| IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 57 % Change (n=18,8) | 247.8 Percent Change from Baseline | Standard Deviation 134.1 |
| IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 29 % Change (n=19,9) | 247.2 Percent Change from Baseline | Standard Deviation 121.81 |
| IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 85 % Change (n=16,8) | 244.8 Percent Change from Baseline | Standard Deviation 138.28 |
| IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 2 % Change (n=19,10) | 27.1 Percent Change from Baseline | Standard Deviation 20.08 |
| Placebo IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 85 % Change (n=16,8) | -6.9 Percent Change from Baseline | Standard Deviation 24.1 |
| Placebo IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 2 % Change (n=19,10) | 0.2 Percent Change from Baseline | Standard Deviation 5.13 |
| Placebo IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 8 % Change (n=19,10) | -1.5 Percent Change from Baseline | Standard Deviation 9.13 |
| Placebo IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 29 % Change (n=19,9) | -4.0 Percent Change from Baseline | Standard Deviation 12.17 |
| Placebo IGE025 | Mean (SD) Serum Total IgE % Change From Baseline by Visit | Day 57 % Change (n=18,8) | -4.4 Percent Change from Baseline | Standard Deviation 18.59 |
Mean (SD) Serum Total IgE Concentration From Baseline by Visit
Time frame: Baseline through Day 85
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 2 Mean (20,10) | 1152 ng/mL | Standard Deviation 2539 |
| IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 29 Mean (n=20,9) | 2160 ng/mL | Standard Deviation 2688 |
| IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 1 Mean (n=20,10) | 1037 ng/mL | Standard Deviation 2474 |
| IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 57 Mean (n=19,8) | 2430 ng/mL | Standard Deviation 3343 |
| IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 8 Mean (n=20,10) | 1970 ng/mL | Standard Deviation 2992 |
| IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 85 Mean (n=17,8) | 2222 ng/mL | Standard Deviation 2931 |
| Placebo IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 85 Mean (n=17,8) | 475 ng/mL | Standard Deviation 616.8 |
| Placebo IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 1 Mean (n=20,10) | 442 ng/mL | Standard Deviation 580.7 |
| Placebo IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 2 Mean (20,10) | 447 ng/mL | Standard Deviation 587.5 |
| Placebo IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 8 Mean (n=20,10) | 449 ng/mL | Standard Deviation 593.1 |
| Placebo IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 29 Mean (n=20,9) | 462 ng/mL | Standard Deviation 628.7 |
| Placebo IGE025 | Mean (SD) Serum Total IgE Concentration From Baseline by Visit | Day 57 Mean (n=19,8) | 490 ng/mL | Standard Deviation 648 |
Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit
The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
Time frame: Baseline to Day 85
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Day 29 was an optional sampling time point in this paramter. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D8 (n=19,10) Change | 0.42 # positive cells | Standard Deviation 7.613 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 29(n=5,0 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D29 (n=4,0) | 15.63 # positive cells | Standard Deviation 10.636 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 29 (n=4,0) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D29 (n=4,0) Change | 0.93 # positive cells | Standard Deviation 15.472 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 140 (n=16,7) Chg | 1.27 # positive cells | Standard Deviation 3.599 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 8 (n=18,10 ) Chge | -1.33 # positive cells | Standard Deviation 5.141 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 8 (n=19,10) | 0.49 # positive cells | Standard Deviation 0.754 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 140(n=6,5 ) | 7.57 # positive cells | Standard Deviation 2.589 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 8 (n=18,10) Change | 0.14 # positive cells | Standard Deviation 0.636 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 140(n=18,8) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 29 (n=4,0) | 0.32 # positive cells | Standard Deviation 0.367 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Baseline (n=19,8) | 6.08 # positive cells | Standard Deviation 3.764 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 29 (n=4,0) Change | 0.07 # positive cells | Standard Deviation 0.094 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 29 (n=4,0 ) | 3.88 # positive cells | Standard Deviation 1.876 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 85 (n=18,8) | 0.47 # positive cells | Standard Deviation 0.66 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 29 (n=4,0) Chg | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 85 (n=17,8) Change | 0.14 # positive cells | Standard Deviation 0.438 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 8 (n=11,10) Change | 2.07 # positive cells | Standard Deviation 6.576 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 140(n=17,8) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 29 (n=5,0) | 13.08 # positive cells | Standard Deviation 7.275 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 29(n=5,0 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional day 29 (n=5,0) Change | 0.78 # positive cells | Standard Deviation 10.054 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Baseline (n=19,8) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 85 (n=10,7) | 11.01 # positive cells | Standard Deviation 3.615 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 140 (n=17,7) | 0.02 # positive cells | Standard Deviation 0.097 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 85 (n=10,6) Change | 0.46 # positive cells | Standard Deviation 5.775 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Baseline (n=19,10) | 9.47 # positive cells | Standard Deviation 5.07 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day140(n=16,7) Chg | 0.03 # positive cells | Standard Deviation 0.1 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 140(n=6,4) Change | -0.61 # positive cells | Standard Deviation 1.281 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 29(n=4,0 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 8 (n=18,10) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epdiermis non lesional Day 85(n=18,8) Change | -0.31 # positive cells | Standard Deviation 2.239 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 85(n=10,6 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Baseline(n=19,10) | 16.81 # positive cells | Standard Deviation 6.868 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 8 (n=11,8) Chg | 0.31 # positive cells | Standard Deviation 1.093 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 140(n=17,7) | 0.81 # positive cells | Standard Deviation 0.742 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 140 (n=16,7 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 140(n=16,7) Change | -0.07 # positive cells | Standard Deviation 1.283 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 8 (n=11,8) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Baseline(n=19,8) | 0.95 # positive cells | Standard Deviation 1.066 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 85(n=10,5 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 8(n=11,10) | 0.63 # positive cells | Standard Deviation 0.725 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 29 (n=5,0) | 0.12 # positive cells | Standard Deviation 0.268 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 8(n=19,10) | 17.80 # positive cells | Standard Deviation 8.144 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 29 (n=4,0) Chg | 0.67 # positive cells | Standard Deviation 4.816 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 8(n=18,10) Change | 1.21 # positive cells | Standard Deviation 9.816 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 85(n=10,7) | 10.68 # positive cells | Standard Deviation 6.16 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Baseline(n=19,8 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 85 (n=17,8) Change | -0.01 # positive cells | Standard Deviation 5.75 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 29 (n=5,0) Chg | 0.08 # positive cells | Standard Deviation 0.179 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 140(n=17,7) | 12.05 # positive cells | Standard Deviation 4.212 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 29 (n=4,0 ) Chge | -1.62 # positive cells | Standard Deviation 1.811 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 140 (n=16,7) Change | 0.69 # positive cells | Standard Deviation 5.439 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Baseline(n=19,8) | 9.00 # positive cells | Standard Deviation 4.57 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 8(n=11,10) | 10.15 # positive cells | Standard Deviation 6.629 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 8(n=11,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 8(n=11,8) Change | 0.60 # positive cells | Standard Deviation 4.374 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 85 (n=18,8) | 7.66 # positive cells | Standard Deviation 4.076 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 29(n=5,0) | 12.42 # positive cells | Standard Deviation 5.175 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 8(n=11,8 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 29(n=5,0) Change | 5.39 # positive cells | Standard Deviation 5.412 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 85(n=10,7) | 11.07 # positive cells | Standard Deviation 6.023 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 29(n=5,0 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 29(n=4,0) | 15.58 # positive cells | Standard Deviation 5.07 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 29(n=5,0 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 29(n=4,0) Change | -0.88 # positive cells | Standard Deviation 1.928 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 85 (n=10,6) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 85(n=18,8) Change | 19.33 # positive cells | Standard Deviation 7.741 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 29(n=5,0 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 85(n=17,8) Change | 1.94 # positive cells | Standard Deviation 10.126 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 140(n=6,5 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 140(n=17,7) | 21.14 # positive cells | Standard Deviation 11.3 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 29 (n=4,0) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 140(n=16,7) Change | 3.36 # positive cells | Standard Deviation 11.994 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 85(n=10,7) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional baseline(n=19,8) | 14.28 # positive cells | Standard Deviation 5.351 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 85(n=10,6 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 8(n=11,10) | 17.84 # positive cells | Standard Deviation 10.403 