Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, SUN13834
Brief summary
The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.
Interventions
DRUGSUN13834
Low dose, orally 3 times a day (tid) for 28 days of SUN13834
DRUGPlacebo
Placebo, orally (tid) for 28 days of SUN13834
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participants between 18 and 65 years of age. * A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria * At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at Screening and prior to randomization (as per Amendment 2 and 3). Under the original protocol and Amendment 1, no minimum EASI score was required.
Exclusion criteria
* Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed). * Use of phototherapy or tanning beds within 6 weeks of screening * History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years. * Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with the interpretation of data from this patient (eg, renal impairment with non-atopic pruritus).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pre-dose | Eczema Area and Severity Index (EASI) Score is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The total EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). Investigator's Global Assessment (IGA) score consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). Higher scores indicate a worse outcome and lower scores indicate a better outcome for all scales. |
| Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. | EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome. |
| Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. | EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. | Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores. |
| Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. | The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores. |
| Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. | IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). |
| Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose. | Mean concentrations of SUN13834 metabolites M-3, M-5, M-6, M-6G, MG-1, and MG-2 in participant plasma samples were measured. |
| Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Baseline up to Week 8 post-dose, up to a total of 36 weeks. | Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition. |
| Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose. | — |
| Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. | IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). |
| Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose. | Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores. |
Countries
United States
Participant flow
Recruitment details
A total of 270 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 27 clinic sites in the United States of America (USA).
Pre-assignment details
Washout period for Atopic Dermatitis treatments such as topical corticosteroids, antihistamines, over the counter (OTC) sleep aids, and some FDA approved devices for 3 months up to 1 week prior to screening and for the duration of the study (including follow-up). After the initiation of the study, the protocol was amended to discontinue group 3 (200 mg three times a day \[tid\]). The efficacy outcomes and analyses were also redefined to compare the 50 mg tid group against the placebo group.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days. | 120 |
| SUN13834 50 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg;(2×50 mg) orally tid for 28 days. | 119 |
| SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) orally tid for 28 days. | 30 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 6 | 1 |
| Overall Study | Lack of compliance | 0 | 2 | 0 |
| Overall Study | Lack of Efficacy | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 3 | 4 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 0 |
| Overall Study | Sponsor decision | 1 | 0 | 10 |
| Overall Study | Withdrew consent | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | SUN13834 200 mg Tid | SUN13834 50 mg Tid |
|---|---|---|---|---|
| Age, Continuous | 37.2 years STANDARD_DEVIATION 13.14 | 37.8 years STANDARD_DEVIATION 12.77 | 37.0 years STANDARD_DEVIATION 10.62 | 38.5 years STANDARD_DEVIATION 12.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 23 Participants | 0 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants | 246 Participants | 30 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 105 Participants | 9 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 71 Participants | 157 Participants | 21 Participants | 65 Participants |
| Region of Enrollment United States | 120 participants | 269 participants | 30 participants | 119 participants |
| Sex: Female, Male Female | 72 Participants | 154 Participants | 22 Participants | 60 Participants |
| Sex: Female, Male Male | 48 Participants | 115 Participants | 8 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 120 | 0 / 30 |
| other Total, other adverse events | 46 / 120 | 44 / 120 | 11 / 30 |
| serious Total, serious adverse events | 3 / 120 | 0 / 120 | 0 / 30 |
Outcome results
Primary
Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Eczema Area and Severity Index (EASI) Score is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The total EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). Investigator's Global Assessment (IGA) score consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). Higher scores indicate a worse outcome and lower scores indicate a better outcome for all scales.
