Efficacy of Remibrutinib versus Dupilumab at Early Timepoints in Chronic Spontaneous Urticaria: US Phase 3b Study Design (RECLAIM).
Gil Yosipovitch, Giselle Mosnaim, Christine-Elke Ortmann...
https://pubmed.ncbi.nlm.nih.gov/41854973Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06868212
A US Phase 3b, Multi-center, Randomized Study Comparing Remibrutinib to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Not Controlled by Second Generation H1-Antihistamines
Led by Novartis Pharmaceuticals · Updated on 2026-06-05
400
Participants Needed
128
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for adults in the US with moderate to severe chronic spontaneous urticaria (CSU) that is not well controlled by second generation H1-antihistamines (sgH1-AHs). The study is a Phase 3b, randomized, double-blind trial comparing remibrutinib, taken orally twice daily, to dupilumab, given as injections every two weeks, both added to standard antihistamine therapy. The trial aims to assess the early effectiveness of these treatments, focusing on improvements within the first four weeks. The trial includes a screening period up to 4 weeks to confirm eligibility, followed by a 12-week core treatment phase where about 400 participants will receive either remibrutinib with placebo injections or dupilumab with placebo tablets, alongside stable sgH1-AH background therapy. Participants can use additional antihistamines as rescue therapy if needed, up to a maximum daily dose. After the core phase, participants may join an optional 12-week open-label extension to receive remibrutinib, depending on its commercial availability. Safety follow-up continues for all participants, with phone calls and visits scheduled up to 24 weeks or longer if the extension continues. During the study, participants will complete daily diaries to track symptoms, and researchers will measure changes in urticaria activity scores at various time points, emphasizing Week 4. Safety and response will be monitored throughout, including phone follow-ups and site visits. Those who do not enter the extension will have safety calls at Weeks 16 and 24, while those in the extension will have continued monitoring until treatment ends or remibrutinib becomes commercially available. The total time involved may extend beyond 24 weeks depending on treatment continuation.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at the time of informed consent
- Chronic spontaneous urticaria lasting 6 months or longer before screening
- Diagnosis of CSU inadequately controlled by second generation H1-antihistamines at randomization
- Presence of itching and hives for 6 or more consecutive weeks before screening despite antihistamine use
- Urticaria Activity Score (UAS7) of 16 or higher
- Itch Severity Score (ISS7) of 6 or higher
- Hives Severity Score (HSS7) of 6 or higher
- Documentation of hives within 3 months before randomization
- Willing and able to complete a daily urticaria symptom diary during the study
- No more than one missing 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
- Hematological disorders including bleeding risks
- History or evidence of serious gastrointestinal disease or bleeding
- Requirement for certain anti-platelet medications other than low-dose aspirin or clopidogrel
- Use of dual anti-platelet therapy
- Requirement for anticoagulant medication such as warfarin or novel oral anticoagulants
- History or current liver disease including elevated liver enzymes or abnormal clotting tests at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 12 weeks
Participants receive either remibrutinib or dupilumab as an add-on treatment to daily second generation H1-antihistamines for chronic spontaneous urticaria.
Visits every 2 weeks during the 12-week treatment period
Optional Open-label Extension
Duration - 12 weeks
Participants may choose to continue receiving remibrutinib for an additional 12 weeks if remibrutinib is not commercially available at the end of the core treatment period.
Follow-up visits every 3 months for safety and treatment dispensation during extension
Safety Follow-up
Duration - At least 12 weeks
Participants are monitored for safety after treatment ends, with follow-up phone calls and visits depending on whether they enter the open-label extension.
