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Monoclonal Antibodies
Remibrutinib for Hives
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CSU duration for ≥ 6 months prior to screening.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 68 weeks
Awards & highlights
Pivotal Trial
Summary
This trial will test the efficacy, safety and tolerability of two treatments for chronic spontaneous urticaria (CSU) not controlled by antihistamines.
Who is the study for?
Adults over 18 with chronic spontaneous urticaria (CSU) not well-controlled by antihistamines can join. They must have had hives and itching for at least 6 weeks despite treatment, and be able to keep a daily diary of their symptoms without missing more than one entry in the week before starting.
What is being tested?
The trial is testing Remibrutinib's effectiveness compared to a placebo and Omalizumab as an active control. Participants will take Remibrutinib or its placebo twice daily for 24 weeks, or Omalizumab every four weeks for 52 weeks.
What are the potential side effects?
Possible side effects include reactions at the injection site, headaches, nausea, dizziness, joint pain, and potential allergic responses. The exact side effects of Remibrutinib are being studied but may be similar to those observed with other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had chronic spontaneous urticaria for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 68 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 68 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7)
Secondary study objectives
Achievement of UAS7=0 (yes/no)
Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score
Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: RemibrutinibExperimental Treatment1 Intervention
Participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks.
Group II: OmalizumabActive Control1 Intervention
participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks.
Group III: Placebo to remibrutinibPlacebo Group1 Intervention
Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w.
Group IV: Placebo to omalizumabPlacebo Group1 Intervention
Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,219 Total Patients Enrolled
27 Trials studying Chronic Urticaria
8,348 Patients Enrolled for Chronic Urticaria