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Active, not recruitingPhase 3

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

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Ames, Ann Arbor, Arlington, Asheville, Aurora, Austin, Aventura, Baltimore, Baton Rouge, Bellaire, Bellingham, Birmingham, Boca Raton, Boston, Bowling Green, Caledonia, Chapel Hill, Chevy Chase, Chicago, Cincinnati, Colorado Springs, Columbia, Columbus, Cumming, Dallas, Detroit, Doral, Douglasville, El Paso, Evansville, Fairborn, Fort Lauderdale, Fountain Valley, Fremont, Goodlettsville, Greenville, Hamilton, Hollywood, Houston, Huntington Beach, Jacksonville, Kerrville, Lafayette, Las Vegas, Lincoln, Litchfield Park, Little Rock, Little Silver, Long Beach, Los Angeles, Louisville, Meridian, Miami, Minneapolis, Miramar, Murfreesboro, Murray, Napa, New Albany, Normal, North Charleston, North Miami Beach, O'Fallon, Ocean Township, Oklahoma City, Owensboro, Palo Alto, Panama, Payson, Phoenix, Pittsburgh, Pomona, Portland, Redwood City, River Forest, Rochester, Rocklin, Rolling Hills Estates, Sacramento, San Antonio, San Diego, Sandy City, Santa Monica, Sarasota, Savannah, Scottsdale, Skokie, St Louis, Sweetwater, Tampa, The Bronx, Toledo, Troy, Tulsa, Upland, Vienna, Walnut Creek, Washington D.C., Wheaton, and Winter Park, United StatesSee the 121 sites
Trial code
Status
Active, not recruiting
Phase
Phase 3
People taking part
409 people enrolled
Started
11 Jul 2025
Expected to end
17 May 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Remibrutinib
  • Remibrutinib matching placebo
  • Dupilumab
  • Placebo solution for injection
Record updated
9 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants [NOAC])
  • 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
  • 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