Phone calls at Week 16 and Week 24; additional site visits and phone calls as needed after extension
Trial Site Locations
Total: 128 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
Clin Trial Inst of Northwest AR
Fayetteville, Arkansas, United States, 72703
Actively Recruiting
9
Acuro Research Inc
Little Rock, Arkansas, United States, 72205
Actively Recruiting
10
First OC Dermatology
Fountain Valley, California, United States, 92708
Actively Recruiting
11
Ctr for Dermatology Clinical Res
Fremont, California, United States, 95438
Actively Recruiting
12
Allergy and Asthma Specialists Group
Huntington Beach, California, United States, 92647
Actively Recruiting
13
Orso Health
Long Beach, California, United States, 90808
Actively Recruiting
14
Ark Clinical Research
Long Beach, California, United States, 90815
Actively Recruiting
15
California Allergy and Asthma Medical Group
Los Angeles, California, United States, 90025
Actively Recruiting
16
Dermatology Research Associates
Los Angeles, California, United States, 90045
Actively Recruiting
17
One Of A Kind Clinical Research
Napa, California, United States, 94558
Actively Recruiting
18
Empire Clinical Research
Pomona, California, United States, 91767
Actively Recruiting
19
Allergy and Asthma Consultants
Redwood City, California, United States, 94063
Actively Recruiting
20
Norcal Clinical Research
Rocklin, California, United States, 95765
Actively Recruiting
21
Peninsula Research Associates
Rolling Hills Estates, California, United States, 90274
Actively Recruiting
22
Integrative Skin Science and Res
Sacramento, California, United States, 95815
Actively Recruiting
23
UC Davis Neuromuscular Research Center
Sacramento, California, United States, 95817
Actively Recruiting
24
Therapeutics Clinical Research
San Diego, California, United States, 92123
Actively Recruiting
25
Dermatology Institute and Skin Care
Santa Monica, California, United States, 90404
Actively Recruiting
26
Integrated Research of Inland Inc
Upland, California, United States, 91786
Actively Recruiting
27
Allergy and Asthma Clin Res Inc
Walnut Creek, California, United States, 94598
Actively Recruiting
28
University of Colorado Hospital - Aurora
Aurora, Colorado, United States, 80045
Actively Recruiting
29
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
30
Colorado ENT and Allergy
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
31
Skylight Health Res Inc Color Spr
Colorado Springs, Colorado, United States, 80917
Actively Recruiting
32
UCONN Health Dermatology
Farmington, Connecticut, United States, 06030-2840
Actively Recruiting
33
Howard University Hospital Division of Geriatrics
Washington D.C., District of Columbia, United States, 20059
Actively Recruiting
34
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States, 33180
Actively Recruiting
35
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States, 33180
Actively Recruiting
36
Skin Care Research Inc
Boca Raton, Florida, United States, 33486
Actively Recruiting
37
Omnicure Clinical Research
Doral, Florida, United States, 33172
Actively Recruiting
38
FXM Clinical Research Ft Laud
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
39
Skin Care Research LLC
Hollywood, Florida, United States, 33021
Actively Recruiting
40
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Actively Recruiting
41
University of MiamiHealth System
Miami, Florida, United States, 33125
Actively Recruiting
42
FXM Clinical Res Miami LLC
Miami, Florida, United States, 33175
Actively Recruiting
43
Miami Dade Medical Research
Miami, Florida, United States, 33176
Actively Recruiting
44
FXM Clin Res Miramar LLC
Miramar, Florida, United States, 33027
Actively Recruiting
45
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33162
Actively Recruiting
46
AllerVie Health
Panama, Florida, United States, 32405
Actively Recruiting
47
Sarasota Clinical Research
Sarasota, Florida, United States, 34233
Actively Recruiting
48
Lenus Research and Med Group LLC
Sweetwater, Florida, United States, 33172
Actively Recruiting
49
Olympian Clinical Research
Tampa, Florida, United States, 33609
Actively Recruiting
50
Asthma Allergy Immunology Clin Res
Tampa, Florida, United States, 33613
Actively Recruiting
51
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
52
AllerVie Clin Res Columbus GA
Columbus, Georgia, United States, 31904
Actively Recruiting
53
Cleaver Medical Group
Cumming, Georgia, United States, 30040
Actively Recruiting
54
Southeast Dermatology Specialists
Douglasville, Georgia, United States, 30135
Actively Recruiting
55
Aeroallergy Research Laboratories
Savannah, Georgia, United States, 31406
Actively Recruiting
56
The Allergy Group-Meridian Clinic
Meridian, Idaho, United States, 83642
Actively Recruiting
57
NW Uni C and T Sciences Ins
Chicago, Illinois, United States, 60611
Actively Recruiting
58
Midwest Allergy Sinus Asthma SC
Normal, Illinois, United States, 61761
Actively Recruiting
59
Clinical Res Ctr of S Illinois
O'Fallon, Illinois, United States, 62269
Actively Recruiting
60
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States, 60305
Actively Recruiting
61
Endeavor Health Clinical Trials Center
Skokie, Illinois, United States, 60077
Actively Recruiting
62
Accellacare Duly Health and Care
Wheaton, Illinois, United States, 60189
Actively Recruiting
63
Deaconess Clin Allerg Res Inst
Evansville, Indiana, United States, 47715
Actively Recruiting
64
Southern IN Clinical Trials
New Albany, Indiana, United States, 47150
Actively Recruiting
65
McFarland Clinic PC
Ames, Iowa, United States, 50010
Actively Recruiting
66
Equity Medical LLC
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
67
Family Allergy And Asthma Rsch Inst
