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

NCT05513001 · tracked via the Priya Life Science UK tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 3

Started

2022-12-09

Last updated

2026-03-11

Condition(s) studied

Chronic Spontaneous Urticaria

Investigational drug(s) / intervention(s)

LOU064 (blinded)PlaceboLOU064 (open label)

LOU064 (blinded): LOU064 (blinded) active treatment

Placebo: Placebo

LOU064 (open label): LOU064 (open-label) active treatment

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Time to first composite event (i.e., relapse (UAS7≥16) — 24 weeks
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. (Epoch 1) 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 (Epoch 1) Urticaria Activity Score (UAS7) describes the number of hives with 0 being No Hives and 3 is most severe. The final score is calculated by adding together daily scores which can range from 0-6 for 7 days. The resulting maximum score is then 42.

Trial sites (208)

Facility	City	Region
Allervie Clinical Research	Birmingham	Alabama
Cahaba Derm and skin hlth ctr 27	Birmingham	Alabama
Research Solutions of Arizona	Litchfield Park	Arizona
Acuro Research Inc	Little Rock	Arkansas
Arkansas Research Trials	North Little Rock	Arkansas
Kern Research	Bakersfield	California
Antelope Valley Clinical Trials	Lancaster	California
Allergy and Asthma Consultants	Redwood City	California
Asthma and Allergy Associates P C	Colorado Springs	Colorado
Colorado Allergy and Asthma Ctr PC	Denver	Colorado
UCONN Health Dermatology	Farmington	Connecticut
Florida Ctr Allergy Asthma Research	Aventura	Florida
Finlay Medical Research	Greenacres City	Florida
Miami Dade Medical Research	Miami	Florida
Sarasota Clinical Research	Sarasota	Florida
Allergy and Asthma Diagnostic Treatment Center	Tallahassee	Florida
Aeroallergy Research Laboratories	Savannah	Georgia
Treasure Valley Medical Research	Boise	Idaho
Endeavor Health	Glenview	Illinois
Asthma and Allergy Center of Chicago S C	River Forest	Illinois
Deaconess Clin Allerg Res Inst	Evansville	Indiana
The Indiana Clinical Trials Center	Plainfield	Indiana
Allergy and Asthma Specialist P S C	Owensboro	Kentucky
John Hopkins University	Baltimore	Maryland
Institute for Asthma and Allergy PC	Chevy Chase	Maryland
The Clinical Research Center	St Louis	Missouri
Somnos Clinical Research	Lincoln	Nebraska
Allergy Asthma Assoc Monmouth	Little Silver	New Jersey
Oakview Dermatology	Athens	Ohio
CR Services Acquisition US	Columbus	Ohio
Optimed Research LLC	Columbus	Ohio
Toledo Institute of Clinical Research	Toledo	Ohio
Allergy Asthma and Clinical Research	Oklahoma City	Oklahoma
Vital Prospects Clinical Research Institute	Tulsa	Oklahoma
Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania
National Allergy and Asthma Research LLS	North Charleston	South Carolina
Orion Clinical Research	Austin	Texas
Western Sky Medical Research	El Paso	Texas
RFSA Dermatology	San Antonio	Texas
Allergy Associates of Utah	Sandy City	Utah

+ 168 more sites — see the full list on the official registry below.

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Other trials for the same condition

24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up Active, not recruiting

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Enrolling by invitation

Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. Active, not recruiting

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05513001 on ClinicalTrials.gov ↗ ← All trials in the UK