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 85 (n=10,5) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 8(n=11,8) Change | 2.86 # positive cells | Standard Deviation 7.576 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 85(n=10,6) Chg | -0.02 # positive cells | Standard Deviation 0.063 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 29(n=5,0) | 17.12 # positive cells | Standard Deviation 8.146 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Baseline (n=19,10) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 85(n=10,5 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epdiermis lesional Day 29(n=5,0) Change | 0.12 # positive cells | Standard Deviation 1.726 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 85 (n=17,8) Chg | 0.54 # positive cells | Standard Deviation 3.753 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 140 (n=7,5) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 8(n=19,10) | 0.40 # positive cells | Standard Deviation 0.593 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 29 (n=4,0) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 8(n=18,10) Change | 0.24 # positive cells | Standard Deviation 0.55 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 140(n=6,5 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 29(n=4,0) | 0.39 # positive cells | Standard Deviation 0.347 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 8 (n=19,10) | 0.02 # positive cells | Standard Deviation 0.092 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 29(n=4,0) Change | -0.21 # positive cells | Standard Deviation 0.448 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 140 (n=7,4) Chg | -0.03 # positive cells | Standard Deviation 0.076 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 85(n=18,8) | 0.22 # positive cells | Standard Deviation 0.361 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 140(n=6,5 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 85 (n=17,8) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 140(n=17,7) | 0.16 # positive cells | Standard Deviation 0.215 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 140(n=6,4 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 140(n=16,7) Change | -0.04 # positive cells | Standard Deviation 0.344 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 29(n=5,0 ) Chge | 2.57 # positive cells | Standard Deviation 12.812 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Baseline(n=19,8) | 0.34 # positive cells | Standard Deviation 0.644 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Baseline(n=19,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 8(n=18,10) Chg | 0.02 # positive cells | Standard Deviation 0.094 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 85(n=10,7) | 0.14 # positive cells | Standard Deviation 0.313 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Baseline (n=19,10) | 6.55 # positive cells | Standard Deviation 3.988 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 85(n=10,6) Change | -0.01 # positive cells | Standard Deviation 0.356 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 140(n=6,4 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 140(n=6,5) | 0.03 # positive cells | Standard Deviation 0.082 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 8(n=19,10 ) | 0.01 # positive cells | Standard Deviation 0.046 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 140(n=6,4) Change | -0.53 # positive cells | Standard Deviation 1.129 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 8 (n=19,10) | 7.14 # positive cells | Standard Deviation 4.479 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Baseline(n=19,10) | 5.74 # positive cells | Standard Deviation 3.278 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 29(n=5,0) Chg | 3.80 # positive cells | Standard Deviation 3.023 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 8(n=19,10) | 7.10 # positive cells | Standard Deviation 5.02 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 140 (n=18,10 ) | 6.69 # positive cells | Standard Deviation 5.409 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 8 (n=18,10) Change | 1.19 # positive cells | Standard Deviation 4.798 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 85(n=10,7) | 6.76 # positive cells | Standard Deviation 3.082 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 29(n=4,0) | 8.45 # positive cells | Standard Deviation 5.369 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 85(n=10,6 ) | 5.96 # positive cells | Standard Deviation 2.589 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 8(n=11,10) | 7.55 # positive cells | Standard Deviation 4.953 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D140 (n=6,5) | 0.53 # positive cells | Standard Deviation 0.555 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 8(n=11,8) Change | 1.02 # positive cells | Standard Deviation 5.174 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Baseline (n=19,10 ) | 6.91 # positive cells | Standard Deviation 4.751 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 29(n=5,0) | 10.14 # positive cells | Standard Deviation 6.133 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D140 (n=6,5) Change | 0.12 # positive cells | Standard Deviation 0.599 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 29(n=5,0) Change | 2.48 # positive cells | Standard Deviation 5.639 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 85 (n=10,5 ) Chge | -1.56 # positive cells | Standard Deviation 7.155 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 85(n=10,7) | 7.19 # positive cells | Standard Deviation 3.022 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional baseline (n=19,10) | 17.86 # positive cells | Standard Deviation 7.322 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 85(n=10,6) Change | 0.98 # positive cells | Standard Deviation 3.556 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 8 (n=19,10 ) | 5.51 # positive cells | Standard Deviation 4.142 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 140(n=6,5) | 7.73 # positive cells | Standard Deviation 6.774 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D8 (n=19,10) | 18.33 # positive cells | Standard Deviation 8.971 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 140(n=6,4) | 1.87 # positive cells | Standard Deviation 7.44 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 140 (n=17,7) | 7.77 # positive cells | Standard Deviation 4.296 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 8 (n=19,10) | 10.29 # positive cells | Standard Deviation 4.555 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 8 (n=19,10) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional day 8(n=19,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 85 (n=18,8) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 8 (n=11,10) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 8(n=11,8) Change | 0.30 # positive cells | Standard Deviation 0.534 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 8(n=11,8) Change | 2.58 # positive cells | Standard Deviation 4.315 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 85(n=10,6) Change | 2.11 # positive cells | Standard Deviation 5.917 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 140(n=6,5) | 10.92 # positive cells | Standard Deviation 6.704 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 140(n=6,4) Change | 5.12 # positive cells | Standard Deviation 6.41 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Baseline (n=19,10) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 85 (n=18,8 ) | 4.75 # positive cells | Standard Deviation 3.397 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 85 (n=17,8 ) Chge | -2.34 # positive cells | Standard Deviation 3.618 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 8(n=18,10 ) Chge | 0.01 # positive cells | Standard Deviation 0.047 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 8(n=11,10 ) | 6.71 # positive cells | Standard Deviation 4.309 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 29(n=4,0 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 29(n=4,0 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 85(n=17,8) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 85(n=16,8 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 140(n=17,7 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 140(n=16,7 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 8(n=11,8 ) Chge | -1.75 # positive cells | Standard Deviation 6.143 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Baseline(n=19,8 ) | 0.02 # positive cells | Standard Deviation 0.071 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 8(n=11,10 ) | 0.05 # positive cells | Standard Deviation 0.129 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 8(n=11,8 ) Chge | 0.03 # positive cells | Standard Deviation 0.159 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 140 (n=18,10 ) Chge | -1.35 # positive cells | Standard Deviation 5.078 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 29(n=5,0 ) | 8.09 # positive cells | Standard Deviation 11.851 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 29(n=5,0 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 140(n=6,4 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 85 (n=18,8) | 0.03 # positive cells | Standard Deviation 0.103 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 140 (n=6,4 ) Chge | -1.20 # positive cells | Standard Deviation 7.929 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 8 (n=11,10) | 7.19 # positive cells | Standard Deviation 3.618 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 8 (n=11,8) Chg | 0.71 # positive cells | Standard Deviation 2.809 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Baseline(n=19,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 8(n=18,10 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 29(n=4,0 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 85(n=17,8) Chg | 0.04 # positive cells | Standard Deviation 0.1 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 85(n=17,8 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 85(n=16,8 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 140 (n=17,7 ) | 0.