Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03328897 | Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria | PHASE3 | COMPLETED | 418 | — | — | Apr 26, 2017 | Sep 24, 2019 | Nov 4, 2020 | 27 | China |
| NCT02161562 | OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients | PHASE3 | COMPLETED | 314 | — | — | Aug 1, 2014 | Nov 3, 2016 | Sep 13, 2018 | 35 | Argentina, Brazil +6 |
| NCT01723072 | Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy | PHASE3 | COMPLETED | 91 | — | — | Jan 23, 2013 | May 9, 2014 | Sep 9, 2020 | 25 | Germany |
The severity of the itch was recorded by the patient twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). Baseline ISS7 was calculated 7 days prior to the first treatment date. A weekly score (ISS7) was derived by adding up the average daily scores of the seven days preceding the visit. The possible range of the weekly score was therefore 0 to 21, where 0 is the best score and 21 is the worst score. The complete itch response was defined as ISS7 = 0. Itch (Pruritus) Severity Score Scale: 0 = None 1. = Mild (minimal awareness, easily tolerated) 2. = Moderate (definite awareness, bothersome but tolerable) 3. = Severe (difficult to tolerate)
The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.
The CU-Q2oL is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It consists of 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Participants are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1= not at all to 5= very much). An overall score is calculated and normalized to a scale of 1 to 100.
| Arm | Type | Description |
|---|---|---|
| Omalizumab 300mg | EXPERIMENTAL | patients received a dose of omalizumab 300 mg which consisted of two injections of omalizumab 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8) |
| Omalizumab 150mg | EXPERIMENTAL | patients received a dose of omalizumab 150 mg which consisted of one injection of omalizumab 150 mg vial and one injection of placebo 150 mg vial every 4 weeks (Day 1, Week 4 and Week 8) |
| Placebo | PLACEBO_COMPARATOR | patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8) |
| 1 Omalizumab | EXPERIMENTAL | omalizumab once a month via subcutaneous injection. |
| 2 Placebo | PLACEBO_COMPARATOR | placebo of omalizumab once a month via subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| Omalizumab | DRUG | injection of 150mg or 300 mg |
| Placebo | DRUG | Injection of placebo |
Main Inclusion Criteria: * Symptomatic CSU patients with CSU diagnosis for at least 6 months. * Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the Day -14 screening visit * Patients must have documented current use on the day ...