NCT06868212 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
| NCT ID | NCT06868212 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Chronic Spontaneous Urticaria (CSU) |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2027-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-07-11 with a primary completion date of 2027-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06868212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Spontaneous Urticaria (CSU). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06868212 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT06868212 currently recruiting?
Yes, NCT06868212 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06868212 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Litchfield Park, United States, Payson, United States and 11 additional locations.
Who is sponsoring the NCT06868212 clinical trial?
NCT06868212 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 400 participants.