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 (RECLAIM)

June 4, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study consists of a screening period (up to 4 weeks), a core treatment period (12 weeks double-blind, double-dummy), an optional open-label extension [OLE] period, and safety follow-up period.

Screening period: participants will have a screening period of a minimum of 7 days up to a maximum of 28 days to establish eligibility for the study. Participants meeting all the inclusion criteria and none of the exclusion criteria will be eligible to participate in the study.

Core treatment period (double-blind, double-dummy): approximately, 400 participants diagnosed with CSU inadequately controlled by sgH1-AH will be randomized in this study. Participants will be stratified based on prior exposure to anti-IgE biologics.

Eligible participants will be randomized in a 1:1 ratio to receive remibrutinib and placebo solution for injection or dupilumab and remibrutinib matching placebo, both as an add-on treatment to once daily standard label dose of sgH1-AH background therapy, until the Week 12 visit.

Additionally, all participants will be on a stable, standard label dose of a sgH1-AH ("background therapy") throughout the entire core treatment period (starting a minimum of 7 days prior to randomization until the end of Week 12). To treat unbearable symptoms of CSU, participants will be allowed to add more of the same sgH1-AH on an as-needed basis ("rescue therapy"). The total maximum daily dose of sgH1-AH (background plus rescue) should not exceed 4 tablets/day (4-fold the standard label dose).

Optional open-label extension [OLE] period: At the end of the 12-week double-blind treatment period, and in case remibrutinib is not commercially available, participants from both arms will be given the choice to roll over into an optional OLE safety period and receive remibrutinib (25 mg b.i.d. p.o.) for 12 weeks (up to Week 24).

Safety follow-up period:

  • For participants who do not enter the OLE period: there will be a safety follow-up for 12 weeks with safety follow-up phone calls at Week 16 and Week 24 (Week 24 will be end of study).
  • For participants who enter the OLE period: there will be 2 options at the end of Week 24:
  • If remibrutinib is commercially available: participants will discontinue study treatment, perform their EOT visit and receive a safety follow-up phone call 4 weeks after the last dose of remibrutinib (this will be the EOS).
  • If remibrutinib is not commercially available, participants may continue on remibrutinib 25 mg b.i.d. until its commercial availability and return for site visits for safety follow up and treatment dispensation every 3 months. When remibrutinib becomes commercially available, the participant will be contacted for a site visit to complete the EOT visit and will receive a safety follow-up phone call 4 weeks after the last dose of remibrutinib (this will be the EOS).

