A Phase III Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment
Overview
- Phase
- Phase 3
- Intervention
- Omalizumab
- Conditions
- Chronic Spontaneous Urticaria
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 418
- Locations
- 1
- Primary Endpoint
- Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
Detailed Description
This was a randomized, multicenteric, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients of refractory CSU who remained symptomatic despite approved-dosed H1AH treatment. The study consisted of three distinct epochs over 24 weeks: Screening epoch (Day -28 to Day -1), Randomized treatment epoch (Day 1 to Week 12) and Post-treatment follow-up epoch (Week 12 to Week 20). Patients were randomized into three treatment groups (omalizumab 300 mg s.c. omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio, stratified by latent tuberculosis (TB) status at Baseline (Yes/No). On Day 1, eligible patients were randomly assigned to receive omalizumab (150 mg or 300 mg) or placebo by subcutaneous (s.c.) injection every 4 weeks (on Day 1, Week 4, and Week 8) during the 12-week double-blind randomized-treatment epoch. Patients visited the study center at 4-week intervals. Patients were instructed to stay on the same CSU H1AH treatment at stable dose that they were using during the pre-randomization period during the randomized treatment epoch. They were allowed to use diphenhydramine as rescue medication during all epochs. The last dose of the study drug during the randomized-treatment epoch was administered at Week 8 study visit, however, the last assessment was done at Week 12. After the completion of the 12-week randomized-treatment epoch, all patients entered an 8-week post-treatment follow-up epoch.
Investigators
Eligibility Criteria
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 of the initial screening visit
- •Main Exclusion Criteria
- •Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria)
- •Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer
Exclusion Criteria
- Not provided
Arms & Interventions
Omalizumab 300mg
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)
Intervention: Omalizumab
Omalizumab 150mg
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)
Intervention: Omalizumab
Placebo
patients received placebo which consisted of two injections of placebo 150 mg vials every 4 weeks (Day 1, Week 4 and Week 8)
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment
Time Frame: Baseline, Week 12
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)
Secondary Outcomes
- Percentage of Patients With UAS7≤6 at Week 12(Week 12)
- Percentage of Complete Responders (UAS7 = 0) at Week 12(Week 12)
- Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment(Week 12)
- Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment(Baseline, Week 12)
- Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment(Baseline, Week 12)
- Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12(Week 12)
- Time to ISS7 MID Response by Week 12(12 weeks)