Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks

NCT07816328 | Recruiting Phase 3

• 1 other identifier: CLOU064A2307
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving Urticaria Activity Score over 7 days (UAS7) ≤6 (yes/no)

  UAS7 is a validated patient-reported measure of chronic spontaneous urticaria disease activity over 7 days. It is calculated as the sum of the weekly Hives Severity Score (HSS7) and the weekly Itch Severity Score (ISS7) and ranges from 0 to 42. Lower scores indicate lower disease activity / better disease control, and a score of ≤6 indicates well-controlled disease. HSS7 and ISS7 are each derived from daily diary entries over the 7 days preceding the visit.

  Week 24

Secondary Outcomes (7)

• Proportion of participants achieving UAS7 ≤6 (yes/no)

  Weeks 16 and 20

• Proportion of participants achieving UAS7 =0 (yes/no)

  Weeks 16, 20, and 24

• Proportion of participants achieving Angioedema Activity Score over 7 days (AAS7) =0.

  Weeks 16, 20, and 24

• Proportion of participants achieving of Dermatology Life Quality Index (DLQI) =0/1

  Weeks 16, 20, and 24

• Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  From Day 1 until at least 4 weeks after the last administration of remibrutinib and at least 16 weeks after the last administration of omalizumab

Study Arms (2)

Remibrutinib

EXPERIMENTAL

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

Drug: Remibrutinib

Remibrutinib or Omalizumab

EXPERIMENTAL

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.

Drug: Omalizumab

Interventions

Remibrutinib DRUG

Remibrutinib 25 mg twice a day.

Also known as: LOU064

Remibrutinib

Omalizumab DRUG

Omalizumab 300 mg every 4 weeks.

Remibrutinib or Omalizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults (age ≥18 years) at the time of signing the informed consent.
• CSU duration for ≥2 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation).
• 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.
• Documentation of hives within two months prior to baseline (either at screening and/or at baseline; or documented in the participant's medical history).
• 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 enrollment (Day 1).

You may not qualify if:

• 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).
• 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.
• Significant bleeding risk or coagulation disorders.
• 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).
• 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.
• Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti- Coagulant - NOAC).
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Hong Kong, Hong Kong, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Interventions

remibrutinib; Omalizumab

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+81337978748

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): June 2, 2028
• Study Completion (Estimated): June 2, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

HK (1)