Time frame: Pre-dose
Population: Baseline disease characteristics were assessed using the Intent-to-Treat (ITT) population. All enrolled participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Eczema Area and Severity Index (EASI) Score | 12.59 score on a scale | Standard Deviation 10.02 |
| Placebo | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Investigator's Global Assessment (IGA) Score | 3.0 score on a scale | Standard Deviation 0.67 |
| Placebo | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Insomnia Score | 3.2 score on a scale | Standard Deviation 3.16 |
| Placebo | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pruritus Score | 2.2 score on a scale | Standard Deviation 0.74 |
| SUN13834 50 mg Tid | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Eczema Area and Severity Index (EASI) Score | 12.45 score on a scale | Standard Deviation 8.75 |
| SUN13834 50 mg Tid | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pruritus Score | 2.2 score on a scale | Standard Deviation 0.72 |
| SUN13834 50 mg Tid | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Insomnia Score | 4.0 score on a scale | Standard Deviation 3.06 |
| SUN13834 50 mg Tid | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Investigator's Global Assessment (IGA) Score | 3.1 score on a scale | Standard Deviation 0.69 |
| SUN13834 200 mg Tid | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pruritus Score | 1.9 score on a scale | Standard Deviation 0.8 |
| SUN13834 200 mg Tid | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Investigator's Global Assessment (IGA) Score | 2.6 score on a scale | Standard Deviation 0.93 |
| SUN13834 200 mg Tid | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Insomnia Score | 3.0 score on a scale | Standard Deviation 3.07 |
| SUN13834 200 mg Tid | Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Eczema Area and Severity Index (EASI) Score | 6.01 score on a scale | Standard Deviation 5.98 |
Primary
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: EASI was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -1.94 units on a scale | Standard Deviation 5.08 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -3.28 units on a scale | Standard Deviation 5.27 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -5.38 units on a scale | Standard Deviation 7.2 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -4.26 units on a scale | Standard Deviation 6.91 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -5.09 units on a scale | Standard Deviation 7.24 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -5.26 units on a scale | Standard Deviation 7.55 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -8.49 units on a scale | Standard Deviation 7.89 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -7.08 units on a scale | Standard Deviation 6.81 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -8.19 units on a scale | Standard Deviation 6.9 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -7.99 units on a scale | Standard Deviation 8.29 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -5.13 units on a scale | Standard Deviation 4.95 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -2.36 units on a scale | Standard Deviation 3.73 |
Comparison: Change from Baseline to Day 8p-value: 0.533ANCOVA
Comparison: Change from Baseline to Day 15p-value: 0.009ANCOVA
Comparison: Change from Baseline to Day 22p-value: 0.002ANCOVA
Comparison: Change from Baseline to Day 29p-value: 0.003ANCOVA
Primary
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: EASI score was assessed using the Intent-to-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -4.64 units on a scale | Standard Deviation 6.7 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -4.41 units on a scale | Standard Deviation 6.95 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -4.70 units on a scale | Standard Deviation 6.96 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -1.66 units on a scale | Standard Deviation 4.59 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -3.83 units on a scale | Standard Deviation 6.3 |
| Placebo | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -2.88 units on a scale | Standard Deviation 4.82 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -6.41 units on a scale | Standard Deviation 7.86 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -4.06 units on a scale | Standard Deviation 4.92 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -5.67 units on a scale | Standard Deviation 6.6 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -6.70 units on a scale | Standard Deviation 6.82 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -6.73 units on a scale | Standard Deviation 7.77 |
| SUN13834 50 mg Tid | Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -1.94 units on a scale | Standard Deviation 3.36 |
Comparison: Change from Baseline to Day 8p-value: 0.519ANCOVA
Comparison: Change from Baseline to Day 15p-value: 0.032ANCOVA
Comparison: Change from Baseline to Day 22p-value: 0.008ANCOVA
Comparison: Change from Baseline to Day 29p-value: 0.006ANCOVA
Primary
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: EASI score was assessed using the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -13.65 percent change | Standard Deviation 29.51 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -23.67 percent change | Standard Deviation 31.94 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -37.58 percent change | Standard Deviation 46.18 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -40.69 percent change | Standard Deviation 46.07 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -40.16 percent change | Standard Deviation 47.42 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -29.29 percent change | Standard Deviation 45.21 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -50.86 percent change | Standard Deviation 42.5 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -16.03 percent change | Standard Deviation 23.94 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -44.40 percent change | Standard Deviation 35.29 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -33.64 percent change | Standard Deviation 31.26 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -54.35 percent change | Standard Deviation 40.4 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -52.84 percent change | Standard Deviation 35.9 |
Primary
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: EASI score was assessed using the Intent-to-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -12.62 percent change | Standard Deviation 30.45 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -30.83 percent change | Standard Deviation 42.61 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -38.33 percent change | Standard Deviation 43.89 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -37.29 percent change | Standard Deviation 56.64 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -37.89 percent change | Standard Deviation 53.35 |
| Placebo | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -23.42 percent change | Standard Deviation 33.34 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -48.06 percent change | Standard Deviation 44.46 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -15.52 percent change | Standard Deviation 27.03 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -45.35 percent change | Standard Deviation 45.55 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -39.11 percent change | Standard Deviation 42.83 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -28.46 percent change | Standard Deviation 59.41 |
| SUN13834 50 mg Tid | Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -47.46 percent change | Standard Deviation 39.89 |
Secondary
