A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines

Launched by NOVARTIS PHARMACEUTICALS · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to compare two treatments—remibrutinib and dupilumab—for adults suffering from chronic spontaneous urticaria (CSU) that isn’t well controlled by standard antihistamines. CSU causes itchy hives that can be quite bothersome and, in this study, researchers want to see how effective these two medications are at relieving symptoms, especially within the first four weeks of treatment. Participants will take remibrutinib by mouth or receive dupilumab as an injection, and both treatments will be given alongside the usual antihistamines.

To be eligible for the trial, participants need to be at least 18 years old and have experienced CSU for at least six months without adequate relief from antihistamines. They must have ongoing symptoms, including itch and hives, despite using these medications. Participants will keep a daily diary to track their symptoms throughout the study. It’s important to note that individuals with certain health conditions or those who have previously used the study medications will not be able to join. The trial is not yet recruiting, so there will be more information available as it gets underway.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults ≥ 18 years of age at the time of signing the informed consent
• • CSU duration for ≥ 6 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 the time of randomization, defined as:
• * The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1):
• • UAS7 score (range, 0-42) ≥ 16, and
• • ISS7 score (range, 0-21) ≥ 6, and
• • HSS7 score (range, 0-21) ≥ 6
• • Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants 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 randomization (Day 1)
• Exclusion Criteria:
• • Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors
• • Previous use of dupilumab
• • Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, 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 hematological disorders (including coagulation disorders or significant bleeding risk)
• • History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), 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 75 mg/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-Coagulants \[NOAC\])
• • History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) \> 1.5 at screening