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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 68 weeks for reporting.

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 more

Awards & 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.

0 / 1Eligibility criteria met