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Allervie Clinical Research
        • Principal Investigator:
          • Weily Soong
        • Contact:
      • Birmingham, Alabama, United States, 35244
        • Recruiting
        • Cahaba Derm and skin hlth ctr 27
        • Principal Investigator:
          • Vlada Groysman
        • Contact:
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Recruiting
        • Research Solutions of Arizona
        • Principal Investigator:
          • Connie Hsu
        • Contact:
          • Phone Number: 623-512-4340
      • Payson, Arizona, United States, 85541
        • Recruiting
        • Peak Dermatology
        • Contact:
        • Principal Investigator:
          • Christopher Rex
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Premier Allergy Asthma And Immunology
        • Principal Investigator:
          • Kiranjit Khalsa
        • Contact:
      • Phoenix, Arizona, United States, 85044
        • Recruiting
        • Avacare Center for Dermatology
        • Principal Investigator:
          • Kenneth Steil
        • Contact:
      • Scottsdale, Arizona, United States, 85254
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Clin Trial Inst of Northwest AR
        • Contact:
        • Principal Investigator:
          • Mildred Clifton
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Acuro Research Inc
        • Principal Investigator:
          • Karl Sitz
        • Contact:
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • First OC Dermatology
        • Principal Investigator:
          • Vivian Laquer
        • Contact:
      • Fremont, California, United States, 95438
        • Recruiting
        • Ctr for Dermatology Clinical Res
        • Principal Investigator:
          • Sunil Dhawan
        • Contact:
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Allergy and Asthma Specialists Group
        • Principal Investigator:
          • Steven F Weinstein
        • Contact:
      • Long Beach, California, United States, 90815
      • Long Beach, California, United States, 90808
        • Recruiting
        • Orso Health
        • Principal Investigator:
          • Steven M Meltzer
        • Contact:
      • Los Angeles, California, United States, 90045
        • Recruiting
        • Dermatology Research Associates
        • Principal Investigator:
          • Howard Lee Sofen
        • Contact:
      • Los Angeles, California, United States, 90025
        • Recruiting
        • California Allergy and Asthma Medical Group
        • Principal Investigator:
          • Ricardo Tan
        • Contact:
      • Napa, California, United States, 94558
        • Recruiting
        • One Of A Kind Clinical Research
        • Contact:
        • Principal Investigator:
          • Sam Ahn
      • Pomona, California, United States, 91767
      • Redwood City, California, United States, 94063
      • Rocklin, California, United States, 95765
      • Rolling Hills Estates, California, United States, 90274
      • Sacramento, California, United States, 95815
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Neuromuscular Research Center
        • Principal Investigator:
          • Emanual Maverakis
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Therapeutics Clinical Research
        • Principal Investigator:
          • Neal Bhatia
        • Contact:
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Dermatology Institute and Skin Care
        • Principal Investigator:
          • Paul Yamauchi
        • Contact:
      • Upland, California, United States, 91786
        • Recruiting
        • Integrated Research of Inland Inc
        • Contact:
        • Principal Investigator:
          • Amit I Patel
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Allergy and Asthma Clin Res Inc
        • Principal Investigator:
          • Joshua S Jacobs
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital - Aurora
        • Contact:
        • Principal Investigator:
          • Jenny Stitt
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Asthma and Allergy Associates P C
        • Principal Investigator:
          • Daniel Soteres
        • Contact:
      • Colorado Springs, Colorado, United States, 80917
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • Colorado ENT and Allergy
        • Principal Investigator:
          • Eric Caplan
        • Contact:
    • Connecticut
      • Farmington, Connecticut, United States, 06030-2840
        • Recruiting
        • UCONN Health Dermatology
        • Principal Investigator:
          • Jun Lu
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20059
        • Recruiting
        • Howard University Hospital Division of Geriatrics
        • Contact:
        • Principal Investigator:
          • Carla Davis
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Florida Ctr Allergy Asthma Research
        • Principal Investigator:
          • Jaime Landman
        • Contact:
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Skin Care Research Inc
        • Principal Investigator:
          • Ann Reed
        • Contact:
      • Doral, Florida, United States, 33172
      • Fort Lauderdale, Florida, United States, 33308
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Skin Care Research LLC
        • Principal Investigator:
          • Eduardo Weiss
        • Contact:
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Jacksonville Center for Clinical Research
        • Principal Investigator:
          • Steve Dorman
        • Contact:
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Dade Medical Research
        • Principal Investigator:
          • Vicente Chavarria
        • Contact:
      • Miami, Florida, United States, 33125
        • Recruiting
        • University of MiamiHealth System
        • Principal Investigator:
          • Gil Yosipovitch
        • Contact:
      • Miami, Florida, United States, 33175
      • Miramar, Florida, United States, 33027
      • North Miami Beach, Florida, United States, 33162
        • Recruiting
        • Ziaderm Research LLC
        • Principal Investigator:
          • Tory Sullivan
        • Contact:
      • Panama, Florida, United States, 32405
        • Recruiting
        • AllerVie Health
        • Principal Investigator:
          • Maxcie Sikora
        • Contact:
      • Sarasota, Florida, United States, 34233
        • Recruiting