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: Insomnia score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.6 units on a scale | Standard Deviation 2.41 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.7 units on a scale | Standard Deviation 2.2 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.6 units on a scale | Standard Deviation 2.25 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -0.8 units on a scale | Standard Deviation 2.44 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -0.9 units on a scale | Standard Deviation 2.5 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -0.6 units on a scale | Standard Deviation 2.56 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -1.0 units on a scale | Standard Deviation 3.09 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.7 units on a scale | Standard Deviation 2.78 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -1.5 units on a scale | Standard Deviation 2.96 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -1.3 units on a scale | Standard Deviation 2.66 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -1.3 units on a scale | Standard Deviation 3.17 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -1.4 units on a scale | Standard Deviation 2.93 |
Secondary
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: Insomnia score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -0.9 units on a scale | Standard Deviation 2.55 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -0.8 units on a scale | Standard Deviation 2.88 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.8 units on a scale | Standard Deviation 2.48 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.6 units on a scale | Standard Deviation 2.5 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -0.9 units on a scale | Standard Deviation 2.77 |
| Placebo | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.7 units on a scale | Standard Deviation 2.5 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -1.3 units on a scale | Standard Deviation 2.96 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -1.2 units on a scale | Standard Deviation 2.69 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -1.4 units on a scale | Standard Deviation 3.01 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -1.1 units on a scale | Standard Deviation 3.12 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -1.3 units on a scale | Standard Deviation 3.24 |
| SUN13834 50 mg Tid | Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.7 units on a scale | Standard Deviation 2.61 |
Secondary
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: IGA Score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.2 units on a scale | Standard Deviation 0.54 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.4 units on a scale | Standard Deviation 0.69 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.6 units on a scale | Standard Deviation 0.77 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -0.8 units on a scale | Standard Deviation 0.97 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -0.8 units on a scale | Standard Deviation 1.01 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -0.8 units on a scale | Standard Deviation 1.1 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -1.1 units on a scale | Standard Deviation 1.05 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.3 units on a scale | Standard Deviation 0.57 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -1.1 units on a scale | Standard Deviation 1 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.6 units on a scale | Standard Deviation 0.74 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -1.1 units on a scale | Standard Deviation 1.04 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.9 units on a scale | Standard Deviation 0.87 |
Secondary
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: IGA Score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.2 units on a scale | Standard Deviation 0.54 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -0.8 units on a scale | Standard Deviation 1.02 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.4 units on a scale | Standard Deviation 0.66 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.5 units on a scale | Standard Deviation 0.8 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -0.8 units on a scale | Standard Deviation 1.13 |
| Placebo | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -0.8 units on a scale | Standard Deviation 1.05 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -1.2 units on a scale | Standard Deviation 1.05 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -1.0 units on a scale | Standard Deviation 0.83 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -1.2 units on a scale | Standard Deviation 0.98 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.2 units on a scale | Standard Deviation 0.58 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -1.2 units on a scale | Standard Deviation 1.04 |
| SUN13834 50 mg Tid | Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.7 units on a scale | Standard Deviation 0.69 |
Secondary
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: Pruritus score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.3 units on a scale | Standard Deviation 0.77 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.5 units on a scale | Standard Deviation 0.83 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.6 units on a scale | Standard Deviation 0.92 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -0.7 units on a scale | Standard Deviation 0.85 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -0.6 units on a scale | Standard Deviation 1.04 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -0.6 units on a scale | Standard Deviation 0.93 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -0.8 units on a scale | Standard Deviation 1.09 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.3 units on a scale | Standard Deviation 0.88 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -0.9 units on a scale | Standard Deviation 1.04 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.6 units on a scale | Standard Deviation 0.92 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -0.7 units on a scale | Standard Deviation 1.09 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.7 units on a scale | Standard Deviation 1.04 |
Secondary
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: Pruritus score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.6 units on a scale | Standard Deviation 0.91 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -0.7 units on a scale | Standard Deviation 0.89 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.3 units on a scale | Standard Deviation 0.72 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.5 units on a scale | Standard Deviation 0.8 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -0.6 units on a scale | Standard Deviation 1.06 |
| Placebo | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -0.6 units on a scale | Standard Deviation 0.91 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: Change from Baseline | -0.7 units on a scale | Standard Deviation 1.16 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: Change from Baseline | -0.7 units on a scale | Standard Deviation 1.1 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: Change from Baseline | -0.7 units on a scale | Standard Deviation 0.95 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: Change from Baseline | -0.9 units on a scale | Standard Deviation 1.13 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: Change from Baseline | -0.3 units on a scale | Standard Deviation 0.87 |
| SUN13834 50 mg Tid | Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: Change from Baseline | -0.7 units on a scale | Standard Deviation 1.14 |
Secondary
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Mean concentrations of SUN13834 metabolites M-3, M-5, M-6, M-6G, MG-1, and MG-2 in participant plasma samples were measured.
