CHRONIC SPONTANEOUS URTICARIA
Conditions
Keywords
CHRONIC SPONTANEOUS URTICARIA, OMALIZUMAB, URTICARIA CONTROL TEST, IGE025
Brief summary
Evaluate the proportion of patients with an urticaria control test \[UCT\] score of greater than or equal to 12 at Week 12.
Interventions
DRUGOMALIZUMAB
sub cutaneous injections of 300 mg every 4 weeks until Week 8.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged between 18 and 75 years. * Diagnosis of CSU for ≥ 6 months and an inadequate response to nsH1 antihistamines at the time of the request, as defined by the following: * The presence of itch and hives for \> 6 consecutive weeks at any time prior to enrollment, despite current use of H1 antihistamine therapy during this time period. * Weekly UAS7 score (range 0 to 42) 16 and UCT score (range 0 to 16) \< 8 prior to enrollment (Day 1) * Current use of an H1 antihistamine for CSU on the day of the initial visit and Day * Informed consent
Exclusion criteria
* Treatment with an investigational agent within 30 days before enrollment. * Routine (daily or every other day during 5 or more consecutive days) doses of the following medications within 30 days prior to Day -7: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide. * Intravenous (i.v.) immunoglobulin G or plasmapheresis within 30 days prior to Day -7 * Regular (daily/every other day) doxepin (oral) use within 14 days prior to Day -7. * Any H2 antihistamine use within 7 days prior to Day -7. * Any leukotriene receptor antagonist (LTRA) (montelukast or zafirlukast) within 7 days prior to Day 7. * Concomitant use of cyclosporine or any other immunosuppressive agent. * Hypersensitivity to omalizumab or any component of the formulation. * History of anaphylactic shock.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 | WEEK 12 | Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12 The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema | baseline and week 12 | A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease. Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42). |
| Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 | baseline and week 12 | The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12. The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease. A score of ≥12 indicates well-controlled urticaria. |
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema | week 16 | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. |
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema | week 20 | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. |
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema | week 24 | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control |
| Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema | WEEK 12 | 2 patients with angioedema status were missing at baseline and not included |
| The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire | baseline and week 12 | The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12. The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life. |
| The Angioedema Quality of Life (AE-QoL) | baseline and week 12 | The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients. The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment |
| The Dermatology Life Quality Index (DLQI) | baseline and week 12 | The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). |
| Angioedema Activity Using the Angioedema Activity Score (AAS) | baseline and week 12 | The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity. |
| Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema | week 28 | The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control. |
Countries
France
Participant flow
Recruitment details
Full Analysis Set
Participants by arm
| Arm | Count |
|---|---|
| OMALIZUMAB sub cutaneous injections of 300 mg every 4 weeks until Week 8 | 136 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | OMALIZUMAB |
|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 12.67 |
| Sex: Female, Male Female | 106 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 136 |
| serious Total, serious adverse events | 9 / 136 |
Outcome results
Primary
Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12
Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12 The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
Time frame: WEEK 12
Population: (Full analysis set, LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12 | 75.0 percent of participants |
Secondary
Angioedema Activity Using the Angioedema Activity Score (AAS)
The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity.
Time frame: baseline and week 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | Angioedema Activity Using the Angioedema Activity Score (AAS) | baseline | 32.7 scores on a scale | Standard Deviation 27.21 |
| OMALIZUMAB With ANGIOEDEMA | Angioedema Activity Using the Angioedema Activity Score (AAS) | at week 12 | 3.7 scores on a scale | Standard Deviation 10.4 |
Secondary
Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
Time frame: week 16
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema | 14.2 scores on a scale | Standard Deviation 2.96 |
| OMALIZUMAB Without Angioedema | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema | 13.4 scores on a scale | Standard Deviation 3.4 |
Secondary
Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
Time frame: week 20
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema | 14.4 scores on a scale | Standard Deviation 2.4 |
| OMALIZUMAB Without Angioedema | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema | 13.3 scores on a scale | Standard Deviation 4.11 |
Secondary
Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control
Time frame: week 24
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema | 14.5 scores on a scale | Standard Deviation 2.14 |
| OMALIZUMAB Without Angioedema | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema | 13.4 scores on a scale | Standard Deviation 3.75 |
Secondary
Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
Time frame: week 28
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema | 13.5 scores on a scale | Standard Deviation 3.54 |
| OMALIZUMAB Without Angioedema | Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema | 12.0 scores on a scale | Standard Deviation 5.66 |
Secondary
CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema
A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease. Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42).
