Recruiting
Phase 3

Remibrutinib & Omalizumab

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07816328

Conditions

Chronic Spontaneous Urticaria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remibrutinib

Omalizumab

Study Details

Brief summary:

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).

Conditions

Chronic Spontaneous Urticaria

Study ID

NCT07816328

Start date

Sep 21, 2026

Status verified date

Nov, 2026

Completion date

May 24, 2028

Anticipated

Primary completion date

May 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

382 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Remibrutinib

Participants will receive remibrutinib 25 mg twice a day for 12 weeks.

experimental: Remibrutinib or Omalizumab

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.

Interventions

Remibrutinib

Remibrutinib 25 mg twice a day.

Omalizumab

Omalizumab 300 mg every 4 weeks.

Primary outcome measure

  • Proportion of participants achieving Urticaria Activity Score over 7 days (UAS7) ≤6 (yes/no) [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+81337978748

Locations

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6H 5L5

Novartis Investigative Site

Recruiting

Québec, Quebec, Canada, G1W 4R4

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Keywords

  • LOU064
  • CSU
  • Treatment algorithm
  • UAS7
  • UCT7
  • sgH1-AH
  • omalizumab
  • remibrutinib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.