Where in United States

  • McFarland Clinic, PCAmes, United States
  • ClinSite IncAnn Arbor, United States
  • Arlington Center for DermatologyArlington, United States
  • Allergy Partners Of West NCAsheville, United States
  • University of Colorado Hospital - AuroraAurora, United States
  • Orion Clinical ResearchAustin, United States
  • Florida Ctr Allergy Asthma ResearchAventura, United States
  • Chesapeake Clinical Research IncBaltimore, United States
  • Johns Hopkins U School of MedBaltimore, United States
  • Ochsner Health CenterBaton Rouge, United States
  • Bellaire Dermatology AssociatesBellaire, United States
  • Bellingham Asthma Allergy and ImmunologyBellingham, United States
  • AllerVie Clinical ResearchBirmingham, United States
  • Cahaba Derm and skin hlth ctr 27Birmingham, United States
  • Skin Care Research, IncBoca Raton, United States
  • Boston Specialists LLCBoston, United States
  • Equity Medical, LLCBowling Green, United States
  • Derm Institute West Michigan PLLCCaledonia, United States
  • UNC DermatologyandSkinCancer CtrChapel Hill, United States
  • Institute for Asthma and Allergy PCChevy Chase, United States
  • NW Uni C and T Sciences InsChicago, United States
  • Rush University Medical CenterChicago, United States
  • Bernstein Clinical Research CenterCincinnati, United States
  • Asthma and Allergy Associates P CColorado Springs, United States
  • Colorado ENT and AllergyColorado Springs, United States
  • ENT and Allergy Center of MissouriColumbia, United States
  • AllerVie Clin Res Columbus GAColumbus, United States
  • CR Services Acquisition USColumbus, United States
  • Cleaver Medical GroupCumming, United States
  • Pharma Research and Amp ConsultDallas, United States
  • Reveal Research InstituteDallas, United States
  • Henry Ford HospitalDetroit, United States
  • Omnicure Clinical ResearchDoral, United States
  • Southeast Dermatology SpecialistsDouglasville, United States
  • Western Sky Medical ResearchEl Paso, United States
  • Deaconess Clin Allerg Res InstEvansville, United States
  • Wright State UniversityFairborn, United States
  • FXM Clinical Research Ft LaudFort Lauderdale, United States
  • First OC DermatologyFountain Valley, United States
  • Ctr for Dermatology Clinical ResFremont, United States
  • Goodlettsville Dermatology ResearchGoodlettsville, United States
  • Allergic Disease and Asthma CenterGreenville, United States
  • Tribe Clinical Research LLCGreenville, United States
  • Circuit Clinical Mercer Algy PulmHamilton, United States
  • Skin Care Research, LlcHollywood, United States
  • Center for Clinical StudiesHouston, United States
  • Allergy and Asthma Specialists GroupHuntington Beach, United States
  • Jacksonville Center for Clinical ResearchJacksonville, United States
  • Sante Clinical ResearchKerrville, United States
  • Velocity Clinical ResearchLafayette, United States
  • Allergy and Asthma Center of Las VegasLas Vegas, United States
  • Las Vegas DermatologyLas Vegas, United States
  • Somnos Clinical ResearchLincoln, United States
  • Research Solutions of ArizonaLitchfield Park, United States
  • Acuro Research, IncLittle Rock, United States
  • Allergy Asthma Assoc MonmouthLittle Silver, United States
  • Ark Clinical ResearchLong Beach, United States
  • Orso HealthLong Beach, United States
  • California Allergy and Asthma Medical GroupLos Angeles, United States
  • Dermatology Research AssociatesLos Angeles, United States
  • Family Allergy And Asthma Rsch InstLouisville, United States
  • The Allergy Group-Meridian ClinicMeridian, United States
  • FXM Clinical Res Miami LLCMiami, United States
  • Miami Dade Medical ResearchMiami, United States
  • University of MiamiHealth SystemMiami, United States
  • Clinical Research InstituteMinneapolis, United States
  • University of MinnesotaMinneapolis, United States
  • Eminat, LLCMiramar, United States
  • International Clinical Research Tennessee LCCMurfreesboro, United States
  • University of UtahMurray, United States
  • One Of A Kind Clinical ResearchNapa, United States
  • Southern IN Clinical TrialsNew Albany, United States
  • Midwest Allergy Sinus Asthma, SCNormal, United States
  • Charleston ENT and AllergyNorth Charleston, United States
  • National Allergy and Asthma Research LLSNorth Charleston, United States
  • Ziaderm Research LLCNorth Miami Beach, United States
  • Clinical Res Ctr of S IllinoisO'Fallon, United States
  • Allergy Partners of New Jersey PCOcean Township, United States
  • Unity Clinical ResearchOklahoma City, United States
  • Allergy and Asthma Specialist P S COwensboro, United States
  • Stanford University Medical CenterPalo Alto, United States
  • AllerVie HealthPanama, United States
  • Peak DermatologyPayson, United States
  • Premier Allergy Asthma And ImmunologyPhoenix, United States
  • Allergy and Clinical Immunology AssociatesPittsburgh, United States
  • University of Pittsburgh Medical CenterPittsburgh, United States
  • Empire Clinical ResearchPomona, United States
  • Oregon Health Sciences UniversityPortland, United States
  • Oregon Medical Research CenterPortland, United States
  • Allergy and Asthma ConsultantsRedwood City, United States
  • Asthma and Allergy Center of Chicago S CRiver Forest, United States
  • Mayo Clinic - RochesterRochester, United States
  • NorCal Clinical ResearchRocklin, United States
  • Peninsula Research AssociatesRolling Hills Estates, United States
  • Integrative Skin Science and ResSacramento, United States
  • UC Davis Neuromuscular Research CenterSacramento, United States
  • Andante ResearchSan Antonio, United States
  • RFSA DermatologySan Antonio, United States
  • Therapeutics Clinical ResearchSan Diego, United States
  • Allergy Associates of UtahSandy City, United States
  • Dermatology Institute and Skin CareSanta Monica, United States
  • Sarasota Clinical ResearchSarasota, United States
  • Aeroallergy Research LaboratoriesSavannah, United States
  • Orso HealthScottsdale, United States
  • Endeavor Health Clinical Trials CenterSkokie, United States
  • The Clinical Research CenterSt Louis, United States
  • Washington UniversitySt Louis, United States
  • Lenus Research and Med Group LLCSweetwater, United States
  • Asthma Allergy Immunology Clin ResTampa, United States
  • Equity MedicalThe Bronx, United States
  • Montefiore Medical CenterThe Bronx, United States
  • Toledo Institute of Clinical ResearchToledo, United States
  • Revival Research InstituteTroy, United States
  • Somerset Skin CentreTroy, United States
  • Vital Prospects Clinical Research InstituteTulsa, United States
  • Integrated Research of Inland, Inc.Upland, United States
  • Forefront DermatologyVienna, United States
  • Allergy and Asthma Clin Res IncWalnut Creek, United States
  • Howard University Hospital Division of GeriatricsWashington D.C., United States
  • Accellacare Duly Health and CareWheaton, United States
  • Conquest ResearchWinter Park, United States

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Treatment group 1: Remibrutinib + PlaceboTreatment being tested

    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 \[Weeks 2-10\])

    Treatment: Remibrutinib and Placebo solution for injection

  • Treatment group 2: Dupilumab + remibrutinib matching placeboExisting treatment, for comparison

    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.)

    Treatment: Remibrutinib matching placebo and Dupilumab

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Publications
Record updated
9 November 2026