An extension study of long-term efficacy, safety and tolerability of remibrutinib in chronic spontaneous urticaria patients who completed preceding studies with remibrutinib

Phase 1

• Conditions: Chronic Spontaneous Urticaria; MedDRA version: 20.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2022-001034-11-DK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1021

Inclusion Criteria

- Written informed consent must be obtained before any assessment is performed.
- Male and female, adult participants =18 years of age.
- Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
- Willing and able to adhere to the study protocol and visit schedule.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 919
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 102

Exclusion Criteria

- Other diseases with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria.
- Any other skin disease associated with chronic itching that might influence in the investigator’s opinion the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis.
- Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA (New York heart association) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to enrollment), neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease 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.
- Significant bleeding risk or coagulation disorders.
- History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant.
- 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 (NOACs)).
- 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 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at the last 2 available visits of the preceding core study.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Epoch 1: Randomized withdrawal period<br>To assess the efficacy of remibrutinib in CSU participants with a UAS7<16 at Week 52 in the prior core study with respect to time to first of the three events: relapse or study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication up to Week 24 compared to placebo;Secondary Objective: To assess the long-term safety and tolerability of remibrutinib;Primary end point(s): Time to first composite event (i.e., relapse (UAS7=16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the randomized withdrawal period;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Occurrence of treatment-emergent (serious and non-serious) adverse events during the extension study;Timepoint(s) of evaluation of this end point: End of Study