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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01803763 | Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients | PHASE2 | COMPLETED | 30 | — | — | Sep 1, 2012 | Mar 1, 2014 | Apr 15, 2014 | 1 | Switzerland |
| NCT00481676 | Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria | PHASE2 | COMPLETED | 49 | — | — | May 1, 2007 | Apr 1, 2009 | Oct 21, 2011 | 11 | Germany |
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Omalizumab (Xolair) | ACTIVE_COMPARATOR | Fixed dose of 300 mg omalizumab is subcutaneously administered in total 4 monthly doses |
| Placebo | PLACEBO_COMPARATOR | Fixed dose of Placebo is subcutaneously administered in total 4 monthly doses |
| Omalizumab 75-375 mg | EXPERIMENTAL | Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. |
| Placebo to omalizumab | PLACEBO_COMPARATOR | Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose. |
| Name | Type | Description |
|---|---|---|
| Omalizumab (Xolair) | DRUG | Fixed dose of 300 mg omalizumab is subcutaneously administered in total 4 monthly doses |
| Placebo | DRUG | Fixed dose of placebo is subcutaneously administered in total 4 monthly doses |
| Omalizumab 75-375 mg | DRUG | Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection. |
| Placebo to omalizumab | DRUG | Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection. |
| Loratadine | DRUG | All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines. |
| Clemastine | DRUG | All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines. |
Inclusion Criteria: * 1\. Diagnosis of chronic urticaria made by clinical symptoms and clinical investigations * 2\. Patients with chronic urticaria were defined as having symptoms for at least 6 weeks, with hives present at least twice weekly, refractory to H1 antihistaminics at time of randomizat...