Time frame: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
Population: Mean of SUN13834 metabolite plasma concentrations were assessed using the Pharmacokinetic-Intent-to-Treat (PK-ITT) population, those with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3: 2.5-5.0 h | 8.01 ng/mL | Standard Deviation 6.27 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3:5.0-10 h | 4.36 ng/mL | Standard Deviation 5.1 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5:5.0-10 h | 13.0 ng/mL | Standard Deviation 11.7 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5: 8-24 h | 8.91 ng/mL | Standard Deviation 18 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6: Predose | 0.500 ng/mL | — |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6:5.0-10 h | 26.6 ng/mL | Standard Deviation 19.6 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6: 8-24 h | 16.9 ng/mL | Standard Deviation 43.8 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G: Predose | 0.00 ng/mL | — |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G: 0-2.5 h | 15.3 ng/mL | Standard Deviation 22.8 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G: 2.5-5.0 h | 18.9 ng/mL | Standard Deviation 22.3 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1: 8-24 h | 3.25 ng/mL | Standard Deviation 9.36 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2: Predose | 0.0038 ng/mL | Standard Deviation 0.039 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2: 0-2.5 h | 1.31 ng/mL | Standard Deviation 2.84 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3: Predose | 0.500 ng/mL | — |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3: 0-2.5 h | 7.59 ng/mL | Standard Deviation 8.77 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3: 8-24 h | 2.33 ng/mL | Standard Deviation 6.79 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5: Predose | 0.513 ng/mL | Standard Deviation 0.132 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5: 0-2.5 h | 16.8 ng/mL | Standard Deviation 17.3 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5: 2.5-5.0 h | 17.0 ng/mL | Standard Deviation 13 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6: 0-2.5 h | 26.8 ng/mL | Standard Deviation 26.8 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6: 2.5-5.0 h | 31.6 ng/mL | Standard Deviation 21.5 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G:5.0-10 h | 16.2 ng/mL | Standard Deviation 17.9 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G: 8-24 h | 12.6 ng/mL | Standard Deviation 25.7 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1: Predose | 0.0379 ng/mL | Standard Deviation 0.392 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1: 0-2.5 h | 12.0 ng/mL | Standard Deviation 17.4 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1: 2.5-5.0 h | 12.0 ng/mL | Standard Deviation 11.9 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1:5.0-10 h | 8.51 ng/mL | Standard Deviation 10.7 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2: 2.5-5.0 h | 1.81 ng/mL | Standard Deviation 3.58 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2:5.0-10 h | 1.42 ng/mL | Standard Deviation 3.4 |
| Placebo | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2: 8-24 h | 1.44 ng/mL | Standard Deviation 3.57 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3:5.0-10 h | 13.2 ng/mL | Standard Deviation 14.4 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3: 2.5-5.0 h | 41.7 ng/mL | Standard Deviation 28.4 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1: 2.5-5.0 h | 50.0 ng/mL | Standard Deviation 67.1 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5: 2.5-5.0 h | 68.1 ng/mL | Standard Deviation 70.9 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3: 8-24 h | 6.11 ng/mL | Standard Deviation 10 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5:5.0-10 h | 33.3 ng/mL | Standard Deviation 19.6 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G: 8-24 h | 34.1 ng/mL | Standard Deviation 55.1 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5: 8-24 h | 16.8 ng/mL | Standard Deviation 17.4 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5: Predose | 0.500 ng/mL | — |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6: Predose | 0.500 ng/mL | — |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2: 2.5-5.0 h | 6.98 ng/mL | Standard Deviation 11.6 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6:5.0-10 h | 65.7 ng/mL | Standard Deviation 50.9 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-5: 0-2.5 h | 76.9 ng/mL | Standard Deviation 122 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6: 8-24 h | 50.0 ng/mL | Standard Deviation 79.1 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1: Predose | 0.00 ng/mL | — |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G: Predose | 0.00 ng/mL | — |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2: 0-2.5 h | 1.78 ng/mL | Standard Deviation 3.7 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G: 0-2.5 h | 26.1 ng/mL | Standard Deviation 41.3 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6: 0-2.5 h | 69.5 ng/mL | Standard Deviation 83.7 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1:5.0-10 h | 22.0 ng/mL | Standard Deviation 21.4 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1: 0-2.5 h | 17.1 ng/mL | Standard Deviation 37.4 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-1: 8-24 h | 7.24 ng/mL | Standard Deviation 10.1 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6: 2.5-5.0 h | 96.6 ng/mL | Standard Deviation 67.4 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2: Predose | 0.00 ng/mL | — |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G: 2.5-5.0 h | 85.3 ng/mL | Standard Deviation 63.6 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2: 8-24 h | 1.60 ng/mL | Standard Deviation 1.69 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | MG-2:5.0-10 h | 4.93 ng/mL | Standard Deviation 8.26 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3: Predose | 0.500 ng/mL | — |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-6G:5.0-10 h | 54.4 ng/mL | Standard Deviation 61.8 |
| SUN13834 50 mg Tid | Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | M-3: 0-2.5 h | 32.9 ng/mL | Standard Deviation 48.4 |
Secondary
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
Population: Mean of SUN13834 Plasma Concentrations were assessed from the Pharmacokinetic-Efficacy Evaluable (PK-EE) population, those with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 0-2.5 h | 93.7 ng/mL | Standard Deviation 122 |
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 5.0-10 h | 50.5 ng/mL | Standard Deviation 78.5 |
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 2.5-5.0 h | 87.7 ng/mL | Standard Deviation 86.7 |
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 8-24 h | 18.2 ng/mL | Standard Deviation 51.7 |