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Baseline (n=19,8) | 0.01 # positive cells | Standard Deviation 0.046 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional day 8 (n=11,10) | 0.33 # positive cells | Standard Deviation 1.085 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 8 (n=18,10) Chg | 1.14 # positive cells | Standard Deviation 2.989 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 29 (n=4,0) | 8.22 # positive cells | Standard Deviation 4.981 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 29(n=5,0) | 10.20 # positive cells | Standard Deviation 4.658 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 85(n=10,6) Chg | 0.39 # positive cells | Standard Deviation 4.141 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 140(n=7,5) | 6.59 # positive cells | Standard Deviation 6.335 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 140(n=7,4) Chg | 2.68 # positive cells | Standard Deviation 6.641 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 85(n=10,7) | 0.68 # positive cells | Standard Deviation 0.691 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Baseline (n=19,8) | 0.42 # positive cells | Standard Deviation 0.459 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 8(n=11,10) | 0.55 # positive cells | Standard Deviation 0.561 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 8(n=11,10) Change | 0.14 # positive cells | Standard Deviation 0.604 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 29(n=5,0) | 0.28 # positive cells | Standard Deviation 0.438 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 29(n=5,0) Change | -0.33 # positive cells | Standard Deviation 0.574 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 85(n=10,7) | 0.46 # positive cells | Standard Deviation 0.558 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 85(n=10,6) Change | 0.07 # positive cells | Standard Deviation 0.672 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 140(n=7,5) | 0.84 # positive cells | Standard Deviation 0.983 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 140(n=7,4) Change | 0.27 # positive cells | Standard Deviation 0.843 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Baseline(n=19,10) | 9.97 # positive cells | Standard Deviation 4.924 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 8(n=19,10) | 10.81 # positive cells | Standard Deviation 5.359 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 8(n=18,10) Change | 0.72 # positive cells | Standard Deviation 6.503 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional Baseline (n= 19,10) | 1.06 # positive cells | Standard Deviation 1.077 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional Day 8 (n=19,10) | 1.41 # positive cells | Standard Deviation 1.313 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 8(n=18,10) Chge | 0.39 # positive cells | Standard Deviation 1.351 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 29(n=4,0) | 1.00 # positive cells | Standard Deviation 0 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 29(n=4,0) Chg | 0.70 # positive cells | Standard Deviation 0.383 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 85(n=18,8) | 1.19 # positive cells | Standard Deviation 0.806 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 85(n=17,8) Chge | 0.04 # positive cells | Standard Deviation 1.216 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 140(n=17,7) | 1.25 # positive cells | Standard Deviation 1.63 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 140(n=17,7) Chge | 0.04 # positive cells | Standard Deviation 1.216 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional baseline (n=19,8) | 1.17 # positive cells | Standard Deviation 1.363 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D8 (n=11,10) | 1.63 # positive cells | Standard Deviation 1.425 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D8 (n=11,8) Change | 0.39 # positive cells | Standard Deviation 1.153 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D29 (n=5,0) | 1.56 # positive cells | Standard Deviation 1.609 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D29 (n=5,0) Change | 0.88 # positive cells | Standard Deviation 1.677 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D85 (n=10,7) | 1.18 # positive cells | Standard Deviation 0.577 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D85 (n=10,6) Change | -0.06 # positive cells | Standard Deviation 1.234 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D85 (n=18,8) | 17.05 # positive cells | Standard Deviation 5.656 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D85 (n=17,8) Change | -1.52 # positive cells | Standard Deviation 7.562 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D140 (n=17,7) | 22.85 # positive cells | Standard Deviation 11.189 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D140 (n=16,7) Change | 3.51 # positive cells | Standard Deviation 11.162 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional baseline(n=19,8) | 27.14 # positive cells | Standard Deviation 12.552 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D8(n=11,10) | 28.85 # positive cells | Standard Deviation 22.24 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D29 (n=5,0) Change | -0.28 # positive cells | Standard Deviation 5.403 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D85 (n=10,7) | 24.82 # positive cells | Standard Deviation 13.724 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D85 (n=10,6) Change | -0.09 # positive cells | Standard Deviation 15 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D140 (n=6,5) | 37.33 # positive cells | Standard Deviation 21.229 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D140 (n=6,4) Change | 11.30 # positive cells | Standard Deviation 23.485 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Baseline (n=19,10) | 0.37 # positive cells | Standard Deviation 0.593 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 140 (n=17,7) | 0.36 # positive cells | Standard Deviation 0.47 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 29(n=4,0) | 6.87 # positive cells | Standard Deviation 1.427 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 29(n=4,0) Change | -1.78 # positive cells | Standard Deviation 3.096 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 85(n=18,8) | 12.71 # positive cells | Standard Deviation 9.845 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 85(n=18,8) Change | 2.61 # positive cells | Standard Deviation 8.287 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 140(n=17,7) | 11.80 # positive cells | Standard Deviation 6.96 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 140(n=16,7) Change | 1.03 # positive cells | Standard Deviation 5.717 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Baseline(n=19,8) | 12.75 # positive cells | Standard Deviation 6.934 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 8 (n=11,10) | 14.93 # positive cells | Standard Deviation 8.543 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 140 (n=7,5) | 12.42 # positive cells | Standard Deviation 7.6 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 140(n=7,4) Change | 0.93 # positive cells | Standard Deviation 10.179 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 140 (n=16,7) Chge | 0.023 # positive cells | Standard Deviation 3.866 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional baseline(n=19,8) | 7.64 # positive cells | Standard Deviation 3.71 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 8(n=11,10) | 11.25 # positive cells | Standard Deviation 5.742 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 85(n=10,6) Change | -0.20 # positive cells | Standard Deviation 0.847 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 140(n=6,5) | 0.03 # positive cells | Standard Deviation 0.082 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Baseline (n=19,10) | 0.99 # positive cells | Standard Deviation 1.4 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 8 (n=19,10) | 1.20 # positive cells | Standard Deviation 1.428 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 8 (n=18,10) Change | 0.33 # positive cells | Standard Deviation 1.287 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 29 (n=4,0) | 1.43 # positive cells | Standard Deviation 1.144 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 29 (n=4,0) change | -0.13 # positive cells | Standard Deviation 0.922 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 85(n=18,8) | 0.69 # positive cells | Standard Deviation 1.528 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 29(n=5,0) | 14.06 # positive cells | Standard Deviation 4.272 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 29(n=5,0) Change | 3.74 # positive cells | Standard Deviation 4.844 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 85(n=10,6) Change | 2.10 # positive cells | Standard Deviation 5.703 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 140(n=6,5) | 9.88 # positive cells | Standard Deviation 4.399 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 140(n=6,4) Change | 2.41 # positive cells | Standard Deviation 3.792 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Baseline (n=19,10) | 10.59 # positive cells | Standard Deviation 6.616 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 8 (n=19,10) | 12.00 # positive cells | Standard Deviation 6.37 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 8 (n=18,10) Change | 1.49 # positive cells | Standard Deviation 5.924 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 29 (n=4,0) | 10.08 # positive cells | Standard Deviation 2.062 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 29 (n=4,0) Change | -0.47 # positive cells | Standard Deviation 2.968 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 85 (n=18,8) | 10.93 # positive cells | Standard Deviation 6.046 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 29(n=5,0) Change | 3.20 # positive cells | Standard Deviation 4.25 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 85(n=10,7) | 17.20 # positive cells | Standard Deviation 6.815 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 85(n=10,6) Change | 3.41 # positive cells | Standard Deviation 7.859 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 140(n=6,5) | 12.81 # positive cells | Standard Deviation 10.305 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 140(n=6,4) Change | 2.58 # positive cells | Standard Deviation 11.073 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 8(n=11,8) Change | -0.46 # positive cells | Standard Deviation 1.193 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 29(n=5,0) | 1.52 # positive cells | Standard Deviation 1.927 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 8(n=11,10) | 0.43 # positive cells | Standard Deviation 0.568 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 29(n=5,0) | 0.20 # positive cells | Standard Deviation 0.346 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 29(n=5,0) Change | 0.08 # positive cells | Standard Deviation 0.363 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 29(n=4,0) Change | 1.80 # positive cells | Standard Deviation 1.849 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 85 (n=18,8) Change | 5.51 # positive cells | Standard Deviation 3.725 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 85 (n=17,8) Change | -0.46 # positive cells | Standard Deviation 2.757 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 140(n=17,7) Change | 4.30 # positive cells | Standard Deviation 2.357 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 140(n=16,7) Change | -1.74 # positive cells | Standard Deviation 2.726 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis lesional Baseline(n=19,8) | 5.67 # positive cells | Standard Deviation 2.983 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 8 (n=18,10) Chge | 0.99 # positive cells | Standard Deviation 5.511 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 29 (n=4,0) | 12.00 # positive cells | Standard Deviation 4.578 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 29 (n=4,0) Chge | 1.05 # positive cells | Standard Deviation 2.996 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 85 (n=18,8) | 8.75 # positive cells | Standard Deviation 4.492 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 85 (n=17,8) Chge | -1.62 # positive cells | Standard Deviation 5.338 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 140 (n=17,7) | 9.89 # positive cells | Standard Deviation 3.427 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Baseline(n=19,8 ) | 8.29 # positive cells | Standard Deviation 5.189 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D8(n=11,8) Change | 3.56 # positive cells | Standard Deviation 16.705 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D29 (n=5,0) | 27.04 # positive cells | Standard Deviation 11.509 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 140 (n=16,7) Change | -0.08 # positive cells | Standard Deviation 0.554 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Baseline(n=19,10) | 0.20 # positive cells | Standard Deviation 0.306 |
| IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 85(n=17,8) Change | 0.00 # positive cells | Standard Deviation 0.473 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Baseline (n=19,10 ) | 6.80 # positive cells | Standard Deviation 8.61 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 140 (n=18,10 ) Chge | -4.86 # positive cells | Standard Deviation 7.348 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 140(n=17,7) | 0.58 # positive cells | Standard Deviation 0.942 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 85(n=10,6) Change | -0.78 # positive cells | Standard Deviation 1.3489 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D8(n=11,8) Change | 0.99 # positive cells | Standard Deviation 8.677 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 140(n=17,7) Chge | -0.75 # positive cells | Standard Deviation 0.939 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 29(n=4,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 140(n=6,5) | 19.80 # positive cells | Standard Deviation 12.617 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 140(n=6,4) Change | -0.15 # positive cells | Standard Deviation 11.3 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional baseline (n=19,8) | 3.79 # positive cells | Standard Deviation 8.028 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 29(n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 8(n=11,10) | 0.08 # positive cells | Standard Deviation 0.14 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D8 (n=11,10) | 1.19 # positive cells | Standard Deviation 1.329 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 8(n=11,8) Change | -0.11 # positive cells | Standard Deviation 0.236 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Baseline (n=19,10) | 1.07 # positive cells | Standard Deviation 1.018 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 8(n=11,8) Change | 1.42 # positive cells | Standard Deviation 5.978 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 8(n=19,10 ) | 0.02 # positive cells | Standard Deviation 0.063 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D8 (n=11,8) Change | -2.74 # positive cells | Standard Deviation 8.466 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 85(n=10,6) Change | 3.03 # positive cells | Standard Deviation 2.659 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 8 (n=18,10) Chge | -1.31 # positive cells | Standard Deviation 2.493 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 140(n=6,5) | 8.87 # positive cells | Standard Deviation 4.017 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D29 (n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 140(n=6,4) Change | 2.88 # positive cells | Standard Deviation 4.907 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 8 (n=19,10) | 1.46 # positive cells | Standard Deviation 1.639 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 29 (n=4,0 ) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D29 (n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 85(n=10,7) | 19.80 # positive cells | Standard Deviation 12.617 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D85 (n=10,7) | 0.46 # positive cells | Standard Deviation 0.378 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 8 (n=18,10) Change | 0.39 # positive cells | Standard Deviation 1.826 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 8(n=18,10 ) Chge | 0.02 # positive cells | Standard Deviation 0.063 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 85 (n=18,8) Change | 7.62 # positive cells | Standard Deviation 4.288 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 29(n=4,0 ) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D85 (n=18,8) | 23.73 # positive cells | Standard Deviation 19.031 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 29(n=4,0 ) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 29 (n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D85 (n=17,8) Change | -1.23 # positive cells | Standard Deviation 15.514 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 85(n=16,8 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 85(n=10,6) Change | 0.98 # positive cells | Standard Deviation 10.706 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 140(n=17,7 ) | 0.03 # positive cells | Standard Deviation 0.076 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D140 (n=17,7) | 15.58 # positive cells | Standard Deviation 9.691 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 8(n=11,10 ) | 4.80 # positive cells | Standard Deviation 4.512 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 29 (n=4,0) change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 140(n=16,7 ) Chge | 0.03 # positive cells | Standard Deviation 0.076 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D140 (n=16,7) Change | -11.51 # positive cells | Standard Deviation 15.849 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Baseline(n=19,8 ) | 0.03 # positive cells | Standard Deviation 0.071 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 85 (n=17,8 ) Chge | -2.16 # positive cells | Standard Deviation 6.705 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 85 (n=18,8) | 9.17 # positive cells | Standard Deviation 2.55 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 8(n=11,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional baseline(n=19,8) | 22.46 # positive cells | Standard Deviation 9.7 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 8(n=11,8 ) Chge | -0.03 # positive cells | Standard Deviation 0.071 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 140 (n=18,10 ) | 3.12 # positive cells | Standard Deviation 3.12 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 85 (n=17,8) Change | 0.35 # positive cells | Standard Deviation 3.067 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 8(n=11,8 ) Chge | 0.18 # positive cells | Standard Deviation 3.394 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D8(n=11,10) | 22.12 # positive cells | Standard Deviation 8.669 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D29 (n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 29(n=5,0 ) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 140(n=6,5) | 0.84 # positive cells | Standard Deviation 0.518 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 140(n=6,4 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D29 (n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 29(n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 140 (n=6,4 ) Chge | 4.50 # positive cells | Standard Deviation 5.073 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D85 (n=10,7) | 22.59 # positive cells | Standard Deviation 16.719 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 8 (n=11,10) | 6.99 # positive cells | Standard Deviation 3.451 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 8(n=11,10) | 0.90 # positive cells | Standard Deviation 0.92 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 85 (n=18,8) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D85 (n=10,6) Change | 4.07 # positive cells | Standard Deviation 22.288 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Baseline(n=19,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 29 (n=4,0) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional day 8(n=19,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 85(n=10,7) | 8.77 # positive cells | Standard Deviation 2.606 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 8(n=18,10 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D140 (n=6,5) | 22.59 # positive cells | Standard Deviation 16.719 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 29(n=4,0 ) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 29 (n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 29(n=4,0 ) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day140(n=16,7) Chg | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis lesional D140 (n=6,4) Change | 12.43 # positive cells | Standard Deviation 9.21 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 85(n=17,8 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 85(n=10,6) Change | -0.97 # positive cells | Standard Deviation 3.885 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 85(n=16,8 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 85 (n=17,8) Change | -0.46 # positive cells | Standard Deviation 1.249 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 8(n=11,8) Change | -0.04 # positive cells | Standard Deviation 0.68 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Baseline (n=19,8) | 0.08 # positive cells | Standard Deviation 0.149 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 140 (n=17,7) | 0.75 # positive cells | Standard Deviation 1.245 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 8 (n=19,10) | 8.37 # positive cells | Standard Deviation 2.305 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 140(n=6,5) | 8.66 # positive cells | Standard Deviation 2.136 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 8 (n=18,10) Chg | 1.17 # positive cells | Standard Deviation 3.03 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 29(n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 8 (n=11,8) Chg | 0.88 # positive cells | Standard Deviation 2.998 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 140(n=17,7) Change | 5.09 # positive cells | Standard Deviation 3.523 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 29(n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 85(n=10,7) | 6.93 # positive cells | Standard Deviation 3.135 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 85(n=10,7) | 0.47 # positive cells | Standard Deviation 0.432 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 85(n=10,6) Chg | 1.67 # positive cells | Standard Deviation 2.047 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 29(n=4,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 140(n=7,5) | 6.79 # positive cells | Standard Deviation 1.635 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 140(n=6,4) Change | -0.98 # positive cells | Standard Deviation 3.444 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 140(n=7,4) Chg | 1.97 # positive cells | Standard Deviation 2.049 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 85(n=18,8) | 11.46 # positive cells | Standard Deviation 7.9 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 140 (n=16,7) Change | -0.09 # positive cells | Standard Deviation 2.092 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 140 (n=17,7) | 8.01 # positive cells | Standard Deviation 2.744 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Baseline (n=19,8) | 0.49 # positive cells | Standard Deviation 0.892 