Time frame: baseline and week 12
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema | baseline | 29.7 scores on a scale | Standard Deviation 7.32 |
| OMALIZUMAB With ANGIOEDEMA | CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema | at week 12 | 6.6 scores on a scale | Standard Deviation 10.08 |
| OMALIZUMAB Without Angioedema | CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema | baseline | 29.2 scores on a scale | Standard Deviation 6.72 |
| OMALIZUMAB Without Angioedema | CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema | at week 12 | 6.5 scores on a scale | Standard Deviation 9.11 |
Secondary
Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema
2 patients with angioedema status were missing at baseline and not included
Time frame: WEEK 12
Population: Full Analysis Set~2 patients with angioedema status missing at baseline were not included so that FAS = 83 + 51 + 2= 136
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema | 69.6 percent of participants |
| OMALIZUMAB Without Angioedema | Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema | 63.8 percent of participants |
Secondary
The Angioedema Quality of Life (AE-QoL)
The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients. The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment
Time frame: baseline and week 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | The Angioedema Quality of Life (AE-QoL) | at week 12 | 16.40 scores on a scale | Standard Deviation 20.074 |
| OMALIZUMAB With ANGIOEDEMA | The Angioedema Quality of Life (AE-QoL) | baseline | 57.88 scores on a scale | Standard Deviation 22.474 |
Secondary
The Dermatology Life Quality Index (DLQI)
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Time frame: baseline and week 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | The Dermatology Life Quality Index (DLQI) | baseline | 14.2 scores on a scale | Standard Deviation 5.39 |
| OMALIZUMAB With ANGIOEDEMA | The Dermatology Life Quality Index (DLQI) | at week 12 | 2.4 scores on a scale | Standard Deviation 3.95 |
| OMALIZUMAB Without Angioedema | The Dermatology Life Quality Index (DLQI) | baseline | 13.2 scores on a scale | Standard Deviation 6.67 |
| OMALIZUMAB Without Angioedema | The Dermatology Life Quality Index (DLQI) | at week 12 | 2.7 scores on a scale | Standard Deviation 5.12 |
Secondary
The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire
The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12. The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life.
Time frame: baseline and week 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire | baseline | 68.9 scores on a scale | Standard Deviation 15.64 |
| OMALIZUMAB With ANGIOEDEMA | The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire | at 12 weeks | 32.5 scores on a scale | Standard Deviation 13.33 |
| OMALIZUMAB Without Angioedema | The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire | baseline | 62.4 scores on a scale | Standard Deviation 17.76 |
| OMALIZUMAB Without Angioedema | The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire | at 12 weeks | 33.3 scores on a scale | Standard Deviation 13.32 |
Secondary
Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12
The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12. The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease. A score of ≥12 indicates well-controlled urticaria.
Time frame: baseline and week 12
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OMALIZUMAB With ANGIOEDEMA | Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 | baseline | 3.0 scores on a scale | Standard Deviation 2.06 |
| OMALIZUMAB With ANGIOEDEMA | Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 | at week 12 | 13.1 scores on a scale | Standard Deviation 3.95 |
| OMALIZUMAB Without Angioedema | Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 | baseline | 3.6 scores on a scale | Standard Deviation 2.55 |
| OMALIZUMAB Without Angioedema | Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12 | at week 12 | 12.9 scores on a scale | Standard Deviation 3.97 |