Remibrutinib + Omalizumab for Chronic Urticaria
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this open-label study is to assess the efficacy and safety of a novel treatment algorithm for sequencing remibrutinib and omalizumab in the treatment of adult participants with chronic spontaneous urticaria (CSU) who are inadequately controlled by second-generation H1-antihistamines (sgH1-AH).
Are You a Good Fit for This Trial?
This trial is for adults (18+) with chronic spontaneous urticaria (CSU) who have had hives and itching for at least 6 weeks, haven't improved with second-generation H1-antihistamines, and can keep a daily symptom diary. Participants must have active symptoms recently.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Omalizumab
- Remibrutinib
Trial Overview
The study tests a new treatment plan using remibrutinib and omalizumab—either alone or in sequence—for people whose CSU isn't controlled by standard antihistamines. All participants know which treatment they receive.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive remibrutinib 25 mg twice a day. At Week 12, well-controlled participants (UCT7 ≥12) continue remibrutinib, while participants with inadequate control (UCT7 \<12) escalate to omalizumab 300 mg every 4 weeks.
Participants will receive remibrutinib 25 mg twice a day for 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
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