Remibrutinib and omalizumab-based treatment approach for adults with chronic spontaneous urticaria not well controlled by antihistamines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, open-label phase 3 study explores a treatment algorithm that sequences remibrutinib and omalizumab in adults with CSU inadequately controlled by sgH1-antihistamines. Participants will follow the algorithm over 24 weeks to achieve faster and more stable control of symptoms. The study uses UAS7 and related patient-reported measures to assess efficacy and safety across multiple centers, including sites in Canada and Hong Kong. Enrollment targets adults with CSU lasting at least two months, with persistent symptoms despite sgH1-AH therapy. Key safety monitoring and daily symptom diaries will guide outcome evaluation.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Male and female adults (age ≥18 years) at the time of signing the informed consent.
2. CSU duration for ≥2 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation).
3. Diagnosis of CSU inadequately controlled by sgH1-AH at baseline defined as:

   * The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of sgH1-AH during this time period.
   * UAS7 score (range: 0-42) ≥16.
4. Documentation of hives within two months prior to baseline (either at screening and/or at baseline; or documented in the participant's medical history).
5. Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
6. Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to enrollment (Day 1).

Key Exclusion Criteria:

1. Previous use of remibrutinib, other Bruton's tyrosine kinase (BTK) inhibitors or prior exposure to biologics with any effect in CSU (e.g., ligelizumab, omalizumab, dupilumab, barzolvolimab).
2. Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or hematological disorders, 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 by the participant.
3. Significant bleeding risk or coagulation disorders.
4. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion).
5. Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
6. Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti- Coagulant - NOAC).
7. History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels of more than 1.5x upper limit of normal (ULN) or international normalized ratio (INR) of more than 1.5 at screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Novartis Investigative Site
  London, Ontario, Canada Recruiting
• Novartis Investigative Site
  Québec, Quebec, Canada Recruiting
• Novartis Investigative Site
  Hong Kong, Hong Kong, Hong Kong Recruiting
• Novartis Investigative Site
  Yokohama, Kanagawa, Japan Recruiting
• Novartis Investigative Site
  Yokohama, Kanagawa, Japan Recruiting
• Novartis Investigative Site
  Kamimashiki-gun, Kumamoto, Japan Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remibrutinib in real-world care for Chronic Spontaneous Urticaria in Germany

  This study looks at how well and how safely remibrutinib works for adults with chronic spontaneous urticaria in real clinical practice after doctors decide to switch or escalate treatment.

  Recruiting Novartis · Düren · NCT07642557

• Remibrutinib for adults with chronic spontaneous urticaria in routine care

  This prospective US study will see if remibrutinib helps adults with chronic spontaneous urticaria in real-world clinical practice using patient-reported outcome questionnaires.

  Recruiting Novartis · East Hanover, New Jersey · NCT07408219

• Remibrutinib use in everyday US care for chronic spontaneous urticaria

  This US sub-study will test remibrutinib's real-world safety and effectiveness for adults with chronic spontaneous urticaria who are escalating or switching from second-generation H1 antihistamines.

  Recruiting Novartis · Kirksville, Missouri · NCT07358780

• Remibrutinib use in everyday clinical care for chronic spontaneous urticaria

  This project sees if remibrutinib helps adults with chronic spontaneous urticaria who need higher‑dose second‑generation antihistamines or are switching to remibrutinib.

  Recruiting Novartis · Kirksville, Missouri · NCT07358364

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Oral Food Challenge After Starting Omalizumab in Food Allergy

  This trial tests whether omalizumab begins to help with food allergy within 2 to 4 weeks after starting treatment in people with a confirmed food allergy.

  Recruiting Phase 4 Johns Hopkins University · Baltimore, Maryland · NCT07845552

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.