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 85(n=18,8) Change | -2.09 # positive cells | Standard Deviation 5.865 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 8(n=11,10) | 0.84 # positive cells | Standard Deviation 0.913 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Baseline (n=19,10) | 10.11 # positive cells | Standard Deviation 2.91 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 8(n=11,10) Change | 0.11 # positive cells | Standard Deviation 1.058 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 140(n=17,7) | 7.22 # positive cells | Standard Deviation 5.823 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 29(n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 140(n=16,7) Change | -2.65 # positive cells | Standard Deviation 1.686 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 29(n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 140(n=16,7) Change | -6.15 # positive cells | Standard Deviation 10.618 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 85(n=10,7) | 0.47 # positive cells | Standard Deviation 0.499 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 8 (n=19,10) | 9.20 # positive cells | Standard Deviation 3.319 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 85(n=10,6) Change | -0.09 # positive cells | Standard Deviation 0.873 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Baseline(n=19,8) | 11.94 # positive cells | Standard Deviation 6.245 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 140(n=7,5) | 0.94 # positive cells | Standard Deviation 0.969 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 29(n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis lesional Day 140(n=7,4) Change | 0.98 # positive cells | Standard Deviation 0.642 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 8 (n=11,10) | 12.56 # positive cells | Standard Deviation 8.894 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Baseline(n=19,10) | 12.46 # positive cells | Standard Deviation 7.954 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 8 (n=18,10) Change | -0.91 # positive cells | Standard Deviation 3.078 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 8(n=19,10) | 8.66 # positive cells | Standard Deviation 4.495 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 140 (n=7,5) | 14.58 # positive cells | Standard Deviation 19.403 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis non lesional Day 8(n=18,10) Change | -3.80 # positive cells | Standard Deviation 5.984 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 29 (n=4,0) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional Baseline (n= 19,10) | 1.25 # positive cells | Standard Deviation 0.584 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 29 (n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional Day 8 (n=19,10) | 0.95 # positive cells | Standard Deviation 0.92 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 140 (n=16,7) Chge | -2.43 # positive cells | Standard Deviation 2.234 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 8(n=18,10) Chge | -0.30 # positive cells | Standard Deviation 1.255 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 29(n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 29(n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional baseline(n=19,8) | 10.18 # positive cells | Standard Deviation 3.804 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 29(n=4,0) Chg | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 29 (n=4,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 85(n=18,8) | 0.53 # positive cells | Standard Deviation 0.544 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 8(n=11,10) | 10.84 # positive cells | Standard Deviation 3.865 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis Non lesional D 85(n=17,8) Chge | -0.84 # positive cells | Standard Deviation 0.524 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 85 (n=17,8) Chge | -1.02 # positive cells | Standard Deviation 4.166 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis lesional Baseline(n=19,8) | 4.63 # positive cells | Standard Deviation 2.448 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 8(n=11,10) | 6.12 # positive cells | Standard Deviation 3.847 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 8(n=11,8) Change | 0.88 # positive cells | Standard Deviation 2.679 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 29(n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 29(n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 85(n=10,7) | 6.70 # positive cells | Standard Deviation 6.69 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 85(n=10,6) Change | 1.48 # positive cells | Standard Deviation 6.628 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 140(n=6,5) | 6.37 # positive cells | Standard Deviation 10.549 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Baseline (n=19,10) | 10.99 # positive cells | Standard Deviation 4.498 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis non lesional Day 8 (n=19,10) | 9.68 # positive cells | Standard Deviation 3.057 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 29 (n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 140(n=17,8) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 29(n=5,0 ) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 85 (n=18,8 ) | 5.28 # positive cells | Standard Deviation 4.906 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Day 85(n=17,8) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 140(n=6,4) | 3.57 # positive cells | Standard Deviation 10.671 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 140 (n=16,7) Change | -3.79 # positive cells | Standard Deviation 2.284 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Baseline(n=19,8) | 7.31 # positive cells | Standard Deviation 2.468 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 29(n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 85(n=10,7) | 9.51 # positive cells | Standard Deviation 2.891 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Baseline (n=19,10) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 8 (n=19,10) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 8 (n=18,10) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 85 (n=18,8) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 85 (n=17,8) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 29(n=5,0 ) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis non lesional Day 140(n=18,8) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Baseline (n=19,8) | 0.03 # positive cells | Standard Deviation 0.071 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 8 (n=11,10) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 8 (n=11,8) Chge | -0.03 # positive cells | Standard Deviation 0.071 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 85 (n=10,6) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 85 (n=10,5) Chge | -.04 # positive cells | Standard Deviation 0.089 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 140(n=6,5 ) | 1.00 # positive cells | Standard Deviation 2.236 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Epidermis lesional Day 140(n=6,4 ) Chge | 1.25 # positive cells | Standard Deviation 2.5 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 8 (n=19,10 ) | 4.47 # positive cells | Standard Deviation 4.529 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 8 (n=18,10 ) Chge | -2.33 # positive cells | Standard Deviation 4.75 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis non lesional Day 29 (n=4,0 ) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Baseline(n=19,8 ) | 4.79 # positive cells | Standard Deviation 5.931 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 29 (n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 29(n=5,0 ) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 85(n=10,6 ) | 0.03 # positive cells | Standard Deviation 0.082 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 29 (n=4,0) Chg | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 29(n=5,0 ) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 85(n=10,5 ) Chge | 0.04 # positive cells | Standard Deviation 0.089 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis lesional Day 140(n=6,5 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 85 (n=18,8) | 8.33 # positive cells | Standard Deviation 3.547 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Baseline (n=19,10) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 85 (n=17,8) Chg | 1.35 # positive cells | Standard Deviation 3.839 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 8 (n=19,10) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 8(n=18,10) Chg | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 29(n=5,0 ) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 85(n=10,6 ) | 10.30 # positive cells | Standard Deviation 15.647 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 85 (n=10,5 ) Chge | 6.36 # positive cells | Standard Deviation 9.563 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 140 (n=17,7) | 6.95 # positive cells | Standard Deviation 1.812 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Day 140 (n=16,7) Chg | -0.62 # positive cells | Standard Deviation 3.002 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 29 (n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Baseline (n=19,8) | 6.41 # positive cells | Standard Deviation 2.658 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Giemsa Dermis lesional Day 140(n=6,5 ) | 9.44 # positive cells | Standard Deviation 10.468 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 29 (n=4,0) Chg | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 85(n=17,8) Chg | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis non lesional Day 140 (n=17,7) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional day 8 (n=11,10) | 0.10 # positive cells | Standard Deviation 0.316 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 140 (n=17,7 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 8 (n=11,8) Chg | 0.05 # positive cells | Standard Deviation 0.334 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis non lesional Day 140 (n=16,7 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 29 (n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Baseline(n=19,8 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 8(n=11,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 8(n=11,8 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 29(n=5,0 ) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 29(n=5,0 ) Chge | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 29 (n=5,0) Chg | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 85(n=10,7) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 85(n=10,6 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 85(n=10,6) Chg | -0.10 # positive cells | Standard Deviation 0.167 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 85(n=10,5 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 140 (n=7,5) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Epidermis lesional Day 140 (n=7,4) Chg | -0.10 # positive cells | Standard Deviation 0.2 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 140(n=6,5 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Epidermis lesional Day 140(n=6,4 ) Chge | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | H&E