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An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
Sponsor: Novartis Pharmaceuticals
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.
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
696
Start Date
2022-12-09
Completion Date
2027-08-02
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
LOU064 (blinded)
LOU064 (blinded) active treatment
Placebo
Placebo
LOU064 (open label)
LOU064 (open-label) active treatment
Locations (208)
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
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
John Hopkins University
Baltimore, Maryland, United States
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, United States
The Clinical Research Center
St Louis, Missouri, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
Allergy Asthma Assoc Monmouth
Little Silver, New Jersey, United States
Oakview Dermatology
Athens, Ohio, United States
CR Services Acquisition US
Columbus, Ohio, United States
Optimed Research LLC
Columbus, Ohio, United States
Toledo Institute of Clinical Research
Toledo, Ohio, United States
Allergy Asthma and Clinical Research
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States
Orion Clinical Research
Austin, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
RFSA Dermatology
San Antonio, Texas, United States
Allergy Associates of Utah
Sandy City, Utah, United States
Bellingham Asthma Allergy and Immunology
Bellingham, Washington, United States
Seattle Allergy and Asthma Rsch
Seattle, Washington, United States
Allergy Asthma and amp Sinus Ctr S C
Greenfield, Wisconsin, United States
Novartis Investigative Site
Berazategui, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Buenos Aires, Nueve De Julio, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Capital Federal, Argentina
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Santa Fe, Argentina
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East Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Santo André, São Paulo, Brazil
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Pleven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Kobenhavn N V, Denmark
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Alma Cruz-Santana Private Practice
Carolina, Puerto Rico
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