Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-03-11
400
Participants Needed
114
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 6 18 years of age at the time of signing the informed consent
- Chronic spontaneous urticaria (CSU) lasting at least 6 months before screening
- CSU inadequately controlled by second generation H1-antihistamines at randomization
- Presence of itch and hives for 6 consecutive weeks before screening despite antihistamine use
- Weekly Urticaria Activity Score (UAS7) of 16 or higher
- ISS7 score of 6 or higher
- HSS7 score of 6 or higher
- Documentation of hives within 3 months before randomization
- Willing and able to complete a daily urticaria diary during the study
- No more than one missed diary entry in the 7 days before randomization
You will not qualify if you...
- Previous use of remibrutinib or other Bruton's tyrosine kinase (BTK) inhibitors
- Previous use of dupilumab
- Significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic disorders, or immunodeficiency that may affect safety or study results
- Blood disorders or significant bleeding risk
- History or evidence of clinically relevant gastrointestinal disease including bleeding
- Need for anti-platelet medication other than low-dose aspirin (up to 100 mg/day) or clopidogrel (up to 75 mg/day)
- Use of dual anti-platelet therapy is prohibited
- Need for anticoagulant medication such as warfarin or novel oral anticoagulants
- History or current liver disease or abnormal liver function tests (AST/ALT more than 1.5 times upper limit or INR > 1.5) at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 114 locations
1
Allervie Clinical Research
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States, 35244
Actively Recruiting
3
Research Solutions of Arizona
Litchfield Park, Arizona, United States, 85340
Actively Recruiting
4
Peak Dermatology
Payson, Arizona, United States, 85541
Actively Recruiting
5
Premier Allergy Asthma And Immunology
Phoenix, Arizona, United States, 85032
Actively Recruiting
6
Avacare Center for Dermatology
Phoenix, Arizona, United States, 85044
Actively Recruiting
7
Orso Health
Scottsdale, Arizona, United States, 85254
Actively Recruiting
8
Acuro Research Inc
Little Rock, Arkansas, United States, 72205
Actively Recruiting
9
First OC Dermatology
Fountain Valley, California, United States, 92708
Actively Recruiting
10
Ctr for Dermatology Clinical Res
Fremont, California, United States, 95438
Actively Recruiting
11
Allergy and Asthma Specialists Group
Huntington Beach, California, United States, 92647
Actively Recruiting
12
Orso Health
Long Beach, California, United States, 90808
Actively Recruiting
13
Ark Clinical Research
Long Beach, California, United States, 90815
Actively Recruiting
14
California Allergy and Asthma Medical Group
Los Angeles, California, United States, 90025
Actively Recruiting
15
Dermatology Research Associates
Los Angeles, California, United States, 90045
Actively Recruiting
16
One Of A Kind Clinical Research
Napa, California, United States, 94558
Actively Recruiting
17
Empire Clinical Research
Pomona, California, United States, 91767
Actively Recruiting
18
Allergy and Asthma Consultants
Redwood City, California, United States, 94063
Actively Recruiting
19
Norcal Clinical Research
Rocklin, California, United States, 95765
Actively Recruiting
20
Integrative Skin Science and Res
Sacramento, California, United States, 95815
Actively Recruiting
21
UC Davis Neuromuscular Research Center
Sacramento, California, United States, 95817
Actively Recruiting
22
Therapeutics Clinical Research
San Diego, California, United States, 92123
Actively Recruiting
23
Integrated Research of Inland Inc
Upland, California, United States, 91786
Actively Recruiting
24
Allergy and Asthma Clin Res Inc
Walnut Creek, California, United States, 94598
Actively Recruiting
25
University of Colorado Hospital - Aurora
Aurora, Colorado, United States, 80045
Actively Recruiting
26
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
27
UCONN Health Dermatology
Farmington, Connecticut, United States, 06030-2840
Actively Recruiting
28
Howard University Hospital Division of Geriatrics
Washington D.C., District of Columbia, United States, 20059
Actively Recruiting
29
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States, 33180
Actively Recruiting
30
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States, 33180
Actively Recruiting
31
Skin Care Research Inc
Boca Raton, Florida, United States, 33486
Actively Recruiting
32
Omnicure Clinical Research
Doral, Florida, United States, 33172
Actively Recruiting
33
Skin Care Research LLC
Hollywood, Florida, United States, 33021
Actively Recruiting
34
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
35
University of MiamiHealth System
Miami, Florida, United States, 33125
Actively Recruiting
36
FXM Clinical Res Miami LLC
Miami, Florida, United States, 33175
Actively Recruiting
37
Miami Dade Medical Research
Miami, Florida, United States, 33176
Actively Recruiting
38
FXM Clin Res Miramar LLC
Miramar, Florida, United States, 33027
Actively Recruiting
39
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33162
Actively Recruiting
40
AllerVie Health
Panama, Florida, United States, 32405
Actively Recruiting
41
Sarasota Clinical Research
Sarasota, Florida, United States, 34233
Actively Recruiting
42
Lenus Research and Med Group LLC
Sweetwater, Florida, United States, 33172
Actively Recruiting
43
Olympian Clinical Research
Tampa, Florida, United States, 33609
Actively Recruiting
44
Asthma Allergy Immunology Clin Res
Tampa, Florida, United States, 33613
Actively Recruiting
45
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
46
AllerVie Clin Res Columbus GA
Columbus, Georgia, United States, 31904
Actively Recruiting
47
Cleaver Medical Group
Cumming, Georgia, United States, 30040
Actively Recruiting
48
Southeast Dermatology Specialists
Douglasville, Georgia, United States, 30135
