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

PHASE3RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

July 11, 2025

Primary Completion Date

May 11, 2027

Study Completion Date

August 3, 2027

Conditions
Chronic Spontaneous Urticaria (CSU)
Interventions
DRUG

Remibrutinib

Film-coated tablet, oral administration, 25 mg b.i.d.

DRUG

Remibrutinib matching placebo

Film-coated tablet, oral administration, b.i.d.

DRUG

Dupilumab

Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks

DRUG

Placebo solution for injection

Solution for injection in pre-filled syringe every 2 weeks

Trial Locations (59)

15241

RECRUITING

Allergy and Clinical Immunology Associates, Pittsburgh

20769

RECRUITING

AllerVie Clin Res Glenn Dale, Glenn Dale

21236

RECRUITING

Chesapeake Clinical Research Inc, Baltimore

29406

RECRUITING

Charleston ENT and Allergy, North Charleston

29420

RECRUITING

National Allergy and Asthma Research LLS, North Charleston

29601

RECRUITING

Tribe Clinical Research LLC, Greenville

29607

RECRUITING

Allergic Disease and Asthma Center, Greenville

30040

RECRUITING

Cleaver Medical Group, Cumming

31406

RECRUITING

Aeroallergy Research Laboratories, Savannah

31904

RECRUITING

AllerVie Clin Res Columbus GA, Columbus

32789

RECRUITING

Conquest Research, Winter Park

33021

RECRUITING

Skin Care Research LLC, Hollywood

33162

RECRUITING

Ziaderm Research LLC, North Miami Beach

33172

RECRUITING

Lenus Research and Med Group LLC, Sweetwater

33176

RECRUITING

Miami Dade Medical Research, Miami

33180

RECRUITING

Florida Ctr Allergy Asthma Research, Aventura

RECRUITING

Florida Ctr Allergy Asthma Research, Aventura

33486

RECRUITING

Skin Care Research Inc, Boca Raton

34233

RECRUITING

Sarasota Clinical Research, Sarasota

35209

RECRUITING

Allervie Clinical Research, Birmingham

40215

RECRUITING

Family Allergy And Asthma Rsch Inst, Louisville

42301

RECRUITING

Allergy and Asthma Specialist P S C, Owensboro

43213

RECRUITING

CR Services Acquisition US, Columbus

43235

RECRUITING

Optimed Research LLC, Columbus

47150

RECRUITING

Southern IN Clinical Trials, New Albany

48084

RECRUITING

Revival Research Institute, Troy

55402

RECRUITING

Clinical Research Institute, Minneapolis

60026

RECRUITING

Northshore University Health System, Glenview

60305

RECRUITING

Asthma and Allergy Center of Chicago S C, River Forest

62269

RECRUITING

Clinical Res Ctr of S Illinois, O'Fallon

63141

RECRUITING

The Clinical Research Center, St Louis

RECRUITING

Washington University, St Louis

72205

RECRUITING

Acuro Research Inc, Little Rock

74136

RECRUITING

Vital Prospects Clinical Research Institute, Tulsa

75231

RECRUITING

Pharma Research and Amp Consult, Dallas

76011

RECRUITING

Arlington Center for Dermatology, Arlington

77401

RECRUITING

Bellaire Dermatology Associates, Bellaire

78213

RECRUITING

RFSA Dermatology, San Antonio

78229

RECRUITING

Andante Research, San Antonio

78759

RECRUITING

Orion Clinical Research, Austin

79924

RECRUITING

Western Sky Medical Research, El Paso

80907

RECRUITING

Asthma and Allergy Associates P C, Colorado Springs

84093

RECRUITING

Allergy Associates of Utah, Sandy City

85032

RECRUITING

Premier Allergy Asthma And Immunology, Phoenix

85340

RECRUITING

Research Solutions of Arizona, Litchfield Park

89144

RECRUITING

Las Vegas Dermatology, Las Vegas

90025

RECRUITING

California Allergy and Asthma Medical Group, Los Angeles

90045

RECRUITING

Dermatology Research Associates, Los Angeles

90808

RECRUITING

Orso Health, Long Beach

90815

RECRUITING

Ark Clinical Research, Long Beach

91767

RECRUITING

Empire Clinical Research, Pomona

92647

RECRUITING

Allergy and Asthma Specialists Group, Huntington Beach

94598

RECRUITING

Allergy and Asthma Clin Res Inc, Walnut Creek

95438

RECRUITING

Ctr for Dermatology Clinical Res, Fremont

97223

RECRUITING

Oregon Medical Research Center, Portland

06030-2840

RECRUITING

UCONN Health Dermatology, Farmington

02111

RECRUITING

Boston Specialists LLC, Boston

08619

RECRUITING

Circuit Clinical Mercer Algy Pulm, Hamilton

37072-2301

RECRUITING

Goodlettsville Dermatology Research, Goodlettsville

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY