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Evaluating Remibrutinib for Chronic Spontaneous Urticaria

A Global, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib 25 mg b.i.d. in Comparison to Placebo With Omalizumab 300 mg Every 4 Weeks as Active Control Over 52 Weeks in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines and an Open-label 52-week Optional Extension to Assess Long-term Efficacy, Safety and Tolerability of Remibrutinib 25 mg b.i.d.

Phase 3 Interventional Novartis · NCT06042478

This study is testing if a new medication called remibrutinib can help adults with chronic hives who haven't found relief from other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment468 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsligelizumab, omalizumab, remibrutinib
Locations130 sites (Caba, Buenos Aires and 129 other locations)
Trial IDNCT06042478 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the efficacy, safety, and tolerability of remibrutinib compared to a placebo and omalizumab in adults with chronic spontaneous urticaria (CSU) who have not responded adequately to H1-antihistamines. The study consists of a core phase lasting 52 weeks, followed by an optional open-label extension phase of up to 52 weeks. Participants will be randomized into different treatment arms, receiving either remibrutinib or omalizumab, with a focus on measuring symptom relief and overall treatment effectiveness. The trial aims to provide insights into the long-term benefits of remibrutinib for CSU patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines.

Not a fit: Patients who have previously been treated with ligelizumab, omalizumab, or other biologics may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptom management for patients suffering from chronic spontaneous urticaria.

How similar studies have performed: Other studies have shown promise with similar biologic approaches for CSU, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male and female adult participants ≥18 years of age at the time of signing the informed consent.
* CSU duration for ≥ 6 months prior to screening.
* Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of randomization, defined as:
* The presence of itch and hives for ≥6 consecutive weeks prior to screening, despite the use of second-generation H1-AH during this time period.
* UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0- 21) ≥ 6 during the 7 days prior to randomization (Day 1).
* Documentation of hives within three months before randomization.
* Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
* Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).

Exclusion Criteria:

* Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.
* Significant bleeding risk or coagulation disorders.
* History of gastrointestinal bleeding.
* Requirement for anti-platelet or anti-coagulant medication.
* History or current hepatic disease.
* Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
* Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines.
* Documented history of anaphylaxis.
* Pregnant or nursing (lactating) women.

Where this trial is running

Caba, Buenos Aires and 129 other locations

+80 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Spontaneous UrticariaCSUurticariaLOU064omalizumabremibrutinib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.