Actively Recruiting
49
Aeroallergy Research Laboratories
Savannah, Georgia, United States, 31406
Actively Recruiting
50
The Allergy Group-Meridian Clinic
Meridian, Idaho, United States, 83642
Actively Recruiting
51
Midwest Allergy Sinus Asthma SC
Normal, Illinois, United States, 61761
Actively Recruiting
52
Clinical Res Ctr of S Illinois
O'Fallon, Illinois, United States, 62269
Actively Recruiting
53
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States, 60305
Actively Recruiting
54
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States, 60077
Actively Recruiting
55
Deaconess Clin Allerg Res Inst
Evansville, Indiana, United States, 47715
Actively Recruiting
56
Southern IN Clinical Trials
New Albany, Indiana, United States, 47150
Actively Recruiting
57
Equity Medical LLC
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
58
Family Allergy And Asthma Rsch Inst
Louisville, Kentucky, United States, 40215
Actively Recruiting
59
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States, 42301
Actively Recruiting
60
Ochsner Health Center
Baton Rouge, Louisiana, United States, 70816
Actively Recruiting
61
Velocity Clinical Research
Lafayette, Louisiana, United States, 70508
Actively Recruiting
62
Johns Hopkins U School of Med
Baltimore, Maryland, United States, 21205
Actively Recruiting
63
Chesapeake Clinical Research Inc
Baltimore, Maryland, United States, 21236
Actively Recruiting
64
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
65
AllerVie Clin Res Glenn Dale
Glenn Dale, Maryland, United States, 20769
Actively Recruiting
66
Boston Specialists LLC
Boston, Massachusetts, United States, 02111
Actively Recruiting
67
ClinSite Inc
Ann Arbor, Michigan, United States, 48106-0525
Actively Recruiting
68
Derm Institute West Michigan PLLC
Caledonia, Michigan, United States, 49316
Actively Recruiting
69
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
70
Revival Research Institute
Troy, Michigan, United States, 48084
Actively Recruiting
71
Somerset Skin Centre
Troy, Michigan, United States, 48084
Actively Recruiting
72
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
Actively Recruiting
73
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
74
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
75
The Clinical Research Center
St Louis, Missouri, United States, 63141
Actively Recruiting
76
Washington University
St Louis, Missouri, United States, 63141
Actively Recruiting
77
Las Vegas Dermatology
Las Vegas, Nevada, United States, 89144
Actively Recruiting
78
Hudson Essex Allergy-Circuit Clinical
Belleville, New Jersey, United States, 07109
Actively Recruiting
79
Circuit Clinical Mercer Algy Pulm
Hamilton, New Jersey, United States, 08619
Actively Recruiting
80
Allergy Asthma Assoc Monmouth
Little Silver, New Jersey, United States, 07739
Actively Recruiting
81
Circuit Clinical
Riverdale, New Jersey, United States, 07457
Actively Recruiting
82
Equity Medical
The Bronx, New York, United States, 10455
Actively Recruiting
83
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
84
UNC DermatologyandSkinCancer Ctr
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
85
Bernstein Clinical Research Center
Cincinnati, Ohio, United States, 45231
Actively Recruiting
86
CR Services Acquisition US
Columbus, Ohio, United States, 43213
Actively Recruiting
87
Optimed Research LLC
Columbus, Ohio, United States, 43235
Withdrawn
88
Wright State University
Fairborn, Ohio, United States, 45324
Actively Recruiting
89
Toledo Institute of Clinical Research
Toledo, Ohio, United States, 43617
Actively Recruiting
90
Unity Clinical Research
Oklahoma City, Oklahoma, United States, 73118
Actively Recruiting
91
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
92
Oregon Medical Research Center
Portland, Oregon, United States, 97223
Actively Recruiting
93
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
94
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States, 15241
Actively Recruiting
95
Medical Univ Of SC Medical Ctr
Charleston, South Carolina, United States, 29425
Actively Recruiting
96
Tribe Clinical Research LLC
Greenville, South Carolina, United States, 29601
Actively Recruiting
97
Allergic Disease and Asthma Center
Greenville, South Carolina, United States, 29607
Actively Recruiting
98
Charleston ENT and Allergy
North Charleston, South Carolina, United States, 29406
Actively Recruiting
99
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States, 29420
Actively Recruiting
100
International Clinical Research Tennessee, LCC
Murfreesboro, Tennessee, United States, 37130
Actively Recruiting
101
Arlington Center for Dermatology
Arlington, Texas, United States, 76011
Actively Recruiting
102
Orion Clinical Research
Austin, Texas, United States, 78759
Actively Recruiting
103
Bellaire Dermatology Associates
Bellaire, Texas, United States, 77401
Actively Recruiting
104
Reveal Research Institute
Dallas, Texas, United States, 75230
Actively Recruiting
105
Pharma Research and Amp Consult
Dallas, Texas, United States, 75231
Actively Recruiting
106
Western Sky Medical Research
El Paso, Texas, United States, 79924
Actively Recruiting
107
Center for Clinical Studies
Houston, Texas, United States, 77030
Actively Recruiting
108
Sante Clinical Research
Kerrville, Texas, United States, 78028
Actively Recruiting
109
RFSA Dermatology
San Antonio, Texas, United States, 78213
Actively Recruiting
110
Andante Research
San Antonio, Texas, United States, 78229
Actively Recruiting
111
University Of Utah
Murray, Utah, United States, 84107
Actively Recruiting
112
Allergy Associates of Utah
Sandy City, Utah, United States, 84093
Actively Recruiting
113
Forefront Dermatology
Vienna, Virginia, United States, 22182
Actively Recruiting
114
Bellingham Asthma Allergy and Immunology
Bellingham, Washington, United States, 98225
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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