        • Sarasota Clinical Research
        • Principal Investigator:
          • Hugh Harmon Windom
        • Contact:
      • Sweetwater, Florida, United States, 33172
        • Recruiting
        • Lenus Research and Med Group LLC
        • Principal Investigator:
          • John Niven
        • Contact:
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Olympian Clinical Research
        • Principal Investigator:
          • Matthew Zook
        • Contact:
      • Tampa, Florida, United States, 33613
        • Recruiting
        • Asthma Allergy Immunology Clin Res
        • Principal Investigator:
          • Amber N Pepper
        • Contact:
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research
        • Principal Investigator:
          • Michael Wangia
        • Contact:
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • AllerVie Clin Res Columbus GA
        • Principal Investigator:
          • Robert R Chrzanowski
        • Contact:
      • Cumming, Georgia, United States, 30040
        • Recruiting
        • Cleaver Medical Group
        • Principal Investigator:
          • Weston Waxweiler
        • Contact:
      • Douglasville, Georgia, United States, 30135
        • Recruiting
        • Southeast Dermatology Specialists
        • Principal Investigator:
          • Firas Hougeir
        • Contact:
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Aeroallergy Research Laboratories
        • Principal Investigator:
          • Bruce Finkel
        • Contact:
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • The Allergy Group-Meridian Clinic
        • Principal Investigator:
          • Neetu Talreja
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Midwest Allergy Sinus Asthma SC
        • Principal Investigator:
          • Dareen D Siri
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Clinical Res Ctr of S Illinois
        • Principal Investigator:
          • Patrick Win
        • Contact:
      • River Forest, Illinois, United States, 60305
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Endeavor Health Clinical Trials Center
        • Principal Investigator:
          • Giselle Mosnaim
        • Contact:
      • Wheaton, Illinois, United States, 60189
        • Recruiting
        • Accellacare Duly Health and Care
        • Contact:
        • Principal Investigator:
          • James Herrmann
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Recruiting
        • Deaconess Clin Allerg Res Inst
        • Principal Investigator:
          • Anne Mclaughlin
        • Contact:
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Southern IN Clinical Trials
        • Contact:
        • Principal Investigator:
          • Megan Landis
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic PC
        • Contact:
        • Principal Investigator:
          • Jason Allen Cascio
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Recruiting
        • Equity Medical LLC
        • Principal Investigator:
          • David Johnson
        • Contact:
      • Louisville, Kentucky, United States, 40215
        • Recruiting
        • Family Allergy And Asthma Rsch Inst
        • Principal Investigator:
          • James Wesley Sublett
        • Contact:
      • Owensboro, Kentucky, United States, 42301
        • Recruiting
        • Allergy and Asthma Specialist P S C
        • Principal Investigator:
          • Lee Clore
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70816
        • Recruiting
        • Ochsner Health Center
        • Principal Investigator:
          • Kelser Bourgoyne
        • Contact:
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Velocity Clinical Research
        • Principal Investigator:
          • Jibran Atwi
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Recruiting
        • Chesapeake Clinical Research Inc
        • Contact:
        • Principal Investigator:
          • Jonathan Matz
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins U School of Med
        • Contact:
        • Principal Investigator:
          • Eric Tyrell Oliver
      • Chevy Chase, Maryland, United States, 20815
        • Recruiting
        • Institute for Asthma and Allergy PC
        • Principal Investigator:
          • Mark Scarupa
        • Contact:
      • Glenn Dale, Maryland, United States, 20769
        • Recruiting
        • AllerVie Clin Res Glenn Dale
        • Principal Investigator:
          • Arnold Kirshenbaum
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Boston Specialists LLC
        • Principal Investigator:
          • John Leung
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48106-0525
        • Recruiting
        • ClinSite Inc
        • Contact:
        • Principal Investigator:
          • Rajan Ravikumar
      • Caledonia, Michigan, United States, 49316
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Alan Baptist
        • Contact:
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Somerset Skin Centre
        • Principal Investigator:
          • George Murakawa
        • Contact:
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Revival Research Institute
        • Principal Investigator:
          • Ali Moiin
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Paul Bigliardi
      • Minneapolis, Minnesota, United States, 55402
        • Recruiting
        • Clinical Research Institute
        • Principal Investigator:
          • Hemalini Mehta
        • Contact:
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - Rochester
        • Contact:
        • Principal Investigator:
          • Gerald Volcheck
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • ENT and Allergy Center of Missouri
        • Principal Investigator:
          • Christine Franzese
        • Contact:
      • St Louis, Missouri, United States, 63141
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Washington University
        • Contact:
        • Principal Investigator:
          • Maya Jerath
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Recruiting
        • Somnos Clinical Research
        • Principal Investigator:
          • Robert J Szalewski
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Las Vegas Dermatology
        • Principal Investigator:
          • David Graham Cotter
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Allergy and Asthma Center of Las Vegas
        • Contact:
        • Principal Investigator:
          • Jason Bellak