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Predose | 0.747 ng/mL | Standard Deviation 5.68 |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 8-24 h | 11.3 ng/mL | Standard Deviation 4.47 |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Predose | 0.100 ng/mL | — |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 0-2.5 h | 741 ng/mL | Standard Deviation 1090 |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 2.5-5.0 h | 508 ng/mL | Standard Deviation 270 |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 5.0-10 h | 103 ng/mL | Standard Deviation 76.4 |
Secondary
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
Population: Mean of SUN13834 Plasma Concentrations were assessed from the Pharmacokinetic-Intent-to-Treat (PK-ITT) population, those with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Predose | 0.565 ng/mL | Standard Deviation 4.81 |
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 0-2.5 h | 99.8 ng/mL | Standard Deviation 119 |
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 2.5-5.0 h | 90.6 ng/mL | Standard Deviation 86.7 |
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 5.0-10 h | 49.4 ng/mL | Standard Deviation 69.8 |
| Placebo | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 8-24 h | 27.2 ng/mL | Standard Deviation 98.1 |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 8-24 h | 29.2 ng/mL | Standard Deviation 34 |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Predose | 0.100 ng/mL | — |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 2.5-5.0 h | 367 ng/mL | Standard Deviation 237 |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 0-2.5 h | 452 ng/mL | Standard Deviation 691 |
| SUN13834 50 mg Tid | Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | 5.0-10 h | 120 ng/mL | Standard Deviation 122 |
Secondary
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: IGA Score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -23.64 percent change | Standard Deviation 33.88 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -11.09 percent change | Standard Deviation 21.72 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -16.02 percent change | Standard Deviation 26.71 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -25.18 percent change | Standard Deviation 35.21 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -7.06 percent change | Standard Deviation 17.76 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -25.72 percent change | Standard Deviation 37.31 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -7.33 percent change | Standard Deviation 17.38 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -30.47 percent change | Standard Deviation 24.68 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -37.43 percent change | Standard Deviation 34.26 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -20.23 percent change | Standard Deviation 20.93 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -37.99 percent change | Standard Deviation 29.96 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -36.51 percent change | Standard Deviation 32.98 |
Secondary
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: IGA Score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -6.10 percent change | Standard Deviation 18.51 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -10.84 percent change | Standard Deviation 23 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -17.95 percent change | Standard Deviation 26.13 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -24.21 percent change | Standard Deviation 32.24 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -25.91 percent change | Standard Deviation 34.47 |
| Placebo | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -27.24 percent change | Standard Deviation 37.59 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -34.48 percent change | Standard Deviation 36.66 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -8.83 percent change | Standard Deviation 18.17 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -34.93 percent change | Standard Deviation 34.42 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -19.99 percent change | Standard Deviation 32.34 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -34.10 percent change | Standard Deviation 36.67 |
| SUN13834 50 mg Tid | Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -28.89 percent change | Standard Deviation 30.57 |
Secondary
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: Pruritus score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -1.54 percent change | Standard Deviation 99.05 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -11.53 percent change | Standard Deviation 101.25 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -13.89 percent change | Standard Deviation 104.86 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -18.75 percent change | Standard Deviation 103.37 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -11.95 percent change | Standard Deviation 109.12 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -15.14 percent change | Standard Deviation 106.67 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -28.11 percent change | Standard Deviation 55.8 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change from Baseline | -7.68 percent change | Standard Deviation 48.73 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -33.34 percent change | Standard Deviation 51.94 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -22.22 percent change | Standard Deviation 48.74 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -27.82 percent change | Standard Deviation 53.91 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -25.99 percent change | Standard Deviation 54.76 |
Secondary
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Population: Pruritus score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change in Baseline | -10.03 percent change | Standard Deviation 31.19 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -20.25 percent change | Standard Deviation 44.7 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -21.69 percent change | Standard Deviation 55.6 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -17.92 percent change | Standard Deviation 38.01 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -22.76 percent change | Standard Deviation 46.81 |
| Placebo | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -24.73 percent change | Standard Deviation 45.75 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 4: % Change from Baseline | -22.41 percent change | Standard Deviation 54.15 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 29: % Change from Baseline | -33.34 percent change | Standard Deviation 56.78 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 8: % Change in Baseline | -7.45 percent change | Standard Deviation 44.81 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 15: % Change from Baseline | -23.45 percent change | Standard Deviation 50.45 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Day 22: % Change from Baseline | -22.61 percent change | Standard Deviation 57.74 |
