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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
Sponsor: Novartis Pharmaceuticals
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.
Official title: A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-07-11
Completion Date
2027-05-17
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Remibrutinib
Film-coated tablet, oral administration, 25 mg b.i.d.
Remibrutinib matching placebo
Film-coated tablet, oral administration, b.i.d.
Dupilumab
Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks
Placebo solution for injection
Solution for injection in pre-filled syringe every 2 weeks
Locations (114)
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
Peak Dermatology
Payson, Arizona, United States
Premier Allergy Asthma And Immunology
Phoenix, Arizona, United States
Avacare Center for Dermatology
Phoenix, Arizona, United States
Orso Health
Scottsdale, Arizona, United States
Acuro Research Inc
Little Rock, Arkansas, United States
First OC Dermatology
Fountain Valley, California, United States
Ctr for Dermatology Clinical Res
Fremont, California, United States
Allergy and Asthma Specialists Group
Huntington Beach, California, United States
Orso Health
Long Beach, California, United States
Ark Clinical Research
Long Beach, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
One Of A Kind Clinical Research
Napa, California, United States
Empire Clinical Research
Pomona, California, United States
Allergy and Asthma Consultants
Redwood City, California, United States
Norcal Clinical Research
Rocklin, California, United States
Integrative Skin Science and Res
Sacramento, California, United States
UC Davis Neuromuscular Research Center
Sacramento, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Integrated Research of Inland Inc
Upland, California, United States
Allergy and Asthma Clin Res Inc
Walnut Creek, California, United States
University of Colorado Hospital - Aurora
Aurora, Colorado, United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States
UCONN Health Dermatology
Farmington, Connecticut, United States
Howard University Hospital Division of Geriatrics
Washington D.C., District of Columbia, United States
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States
Skin Care Research Inc
Boca Raton, Florida, United States
Omnicure Clinical Research
Doral, Florida, United States
Skin Care Research LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University of MiamiHealth System
Miami, Florida, United States
FXM Clinical Res Miami LLC
Miami, Florida, United States
Miami Dade Medical Research
Miami, Florida, United States
FXM Clin Res Miramar LLC
Miramar, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
AllerVie Health
Panama, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Lenus Research and Med Group LLC
Sweetwater, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Asthma Allergy Immunology Clin Res
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
AllerVie Clin Res Columbus GA
Columbus, Georgia, United States
Cleaver Medical Group
Cumming, Georgia, United States
Southeast Dermatology Specialists
Douglasville, Georgia, United States
Aeroallergy Research Laboratories
Savannah, Georgia, United States
The Allergy Group-Meridian Clinic
Meridian, Idaho, United States
Midwest Allergy Sinus Asthma SC
Normal, Illinois, United States
Clinical Res Ctr of S Illinois
O'Fallon, Illinois, United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States
Deaconess Clin Allerg Res Inst
Evansville, Indiana, United States
Southern IN Clinical Trials
New Albany, Indiana, United States
Equity Medical LLC
Bowling Green, Kentucky, United States
Family Allergy And Asthma Rsch Inst
Louisville, Kentucky, United States
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States
Ochsner Health Center
Baton Rouge, Louisiana, United States
Velocity Clinical Research
Lafayette, Louisiana, United States
Johns Hopkins U School of Med
Baltimore, Maryland, United States
Chesapeake Clinical Research Inc
Baltimore, Maryland, United States
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, United States
AllerVie Clin Res Glenn Dale
Glenn Dale, Maryland, United States
Boston Specialists LLC
Boston, Massachusetts, United States
ClinSite Inc
Ann Arbor, Michigan, United States
Derm Institute West Michigan PLLC
Caledonia, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Revival Research Institute
Troy, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
The Clinical Research Center
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Las Vegas Dermatology
Las Vegas, Nevada, United States
Hudson Essex Allergy-Circuit Clinical
Belleville, New Jersey, United States
Circuit Clinical Mercer Algy Pulm
Hamilton, New Jersey, United States
Allergy Asthma Assoc Monmouth
Little Silver, New Jersey, United States
Circuit Clinical
Riverdale, New Jersey, United States
Equity Medical
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC DermatologyandSkinCancer Ctr
Chapel Hill, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
CR Services Acquisition US
Columbus, Ohio, United States
Optimed Research LLC
Columbus, Ohio, United States
Wright State University
Fairborn, Ohio, United States
Toledo Institute of Clinical Research
Toledo, Ohio, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Medical Univ Of SC Medical Ctr
Charleston, South Carolina, United States
Tribe Clinical Research LLC
Greenville, South Carolina, United States
Allergic Disease and Asthma Center
Greenville, South Carolina, United States
Charleston ENT and Allergy
North Charleston, South Carolina, United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States
International Clinical Research Tennessee, LCC
Murfreesboro, Tennessee, United States
Arlington Center for Dermatology
Arlington, Texas, United States
Orion Clinical Research
Austin, Texas, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Reveal Research Institute
Dallas, Texas, United States
Pharma Research and Amp Consult
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
RFSA Dermatology
San Antonio, Texas, United States
Andante Research
San Antonio, Texas, United States
University Of Utah
Murray, Utah, United States
Allergy Associates of Utah
Sandy City, Utah, United States
Forefront Dermatology
Vienna, Virginia, United States
Bellingham Asthma Allergy and Immunology
Bellingham, Washington, United States