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Recruiting
        • Hudson Essex Allergy-Circuit Clinical
        • Contact:
        • Principal Investigator:
          • Mark Edward Weinstein
      • Hamilton, New Jersey, United States, 08619
        • Recruiting
        • Circuit Clinical Mercer Algy Pulm
        • Contact:
        • Principal Investigator:
          • Peter Ricketti
      • Little Silver, New Jersey, United States, 07739
        • Recruiting
        • Allergy Asthma Assoc Monmouth
        • Principal Investigator:
          • Tina Zecca
        • Contact:
      • Ocean Township, New Jersey, United States, 07712
      • Riverdale, New Jersey, United States, 07457
        • Recruiting
        • Circuit Clinical
        • Principal Investigator:
          • Jeffrey Weiss
        • Contact:
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Golda Hudes
        • Contact:
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Equity Medical
        • Contact:
        • Principal Investigator:
          • Alissa McInerney
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Chapel Hill, North Carolina, United States, 27516
        • Recruiting
        • UNC DermatologyandSkinCancer Ctr
        • Contact:
        • Principal Investigator:
          • Donna Culton
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Recruiting
        • Bernstein Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Jonathan Abram Bernstein
      • Columbus, Ohio, United States, 43213
      • Columbus, Ohio, United States, 43235
        • Withdrawn
        • Optimed Research LLC
      • Fairborn, Ohio, United States, 45324
        • Recruiting
        • Wright State University
        • Principal Investigator:
          • Craig Rohan
        • Contact:
      • Toledo, Ohio, United States, 43617
        • Recruiting
        • Toledo Institute of Clinical Research
        • Principal Investigator:
          • Syed Rehman
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Recruiting
        • Unity Clinical Research
        • Principal Investigator:
          • Jarad Levin
        • Contact:
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Vital Prospects Clinical Research Institute
        • Principal Investigator:
          • Iftikhar Hussain
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Sciences University
        • Principal Investigator:
          • Shyam Joshi
        • Contact:
      • Portland, Oregon, United States, 97223
        • Recruiting
        • Oregon Medical Research Center
        • Principal Investigator:
          • Jason Hawkes
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Recruiting
        • Allergy and Clinical Immunology Associates
        • Principal Investigator:
          • Michael Palumbo
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical Univ Of SC Medical Ctr
        • Principal Investigator:
          • Kelli Williams
        • Contact:
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Allergic Disease and Asthma Center
        • Principal Investigator:
          • Neil L Kao
        • Contact:
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Tribe Clinical Research LLC
        • Contact:
        • Principal Investigator:
          • James Kuhlen
      • North Charleston, South Carolina, United States, 29420
        • Recruiting
        • National Allergy and Asthma Research LLS
        • Contact:
        • Principal Investigator:
          • John T Ramey
      • North Charleston, South Carolina, United States, 29406
        • Recruiting
        • Charleston ENT and Allergy
        • Principal Investigator:
          • Thomas Murphy
        • Contact:
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • Recruiting
        • International Clinical Research Tennessee LCC
        • Principal Investigator:
          • Christina Feser
        • Contact:
    • Texas
      • Arlington, Texas, United States, 76011
        • Recruiting
        • Arlington Center for Dermatology
        • Principal Investigator:
          • Angela Moore
        • Contact:
      • Austin, Texas, United States, 78759
        • Recruiting
        • Orion Clinical Research
        • Principal Investigator:
          • William Howland III
        • Contact:
      • Bellaire, Texas, United States, 77401
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Pharma Research and Amp Consult
        • Principal Investigator:
          • Gary Gross
        • Contact:
      • Dallas, Texas, United States, 75230
      • El Paso, Texas, United States, 79924
        • Recruiting
        • Western Sky Medical Research
        • Principal Investigator:
          • Todd Funkhouser
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Center for Clinical Studies
        • Contact:
        • Principal Investigator:
          • Stephen K Tyring
      • Kerrville, Texas, United States, 78028
        • Recruiting
        • Sante Clinical Research
        • Principal Investigator:
          • Dale E Mohar
        • Contact:
      • San Antonio, Texas, United States, 78213
      • San Antonio, Texas, United States, 78229
    • Utah
      • Murray, Utah, United States, 84107
      • Sandy City, Utah, United States, 84093
        • Recruiting
        • Allergy Associates of Utah
        • Principal Investigator:
          • Andrew Smith
        • Contact:
    • Virginia
      • Vienna, Virginia, United States, 22182
    • Washington
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • Bellingham Asthma Allergy and Immunology
        • Principal Investigator:
          • David Elkayam
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥ 18 years of age at the time of signing the informed consent
  • CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the Investigator based on all available supporting documentation)
  • Diagnosis of CSU inadequately controlled by sgH1-AH at the time of randomization, defined as:
  • The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of sgH1-AH during the 7 days prior to randomization (Day 1):
  • UAS7 score (range, 0-42) ≥ 16, and
  • ISS7 score (range, 0-21) ≥ 6, and
  • HSS7 score (range, 0-21) ≥ 6
  • Documentation of hives within 3 months before randomization (either at screening and/or at randomization); or documented in the participants medical history
  • Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol
  • Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1)