Dermis non lesional Baseline(n=19,10 ) | 0.00 # positive cells | Standard Deviation 0 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis non lesional Baseline (n=19,10) | 7.20 # positive cells | Standard Deviation 3.045 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | Tryptase Dermis lesional Day 29(n=5,0) Chg | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D85 (n=10,6) Change | -4.06 # positive cells | Standard Deviation 9.384 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D140 (n=6,5) | 0.18 # positive cells | Standard Deviation 0.171 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Epidermis lesional D140 (n=6,5) Change | -6.37 # positive cells | Standard Deviation 11.503 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional baseline (n=19,10) | 22.97 # positive cells | Standard Deviation 12.248 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D8 (n=19,10) | 20.22 # positive cells | Standard Deviation 10.861 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D8 (n=19,10) Change | -2.75 # positive cells | Standard Deviation 6.149 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D29 (n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD11c Dermis non lesional D29 (n=4,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Baseline (n=19,10) | 0.68 # positive cells | Standard Deviation 1.151 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 8 (n=19,10) | 0.34 # positive cells | Standard Deviation 0.422 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 8 (n=18,10) Change | -0.34 # positive cells | Standard Deviation 1.091 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 29 (n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 29 (n=4,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Epidermis non lesional Day 85 (n=18,8) | 0.30 # positive cells | Standard Deviation 0.283 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 8 (n=11,10) Change | 1.58 # positive cells | Standard Deviation 7.177 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 29 (n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional day 29 (n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 85 (n=10,7) | 14.44 # positive cells | Standard Deviation 13.122 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 85 (n=10,6) Change | 2.24 # positive cells | Standard Deviation 13.351 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD3 Dermis lesional Day 140(n=7,4) Change | 6.33 # positive cells | Standard Deviation 20.884 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Epidermis lesional Day 29(n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 85(n=18,8) | 0.44 # positive cells | Standard Deviation 0.36 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 140(n=6,4) Change | -0.73 # positive cells | Standard Deviation 1.473 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epdiermis non lesional Day 85(n=18,8) Change | -0.49 # positive cells | Standard Deviation 0.797 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 140(n=17,7) | 0.76 # positive cells | Standard Deviation 1.355 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis non lesional Day 140(n=16,7) Change | -0.04 # positive cells | Standard Deviation 1.802 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Baseline(n=19,8) | 0.91 # positive cells | Standard Deviation 1.204 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Baseline(n=19,10) | 19.39 # positive cells | Standard Deviation 13.966 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 8(n=19,10) | 16.04 # positive cells | Standard Deviation 10.59 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 85 (n=18,8) | 11.18 # positive cells | Standard Deviation 4.568 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 85 (n=17,8) Change | 0.52 # positive cells | Standard Deviation 3.239 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis non lesional Day 140(n=17,7) | 7.22 # positive cells | Standard Deviation 2.1 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 8(n=11,10) | 8.08 # positive cells | Standard Deviation 2.743 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 8(n=11,8) Change | 1.26 # positive cells | Standard Deviation 2.89 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD117 Dermis lesional Day 29(n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 8(n=18,10) Change | -3.35 # positive cells | Standard Deviation 10.063 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 29(n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 29(n=4,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 85(n=18,8) Change | 19.21 # positive cells | Standard Deviation 10.316 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 85(n=17,8) Change | -2.32 # positive cells | Standard Deviation 9.451 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 140(n=17,7) | 16.90 # positive cells | Standard Deviation 10.151 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis non lesional Day 140(n=16,7) Change | -2.01 # positive cells | Standard Deviation 13.6 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional baseline(n=19,8) | 18.98 # positive cells | Standard Deviation 9.361 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 8(n=11,10) | 17.74 # positive cells | Standard Deviation 9.23 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 8(n=11,8) Change | 0.10 # positive cells | Standard Deviation 10.085 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Dermis lesional Day 29(n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epidermis lesional Day 29(n=5,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD4 Epdiermis lesional Day 29(n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Baseline(n=19,10) | 0.24 # positive cells | Standard Deviation 0.42 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 8(n=19,10) | 0.20 # positive cells | Standard Deviation 0.34 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 8(n=18,10) Change | -0.04 # positive cells | Standard Deviation 0.532 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 29(n=4,0) | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 29(n=4,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 85(n=18,8) | 0.15 # positive cells | Standard Deviation 0.207 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 85(n=17,8) Change | -0.13 # positive cells | Standard Deviation 0.354 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 140(n=17,7) | 0.28 # positive cells | Standard Deviation 0.351 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis non lesional Day 140(n=16,7) Change | -0.01 # positive cells | Standard Deviation 0.566 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Baseline(n=19,8) | 0.14 # positive cells | Standard Deviation 0.207 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 29(n=5,0) Change | NA # positive cells | — |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 85(n=10,7) | 0.03 # positive cells | Standard Deviation 0.076 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 85(n=10,6) Change | -0.15 # positive cells | Standard Deviation 0.235 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 140(n=6,5) | 0.33 # positive cells | Standard Deviation 0.239 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Epidermis lesional Day 140(n=6,4) Change | 0.18 # positive cells | Standard Deviation 0.304 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Baseline(n=19,10) | 6.59 # positive cells | Standard Deviation 3.826 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 8(n=19,10) | 5.50 # positive cells | Standard Deviation 3.779 |
| Placebo IGE025 | Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit | CD8 Dermis non lesional Day 8 (n=18,10) Change | -1.09 # positive cells | Standard Deviation 1.374 |
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.
Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.
Time frame: Baseline through Day 85
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells bound IgE D1 (n=8,8) | 4.53 % out of leukocytes | Standard Deviation 5.001 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Basophils D1 (n=19,10) Units | 0.23 % out of leukocytes | Standard Deviation 0.132 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells bound IgE D85(n=5,7) | 7.32 % out of leukocytes | Standard Deviation 7.579 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells Chge (n=7,7) | 0.31 % out of leukocytes | Standard Deviation 1.377 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells bound IgE chge (n=5,7 | 1.46 % out of leukocytes | Standard Deviation 3.545 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Basophils D85 (n=7,5) Units | 0.47 % out of leukocytes | Standard Deviation 0.215 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells D1 (n=10,9) | 3.57 % out of leukocytes | Standard Deviation 2.298 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells D85 (n=7,7) | 3.84 % out of leukocytes | Standard Deviation 1.595 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Dendritic cells D85 (n=8,5) | 0.37 % out of leukocytes | Standard Deviation 0.231 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Basophils chge (n=7,5) Units | 0.22 % out of leukocytes | Standard Deviation 0.268 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Dendritic cells Chge (n=7,5) | 0.02 % out of leukocytes | Standard Deviation 0.272 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Dendritic cells D1 (n=10,7) | 0.37 % out of leukocytes | Standard Deviation 0.196 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Dendritic cells Chge (n=7,5) | -0.02 % out of leukocytes | Standard Deviation 0.182 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells D85 (n=7,7) | 3.25 % out of leukocytes | Standard Deviation 2.007 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells Chge (n=7,7) | 0.73 % out of leukocytes | Standard Deviation 0.805 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Basophils D1 (n=19,10) Units | 0.36 % out of leukocytes | Standard Deviation 0.482 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Basophils D85 (n=7,5) Units | 0.40 % out of leukocytes | Standard Deviation 0.451 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Basophils chge (n=7,5) Units | -0.06 % out of leukocytes | Standard Deviation 0.176 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells bound IgE D1 (n=8,8) | 15.19 % out of leukocytes | Standard Deviation 22.609 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells bound IgE D85(n=5,7) | 25.66 % out of leukocytes | Standard Deviation 26.485 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells bound IgE chge (n=5,7 | 12.53 % out of leukocytes | Standard Deviation 21.725 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | CD19+ B cells D1 (n=10,9) | 2.5 % out of leukocytes | Standard Deviation 1.247 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Dendritic cells D85 (n=8,5) | 0.27 % out of leukocytes | Standard Deviation 0.21 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes. | Dendritic cells D1 (n=10,7) | 0.24 % out of leukocytes | Standard Deviation 0.14 |
Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.
Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.
Time frame: Baseline through Day 85
