Phase 3
N=218
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
Chronic Spontaneous Uriticaria
Bottom Line
View on ClinicalTrials.gov: NCT02329223 ↗Enrolled (actual)
218
Serious AEs
2.8%
Results posted
Sep 2016
Primary outcome: Primary: Change From Baseline in the Weekly Itch Severity Score at Week 12 — -10.22; -8.80; -6.51 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omalizumab (Biological); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Weekly Itch Severity Score at Week 12 |
-10.22; -8.80; -6.51 | <0.001 sig |
| SECONDARY Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12 |
-22.44; -18.79; -13.90 | — |
| SECONDARY Change From Baseline in the Weekly Number of Hives Score at Week 12 |
-12.17; -10.04; -7.41 | — |
| SECONDARY Percentage of Participants With a UAS7 Score ≤ 6 at Week 12 |
57.5; 42.9; 18.9 | — |
| SECONDARY Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12 |
-10.71; -9.30; -6.27 | — |
| SECONDARY Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12 |
87.7; 68.6; 55.4 | — |
| SECONDARY Percentage of Complete Responders (UAS7 = 0) at Week 12 |
35.6; 18.6; 4.1 | — |
| SECONDARY Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12 |
-8.4; -7.2; -5.3 | — |
| SECONDARY Percentage of Participants With Production of Anti-omalizumab Antibody |
0.0; 0.0; NA; NA | — |
Summary
This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
- Chronic spontaneous urticaria diagnosis for 6 months
Key Exclusion Criteria
- Weight less than 20 kg
- Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
- Evidence of parasitic infection
- Any other skin diseases than chronic spontaneous urticaria with chronic itching
- Previous treatment with omalizumab
- Contraindications to diphenhydramine
- History of anaphylactic shock
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- History of hypersensitivity to omalizumab or to drugs of similar chemical classes
- Pregnant or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT02329223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.