Louisville, Kentucky, United States, 40215
Actively Recruiting
68
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States, 42301
Actively Recruiting
69
Ochsner Health Center
Baton Rouge, Louisiana, United States, 70816
Actively Recruiting
70
Velocity Clinical Research
Lafayette, Louisiana, United States, 70508
Actively Recruiting
71
Johns Hopkins U School of Med
Baltimore, Maryland, United States, 21205
Actively Recruiting
72
Chesapeake Clinical Research Inc
Baltimore, Maryland, United States, 21236
Actively Recruiting
73
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
74
AllerVie Clin Res Glenn Dale
Glenn Dale, Maryland, United States, 20769
Actively Recruiting
75
Boston Specialists LLC
Boston, Massachusetts, United States, 02111
Actively Recruiting
76
ClinSite Inc
Ann Arbor, Michigan, United States, 48106-0525
Actively Recruiting
77
Derm Institute West Michigan PLLC
Caledonia, Michigan, United States, 49316
Actively Recruiting
78
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
79
Revival Research Institute
Troy, Michigan, United States, 48084
Actively Recruiting
80
Somerset Skin Centre
Troy, Michigan, United States, 48084
Actively Recruiting
81
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
Actively Recruiting
82
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
83
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
84
ENT and Allergy Center of Missouri
Columbia, Missouri, United States, 65201
Actively Recruiting
85
The Clinical Research Center
St Louis, Missouri, United States, 63141
Actively Recruiting
86
Washington University
St Louis, Missouri, United States, 63141
Actively Recruiting
87
Somnos Clinical Research
Lincoln, Nebraska, United States, 68510
Actively Recruiting
88
Allergy and Asthma Center of Las Vegas
Las Vegas, Nevada, United States, 89128
Actively Recruiting
89
Las Vegas Dermatology
Las Vegas, Nevada, United States, 89144
Actively Recruiting
90
Hudson Essex Allergy-Circuit Clinical
Belleville, New Jersey, United States, 07109
Actively Recruiting
91
Circuit Clinical Mercer Algy Pulm
Hamilton, New Jersey, United States, 08619
Actively Recruiting
92
Allergy Asthma Assoc Monmouth
Little Silver, New Jersey, United States, 07739
Actively Recruiting
93
Allergy Partners of New Jersey PC
Ocean Township, New Jersey, United States, 07712
Actively Recruiting
94
Circuit Clinical
Riverdale, New Jersey, United States, 07457
Actively Recruiting
95
Equity Medical
The Bronx, New York, United States, 10455
Actively Recruiting
96
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
97
Allergy Partners Of West NC
Asheville, North Carolina, United States, 28801
Actively Recruiting
98
UNC DermatologyandSkinCancer Ctr
Chapel Hill, North Carolina, United States, 27516
Actively Recruiting
99
Bernstein Clinical Research Center
Cincinnati, Ohio, United States, 45231
Actively Recruiting
100
CR Services Acquisition US
Columbus, Ohio, United States, 43213
Actively Recruiting
101
Optimed Research LLC
Columbus, Ohio, United States, 43235
Withdrawn
102
Wright State University
Fairborn, Ohio, United States, 45324
Actively Recruiting
103
Toledo Institute of Clinical Research
Toledo, Ohio, United States, 43617
Actively Recruiting
104
Unity Clinical Research
Oklahoma City, Oklahoma, United States, 73118
Actively Recruiting
105
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
106
Oregon Medical Research Center
Portland, Oregon, United States, 97223
Actively Recruiting
107
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
108
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States, 15241
Actively Recruiting
109
Medical Univ Of SC Medical Ctr
Charleston, South Carolina, United States, 29425
Actively Recruiting
110
Tribe Clinical Research LLC
Greenville, South Carolina, United States, 29601
Actively Recruiting
111
Allergic Disease and Asthma Center
Greenville, South Carolina, United States, 29607
Actively Recruiting
112
Charleston ENT and Allergy
North Charleston, South Carolina, United States, 29406
Actively Recruiting
113
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States, 29420
Actively Recruiting
114
International Clinical Research Tennessee LCC
Murfreesboro, Tennessee, United States, 37130
Actively Recruiting
115
Arlington Center for Dermatology
Arlington, Texas, United States, 76011
Actively Recruiting
116
Orion Clinical Research
Austin, Texas, United States, 78759
Actively Recruiting
117
Bellaire Dermatology Associates
Bellaire, Texas, United States, 77401
Actively Recruiting
118
Reveal Research Institute
Dallas, Texas, United States, 75230
Actively Recruiting
119
Pharma Research and Amp Consult
Dallas, Texas, United States, 75231
Actively Recruiting
120
Western Sky Medical Research
El Paso, Texas, United States, 79924
Actively Recruiting
121
Center for Clinical Studies
Houston, Texas, United States, 77030
Actively Recruiting
122
Sante Clinical Research
Kerrville, Texas, United States, 78028
Actively Recruiting
123
RFSA Dermatology
San Antonio, Texas, United States, 78213
Actively Recruiting
124
Andante Research
San Antonio, Texas, United States, 78229
Actively Recruiting
125
University Of Utah
Murray, Utah, United States, 84107
Actively Recruiting
126
Allergy Associates of Utah
Sandy City, Utah, United States, 84093
Actively Recruiting
127
Forefront Dermatology
Vienna, Virginia, United States, 22182
Actively Recruiting
128
Bellingham Asthma Allergy and Immunology
Bellingham, Washington, United States, 98225
Actively Recruiting
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Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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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