Exclusion Criteria:

  • Previous use of remibrutinib or other bruton's tyrosine kinase (BTK) inhibitors
  • Previous use of dupilumab
  • Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1), neurological, psychiatric, pulmonary, renal, hepatic (past history or current), endocrine or metabolic disorder, or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
  • Evidence of hematological disorders (including coagulation disorders or significant bleeding risk)
  • History or evidence of gastrointestinal disease (including gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion)
  • Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
  • Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants [NOAC])
  • History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or hepatic parameters at screening: Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels more than 1.5x ULN or International Normalized Ratio (INR) > 1.5 at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group 1: Remibrutinib + Placebo
Remibrutinib tablet (25 mg b.i.d. p.o.) + placebo solution for injection in pre-filled syringe (2 s.c. injections at baseline and then 1 s.c. injection every other week [Weeks 2-10])
Drug: Remibrutinib
Film-coated tablet, oral administration, 25 mg b.i.d.
Drug: Placebo solution for injection
Solution for injection in pre-filled syringe every 2 weeks
Active Comparator: Treatment group 2: Dupilumab + remibrutinib matching placebo
Dupilumab pre-filled syringe (600 mg loading dose [2 x 300 mg dupilumab s.c. injection] at baseline visit followed by dupilumab 300 mg s.c. injection every other week [Weeks 2-10]) + remibrutinib matching placebo tablet (1 tablet b.i.d. p.o.)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
Time Frame: Baseline, Week 4
The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Baseline, Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 4
Time Frame: Baseline, Week 4
The hives (wheals) severity score, defined by number of hives, will be recorded by the participant twice daily in their eCOA device, on a scale of 0 (none) to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.
Baseline, Week 4
Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 4
Time Frame: Baseline, Week 4
The severity of the itch will be recorded by the participant twice daily in their eCOA device, on a scale of 0 (none) to 3 (severe). A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 - 21.
Baseline, Week 4
Improvement of UAS7, assessed as absolute change from baseline in UAS7 score at Week 1
Time Frame: Baseline, Week 1
The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Baseline, Week 1
Percentage of participants with UAS7 ≤ 6 at Week 4
Time Frame: Week 4
Percentage of participants who achieved UAS7 ≤ 6 at Week 4. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Week 4
Percentage of participants with UAS7=0 at Week 4
Time Frame: Week 4
Percentage of participants who achieved UAS7 = 0 at Week 4. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Week 4
Percentage of participants with UAS7 ≤ 6 at Week 2
Time Frame: Week 2
Percentage of participants who achieved UAS7 ≤ 6 at Week 2. The UAS7 is the sum of the Weekly Hives Severity (HSS7) score and the Weekly Itch Severity (ISS7) score, and ranges from 0-42. Weekly scores (HSS7 and ISS7 scores) will be derived by adding up the average daily scores of the 7 days preceding the visit.
Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2025

Primary Completion (Estimated)

February 22, 2027

Study Completion (Estimated)

May 17, 2027

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOU064AUS02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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