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.• FACS parameters: FceRI expression on basophils and IgE bound, FceR2 expression on B cells and IgE bound, and FceRI expression on dendritic cells
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | CD19+ B cells with FcεR2 exp D1 (n=10,9) | 59040 Flourescence units | Standard Deviation 42446 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | CD19+ B cells with FcεR2 exp D85 (n=7,7) | 59429 Flourescence units | Standard Deviation 55980 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with FcεR1 exp D1 (n=11,8) | 292391 Flourescence units | Standard Deviation 135848 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with FcεR1 exp D85 (n=7,5) | 79457 Flourescence units | Standard Deviation 29333 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | CD19+ B cells with FcεR2 exp chge (n=7,7) | 12814 Flourescence units | Standard Deviation 32631 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with FcεR1 expression Chge (n=6,5) | -243700 Flourescence units | Standard Deviation 118883 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with bound IgE D 1 (n=11,7) | 149656 Flourescence units | Standard Deviation 112936 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with bound IgE D85 (n=7,5) | 9554 Flourescence units | Standard Deviation 6214 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with bound IgE Chge (n=6,5) | -178487 Flourescence units | Standard Deviation 103456 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Dendritic cells with FcεR1 expr D1 (n=10,7) | 40880 Flourescence units | Standard Deviation 17191 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Dendritic cells with FcεR1 expr D85 (n=6,5) | 38283 Flourescence units | Standard Deviation 5768 |
| IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Dendritic cells with FcεR1 expr Chge (n=5,5) | -10100 Flourescence units | Standard Deviation 16887 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with bound IgE D 1 (n=11,7) | 236071 Flourescence units | Standard Deviation 89043 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | CD19+ B cells with FcεR2 exp D1 (n=10,9) | 59700 Flourescence units | Standard Deviation 27171 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Dendritic cells with FcεR1 expr Chge (n=5,5) | -516 Flourescence units | Standard Deviation 5925 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with bound IgE D85 (n=7,5) | 212620 Flourescence units | Standard Deviation 109645 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with FcεR1 exp D1 (n=11,8) | 312038 Flourescence units | Standard Deviation 147037 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Dendritic cells with FcεR1 expr D1 (n=10,7) | 43029 Flourescence units | Standard Deviation 12363 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with FcεR1 exp D85 (n=7,5) | 291000 Flourescence units | Standard Deviation 108028 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | CD19+ B cells with FcεR2 exp D85 (n=7,7) | 49243 Flourescence units | Standard Deviation 33460 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with bound IgE Chge (n=6,5) | -12680 Flourescence units | Standard Deviation 59998 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | CD19+ B cells with FcεR2 exp chge (n=7,7) | 3986 Flourescence units | Standard Deviation 16779 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Basophils with FcεR1 expression Chge (n=6,5) | -38260 Flourescence units | Standard Deviation 60085 |
| Placebo IGE025 | Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units. | Dendritic cells with FcεR1 expr D85 (n=6,5) | 36962 Flourescence units | Standard Deviation 18562 |
Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit
Time frame: Baseline through Day 85
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Baseline (n=19,10) | 5.0526 ug/mL | Standard Deviation 2.06757 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 29 (n=20,9) | 2.5869 ug/mL | Standard Deviation 2.31661 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 2 (n=20,10) | 4.1500 ug/mL | Standard Deviation 1.6111 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 2 (n=20,9) | 0.0836 ug/mL | Standard Deviation 0.0663 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 8 (n=20,10) | 4.5000 ug/mL | Standard Deviation 2.01311 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 2 (n=20, 10) | 2.8190 ug/mL | Standard Deviation 2.94786 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 15 (n=19,8) | 4.5789 ug/mL | Standard Deviation 1.6437 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 8 (n=19,8) | 0.0910 ug/mL | Standard Deviation 0.07704 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 29 (n=20,9) | 5.1500 ug/mL | Standard Deviation 2.20705 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 85 (n=17,8) | 2.5178 ug/mL | Standard Deviation 1.93931 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 85 (n=17,8) | 5.8235 ug/mL | Standard Deviation 1.50977 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 15 (n=19,7) | 0.0883 ug/mL | Standard Deviation 0.06303 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 140 (n=18,10) | 4.8333 ug/mL | Standard Deviation 2.64019 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 15 (n=19,8) | 2.2711 ug/mL | Standard Deviation 1.98781 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Baseline (n=19,10) | 0.4858 ug/mL | Standard Deviation 0.09955 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 29 (n=20,9) | 0.0881 ug/mL | Standard Deviation 0.07624 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 2 (n=20,10) | 0.4468 ug/mL | Standard Deviation 0.07872 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 140 (n=18,10) | 2.022 ug/mL | Standard Deviation 2.44218 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 8 (n=20,10) | 0.4967 ug/mL | Standard Deviation 0.12551 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 85 (n=17,8) | 0.0714 ug/mL | Standard Deviation 0.03079 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 15 (n=19,8) | 0.4788 ug/mL | Standard Deviation 0.12577 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 8 (n=20,10) | 2.5597 ug/mL | Standard Deviation 2.22009 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 29 (n=20,9) | 0.4633 ug/mL | Standard Deviation 0.10172 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 140 (n=18,9) | 0.0864 ug/mL | Standard Deviation 0.07319 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 85 ( n= 17,8) | 0.4314 ug/mL | Standard Deviation 0.10424 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Baseline (n=19,10) | 0.1020 ug/mL | Standard Deviation 0.07807 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 140 ( n=15,10) | 0.4314 ug/mL | Standard Deviation 0.10921 |
| IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Baseline (n=19,10) | 2.9669 ug/mL | Standard Deviation 2.31825 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 140 ( n=15,10) | 0.4918 ug/mL | Standard Deviation 0.1525 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Baseline (n=19,10) | 3.0394 ug/mL | Standard Deviation 2.38102 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 2 (n=20, 10) | 3.3035 ug/mL | Standard Deviation 3.52023 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 8 (n=20,10) | 2.2742 ug/mL | Standard Deviation 1.58648 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 15 (n=19,8) | 2.0216 ug/mL | Standard Deviation 1.46346 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 29 (n=20,9) | 2.2826 ug/mL | Standard Deviation 1.56237 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 85 (n=17,8) | 1.8724 ug/mL | Standard Deviation 1.16171 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CCR3 Day 140 (n=18,10) | 2.4060 ug/mL | Standard Deviation 1.85351 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Baseline (n=19,10) | 0.0638 ug/mL | Standard Deviation 0.07208 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 2 (n=20,9) | 0.0621 ug/mL | Standard Deviation 0.06496 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 8 (n=19,8) | 0.0772 ug/mL | Standard Deviation 0.0599 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 15 (n=19,7) | 0.0546 ug/mL | Standard Deviation 0.0255 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 29 (n=20,9) | 0.0601 ug/mL | Standard Deviation 0.04219 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 85 (n=17,8) | 0.0430 ug/mL | Standard Deviation 0.0291 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine CXCR3/IP-10 Day 140 (n=18,9) | 0.0859 ug/mL | Standard Deviation 0.07489 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Baseline (n=19,10) | 5.2000 ug/mL | Standard Deviation 1.13529 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 2 (n=20,10) | 5.0000 ug/mL | Standard Deviation 1.76383 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 8 (n=20,10) | 5.4000 ug/mL | Standard Deviation 2.01108 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 15 (n=19,8) | 4.7500 ug/mL | Standard Deviation 1.83225 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 29 (n=20,9) | 4.7778 ug/mL | Standard Deviation 3.38296 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 85 (n=17,8) | 5.0000 ug/mL | Standard Deviation 1.30931 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Histamine Day 140 (n=18,10) | 5.7000 ug/mL | Standard Deviation 1.76698 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Baseline (n=19,10) | 0.5191 ug/mL | Standard Deviation 0.14846 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 2 (n=20,10) | 0.4975 ug/mL | Standard Deviation 0.14406 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 8 (n=20,10) | 0.4728 ug/mL | Standard Deviation 0.15713 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 15 (n=19,8) | 0.4709 ug/mL | Standard Deviation 0.11789 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 29 (n=20,9) | 0.4704 ug/mL | Standard Deviation 0.11356 |
| Placebo IGE025 | Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit | Chemokine ICAM-1 Day 85 ( n= 17,8) | 0.4037 ug/mL | Standard Deviation 0.05599 |
Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment
Time frame: Day 29 to Day 85
Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IGE025 | Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment | 90.9 Percentage of days | Standard Deviation 22.83 |
| Placebo IGE025 | Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment | 70.5 Percentage of days | Standard Deviation 28.5 |
Serum Levels of Omalizumab
Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks
Time frame: Baseline through Day 85
Population: PK analysis set which included all subjects who received at least one dose of study drug and had evaluable IGE025 concentrations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Serum Levels of Omalizumab | Day 1 | 0.0 ng/mL | Standard Deviation 0 |
| IGE025 | Serum Levels of Omalizumab | Day 2 | 13400 ng/mL | Standard Deviation 4690 |
| IGE025 | Serum Levels of Omalizumab | Day 8 | 30100 ng/mL | Standard Deviation 7800 |
| IGE025 | Serum Levels of Omalizumab | Day 29 | 17000 ng/mL | Standard Deviation 5500 |
| IGE025 | Serum Levels of Omalizumab | Day 57 | 25000 ng/mL | Standard Deviation 8640 |
| IGE025 | Serum Levels of Omalizumab | Day 85 | 28800 ng/mL | Standard Deviation 11400 |
Skindex-29 by Treatment
The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients' quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.
