An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Chronic Spontaneous Urticaria

In brief

The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.

Key facts

Study ID

NCT05513001

Run by

Novartis Pharmaceuticals

People needed

696

Starts

2022-12-09

Expected to finish

2027-08-02

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Significant bleeding risk or coagulation disorders.
• History of gastrointestinal bleeding.
• Requirement for anti-platelet medication.
• Requirement for anticoagulant medication.
• History or current hepatic disease.
• Evidence of clinically significant cardiovascular, 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.

Where it is running

• Allervie Clinical Research — Birmingham, Alabama, United States
• Cahaba Derm and skin hlth ctr 27 — Birmingham, Alabama, United States
• Research Solutions of Arizona — Litchfield Park, Arizona, United States
• Acuro Research Inc — Little Rock, Arkansas, United States
• Arkansas Research Trials — North Little Rock, Arkansas, United States
• Kern Research — Bakersfield, California, United States
• Antelope Valley Clinical Trials — Lancaster, California, United States
• Allergy and Asthma Consultants — Redwood City, California, United States
• Novartis Investigative Site — Madrid, Spain
• Asthma and Allergy Associates P C — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Ctr PC — Denver, Colorado, United States
• UCONN Health Dermatology — Farmington, Connecticut, United States
• Florida Ctr Allergy Asthma Research — Aventura, Florida, United States
• Finlay Medical Research — Greenacres City, Florida, United States
• Miami Dade Medical Research — Miami, Florida, United States
• Sarasota Clinical Research — Sarasota, Florida, United States
• Allergy and Asthma Diagnostic Treatment Center — Tallahassee, Florida, United States
• Aeroallergy Research Laboratories — Savannah, Georgia, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Endeavor Health — Glenview, Illinois, United States
• Asthma and Allergy Center of Chicago S C — River Forest, Illinois, United States
• Deaconess Clin Allerg Res Inst — Evansville, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Allergy and Asthma Specialist P S C — Owensboro, Kentucky, United States
• Novartis Investigative Site — Las Palmas GC, Spain

Full record on ClinicalTrials.gov

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