| SUN13834 50 mg Tid | Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Follow-up Week 2: % Change from Baseline | -24.72 percent change | Standard Deviation 57.34 |
Secondary
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Time frame: Baseline up to Week 8 post-dose, up to a total of 36 weeks.
Population: Treatment-emergent adverse events were assessed using the Safety population. All enrolled participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Nasopharyngitis | 9 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pregnancy | 1 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Joint injury | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood pressure increased | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Carbuncle | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Fatigue | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Paresthesia | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Bronchitis | 1 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pulmonary Congestion | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Dermatitis atopic | 3 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pneumonia | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Oropharyngeal pain | 3 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pruritus | 2 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Headache | 11 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Rash | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Cyst drainage | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Sinusitis | 4 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Nausea | 5 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Seasonal allergy | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Upper respiratory tract infection | 12 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Influenza | 3 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Number of participants with at least 1 Adverse Event | 82 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Urinary tract infection | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood IgE increased | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Paranoia | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Vomiting | 3 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Diarrhea | 2 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Accelerated hypertension | 0 Participants |
| Placebo | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood creatine phosphokinase increased | 6 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Paranoia | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Number of participants with at least 1 Adverse Event | 68 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Carbuncle | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Influenza | 1 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Nasopharyngitis | 11 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pneumonia | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Sinusitis | 2 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Upper respiratory tract infection | 8 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Urinary tract infection | 1 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Vomiting | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood creatine phosphokinase increased | 5 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood pressure increased | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Paresthesia | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Dermatitis atopic | 2 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pruritus | 2 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Rash | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Oropharyngeal pain | 1 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pulmonary Congestion | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Fatigue | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Joint injury | 1 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pregnancy | 4 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Accelerated hypertension | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Seasonal allergy | 1 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Cyst drainage | 0 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Bronchitis | 2 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Diarrhea | 6 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Nausea | 6 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood IgE increased | 1 Participants |
| SUN13834 50 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Headache | 5 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Joint injury | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood creatine phosphokinase increased | 0 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Diarrhea | 2 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pregnancy | 0 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Vomiting | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Carbuncle | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Accelerated hypertension | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Urinary tract infection | 2 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Upper respiratory tract infection | 0 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Paranoia | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Sinusitis | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Number of participants with at least 1 Adverse Event | 14 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Seasonal allergy | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pneumonia | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Nausea | 0 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pruritus | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Cyst drainage | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Rash | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Dermatitis atopic | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Nasopharyngitis | 2 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Oropharyngeal pain | 0 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Paresthesia | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Bronchitis | 2 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Pulmonary Congestion | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood pressure increased | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Influenza | 0 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Fatigue | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Blood IgE increased | 1 Participants |
| SUN13834 200 mg Tid | Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis | Headache | 3 Participants |