Time frame: Baseline and Day 85
Population: Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Skindex-29 by Treatment | Baseline (n= 16,9) | 17.98 Score | Standard Deviation 7.807 |
| IGE025 | Skindex-29 by Treatment | Day 85 (n=16,8) | 6.17 Score | Standard Deviation 7.119 |
| Placebo IGE025 | Skindex-29 by Treatment | Baseline (n= 16,9) | 21.67 Score | Standard Deviation 9.068 |
| Placebo IGE025 | Skindex-29 by Treatment | Day 85 (n=16,8) | 22.63 Score | Standard Deviation 10.276 |
Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit
Time frame: Baseline through Day 140
Population: All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Common Silver Birch Absolute Change (n = 4,3) | -10.2145 IU/mL | Standard Deviation 26.47094 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Alternaria alternara Baseline (n= 0, 1) | NA IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Artemisia vulgaris (Mugwort) Baseline (n=1,1) | 0.2730 IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Artemisia vulgaris (Mugwort) Day 140( n=0,1) | NA IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Cat dander Basseline (n=3,1) | 17.9677 IU/mL | Standard Deviation 22.73833 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Cat dander Day 140 (n=2,1) | 21.0100 IU/mL | Standard Deviation 26.14881 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Common silver Birch Baseline (n=6,3) | 12.3640 IU/mL | Standard Deviation 19.48667 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Common silver Birch Day 140 (n=4,3) | 4.4890 IU/mL | Standard Deviation 6.15938 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dog dander Baseline (n=2,1) | 26.7720 IU/mL | Standard Deviation 37.09199 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dog dander Day 140 (n=1,1) | 50.1000 IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides farinae Baseline (n=3,1) | 3.3333 IU/mL | Standard Deviation 3.39883 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides farinae Day 140 (n=2,1) | 5.3200 IU/mL | Standard Deviation 0.89095 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides pteronyssinus Baseline (n=5,1) | 2.1250 IU/mL | Standard Deviation 1.46791 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides pteronyssinus Day 140(n=4,1) | 5.2463 IU/mL | Standard Deviation 3.72052 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Grey Alder (t2) Baseline (n=4,3) | 15.7650 IU/mL | Standard Deviation 20.03961 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Grey Alder (t2) Day 140(n=3,3) | 4.4900 IU/mL | Standard Deviation 5.16654 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | German Cockroach Baseline (n=4,2) | 0.8605 IU/mL | Standard Deviation 0.93609 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | German Cockroach Day 140 (n=4,2) | 3.0263 IU/mL | Standard Deviation 2.8719 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Hazelnut Baseline (n=3,3) | 8.9627 IU/mL | Standard Deviation 14.49722 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Hazelnut Day 140 (n=2,3) | 1.4450 IU/mL | Standard Deviation 1.50977 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Olive (black, fresh) Baseline (n=4,1) | 0.0890 IU/mL | Standard Deviation 0.178 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Olive (black, fresh) Day 140 (n=3,1) | 0.1037 IU/mL | Standard Deviation 0.17956 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Platanus acerifolia Baseline (n=1,1) | 0.1210 IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Platanus acerifolia Day 140 (n=0,1) | 0.0000 IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Parietaria judaica Baseline(n=0,1) | 0.0000 IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Parietaria judaica Day 140 (n=0,1) | 0.0000 IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin A Baseline (n=20,10) | 0.7264 IU/mL | Standard Deviation 3.07821 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin A Day 140 (n=18,10) | 1.6161 IU/mL | Standard Deviation 4.39936 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin C Baseline (n=20,10) | 0.8976 IU/mL | Standard Deviation 3.02621 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin C Day 140 (n=18,10) | 2.1089 IU/mL | Standard Deviation 4.19834 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin TSST Baseline (n=20,10) | 0.5390 IU/mL | Standard Deviation 1.02581 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin TSST Day 140 (n=18,10) | 0.8402 IU/mL | Standard Deviation 1.05356 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Alternaria alternara Absolute Change (n = 0,1) | NA IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Artemisia vulgaris Absolute Change (n = 0,1) | NA IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Cat dander Absolute Change (n = 2,1) | -1.1315 IU/mL | Standard Deviation 4.33951 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Alternaria alternara Day 140 (n= 0,1) | NA IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dog dander Absolute Change (n = 1,1) | -2.9000 IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides farinae Absolute Change(n=2,1) | 3.9350 IU/mL | Standard Deviation 1.46371 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides pteronyssinus Abs Chge (n=4,1) | 3.6800 IU/mL | Standard Deviation 3.05938 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Grey Alder Absolute Change(n=3,3) | -12.6300 IU/mL | Standard Deviation 27.47614 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | German Cockroach Absolute Change(n=4,2) | 2.1658 IU/mL | Standard Deviation 2.03436 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Hazelnut Absolute Change(n=2,3) | -11.83000 IU/mL | Standard Deviation 18.1585 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Olive (black, fresh) Absolute Change(n=3,1) | -0.0150 IU/mL | Standard Deviation 0.02598 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Platanus acerifolia Absolute Change(n=0,1) | NA IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Parietaria judaica Absolute Change(n=0,1) | NA IU/mL | — |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin A Abs chge (n=18,10) | 0.8090 IU/mL | Standard Deviation 2.63582 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin C Abs chge (n=18,10) | 1.1116 IU/mL | Standard Deviation 2.26524 |
| IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin TSST Abs chge(n=18,10) | 0.2608 IU/mL | Standard Deviation 0.72963 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Parietaria judaica Absolute Change(n=0,1) | 0.5100 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin C Day 140 (n=18,10) | 0.1922 IU/mL | Standard Deviation 0.28071 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Hazelnut Absolute Change(n=2,3) | 1.6660 IU/mL | Standard Deviation 2.47183 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Platanus acerifolia Day 140 (n=0,1) | 4.8300 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Alternaria alternara Baseline (n= 0, 1) | 0.1360 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Alternaria alternara Day 140 (n= 0,1) | 0.1140 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Common Silver Birch Absolute Change (n = 4,3) | 2.4833 IU/mL | Standard Deviation 5.63479 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Artemisia vulgaris (Mugwort) Baseline (n=1,1) | 1.4800 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Parietaria judaica Baseline(n=0,1) | 1.4900 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Artemisia vulgaris (Mugwort) Day 140( n=0,1) | 1.9100 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin C Abs chge (n=18,10) | 0.0296 IU/mL | Standard Deviation 0.06545 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Cat dander Basseline (n=3,1) | 0.6980 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Parietaria judaica Day 140 (n=0,1) | 2.0000 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Cat dander Day 140 (n=2,1) | 0.8980 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dog dander Absolute Change (n = 1,1) | 0.1570 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Common silver Birch Baseline (n=6,3) | 12.3767 IU/mL | Standard Deviation 11.22609 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin A Baseline (n=20,10) | 0.0741 IU/mL | Standard Deviation 0.1358 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Common silver Birch Day 140 (n=4,3) | 14.8600 IU/mL | Standard Deviation 16.58164 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Olive (black, fresh) Absolute Change(n=3,1) | 0.0000 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dog dander Baseline (n=2,1) | 0.5120 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin A Day 140 (n=18,10) | 0.1077 IU/mL | Standard Deviation 0.15294 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dog dander Day 140 (n=1,1) | 0.6690 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides farinae Absolute Change(n=2,1) | 0.0630 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides farinae Baseline (n=3,1) | 0.4340 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin C Baseline (n=20,10) | 0.1626 IU/mL | Standard Deviation 0.27226 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides farinae Day 140 (n=2,1) | 0.4970 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin A Abs chge (n=18,10) | 0.0336 IU/mL | Standard Deviation 0.09116 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides pteronyssinus Baseline (n=5,1) | 0.4550 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides pteronyssinus Abs Chge (n=4,1) | 0.0620 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Dermatophagoides pteronyssinus Day 140(n=4,1) | 0.5170 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin TSST Baseline (n=20,10) | 0.1537 IU/mL | Standard Deviation 0.23902 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Grey Alder (t2) Baseline (n=4,3) | 10.9533 IU/mL | Standard Deviation 10.92027 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Platanus acerifolia Absolute Change(n=0,1) | 1.1200 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Grey Alder (t2) Day 140(n=3,3) | 13.0533 IU/mL | Standard Deviation 15.24029 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin TSST Day 140 (n=18,10) | 0.1468 IU/mL | Standard Deviation 0.22155 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | German Cockroach Baseline (n=4,2) | 0.4425 IU/mL | Standard Deviation 0.62579 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Grey Alder Absolute Change(n=3,3) | 2.1000 IU/mL | Standard Deviation 4.509 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | German Cockroach Day 140 (n=4,2) | 0.4705 IU/mL | Standard Deviation 0.66539 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Alternaria alternara Absolute Change (n = 0,1) | -0.0220 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Hazelnut Baseline (n=3,3) | 7.3267 IU/mL | Standard Deviation 8.2816 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Staphylococcal enterotoxin TSST Abs chge(n=18,10) | -0.0069 IU/mL | Standard Deviation 0.15669 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Hazelnut Day 140 (n=2,3) | 8.9927 IU/mL | Standard Deviation 10.59244 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Artemisia vulgaris Absolute Change (n = 0,1) | 0.4300 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Olive (black, fresh) Baseline (n=4,1) | 0.0000 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | German Cockroach Absolute Change(n=4,2) | 0.0280 IU/mL | Standard Deviation 0.0396 |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Olive (black, fresh) Day 140 (n=3,1) | 0.0000 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Cat dander Absolute Change (n = 2,1) | 0.2000 IU/mL | — |
| Placebo IGE025 | Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit | Platanus acerifolia Baseline (n=1,1) | 3.7100 IU/mL | — |