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
NCT ID: NCT06868212
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-07-11
2027-05-17
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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 open label extension (OLE) period and receive remibrutinib (25 mg b.i.d. p.o.) for 12 weeks (up to Week 24).
TREATMENT
TRIPLE
Study Groups
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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 \[Weeks 2-10\])
Remibrutinib
Film-coated tablet, oral administration, 25 mg b.i.d.
Placebo solution for injection
Solution for injection in pre-filled syringe every 2 weeks
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.)
Remibrutinib matching placebo
Film-coated tablet, oral administration, b.i.d.
Dupilumab
Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks
Interventions
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Remibrutinib
Film-coated tablet, oral administration, 25 mg b.i.d.
Remibrutinib matching placebo
Film-coated tablet, oral administration, b.i.d.
Dupilumab
Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks
Placebo solution for injection
Solution for injection in pre-filled syringe every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Allervie Clinical Research
Birmingham, Alabama, United States
Cahaba Derm and skin hlth ctr 27
Birmingham, Alabama, United States
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Peak Dermatology
Payson, Arizona, United States
Premier Allergy Asthma And Immunology
Phoenix, Arizona, United States
Avacare Center for Dermatology
Phoenix, Arizona, United States
Orso Health
Scottsdale, Arizona, United States
Acuro Research Inc
Little Rock, Arkansas, United States
First OC Dermatology
Fountain Valley, California, United States
Ctr for Dermatology Clinical Res
Fremont, California, United States
Allergy and Asthma Specialists Group
Huntington Beach, California, United States
Orso Health
Long Beach, California, United States
Ark Clinical Research
Long Beach, California, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
One Of A Kind Clinical Research
Napa, California, United States
Empire Clinical Research
Pomona, California, United States
Allergy and Asthma Consultants
Redwood City, California, United States
Integrative Skin Science and Res
Sacramento, California, United States
UC Davis Neuromuscular Research Center
Sacramento, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Integrated Research of Inland Inc
Upland, California, United States
Allergy and Asthma Clin Res Inc
Walnut Creek, California, United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States
UCONN Health Dermatology
Farmington, Connecticut, United States
Howard University Hospital Division of Geriatrics
Washington D.C., District of Columbia, United States
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States
Florida Ctr Allergy Asthma Research
Aventura, Florida, United States
Skin Care Research Inc
Boca Raton, Florida, United States
Skin Care Research LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University of MiamiHealth System
Miami, Florida, United States
FXM Clinical Res Miami LLC
Miami, Florida, United States
Miami Dade Medical Research
Miami, Florida, United States
Eminat Research Group
Miramar, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
AllerVie Health
Panama, Florida, United States
Sarasota Clinical Research
Sarasota, Florida, United States
Lenus Research and Med Group LLC
Sweetwater, Florida, United States
Olympian Clinical Research
Tampa, Florida, United States
Asthma Allergy Immunology Clin Res
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
AllerVie Clin Res Columbus GA
Columbus, Georgia, United States
Cleaver Medical Group
Cumming, Georgia, United States
Southeast Dermatology Specialists
Douglasville, Georgia, United States
Aeroallergy Research Laboratories
Savannah, Georgia, United States
The Allergy Group-Meridian Clinic
Meridian, Idaho, United States
Northshore University Health System
Glenview, Illinois, United States
Midwest Allergy Sinus Asthma SC
Normal, Illinois, United States
Clinical Res Ctr of S Illinois
O'Fallon, Illinois, United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States
Deaconess Clin Allerg Res Inst
Evansville, Indiana, United States
Southern IN Clinical Trials
New Albany, Indiana, United States
Family Allergy And Asthma Rsch Inst
Louisville, Kentucky, United States
Allergy and Asthma Specialist P S C
Owensboro, Kentucky, United States
Ochsner Health Center
Baton Rouge, Louisiana, United States
Chesapeake Clinical Research Inc
Baltimore, Maryland, United States
AllerVie Clin Res Glenn Dale
Glenn Dale, Maryland, United States
Boston Specialists LLC
Boston, Massachusetts, United States
Derm Institute West Michigan PLLC
Caledonia, Michigan, United States
Revival Research Institute
Troy, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
The Clinical Research Center
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Las Vegas Dermatology
Las Vegas, Nevada, United States
Hudson Essex Allergy-Circuit Clinical
Belleville, New Jersey, United States
Circuit Clinical Mercer Algy Pulm
Hamilton, New Jersey, United States
Allergy Asthma Assoc Monmouth
Little Silver, New Jersey, United States
Circuit Clinical
Riverdale, New Jersey, United States
Equity Medical
The Bronx, New York, United States
UNC DermatologyandSkinCancer Ctr
Chapel Hill, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
CR Services Acquisition US
Columbus, Ohio, United States
Optimed Research LLC
Columbus, Ohio, United States
Wright State University
Fairborn, Ohio, United States
Toledo Institute of Clinical Research
Toledo, Ohio, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Tribe Clinical Research LLC
Greenville, South Carolina, United States
Allergic Disease and Asthma Center
Greenville, South Carolina, United States
Charleston ENT and Allergy
North Charleston, South Carolina, United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States
International Clinical Research Tennessee, LCC
Murfreesboro, Tennessee, United States
Arlington Center for Dermatology
Arlington, Texas, United States
Orion Clinical Research
Austin, Texas, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Reveal Research Institute
Dallas, Texas, United States
Pharma Research and Amp Consult
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
RFSA Dermatology
San Antonio, Texas, United States
Andante Research
San Antonio, Texas, United States
University Of Utah
Murray, Utah, United States
Allergy Associates of Utah
Sandy City, Utah, United States
Bellingham Asthma Allergy and Immunology
Bellingham, Washington, United States
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Abbey Patrick
Role: primary
Wes Booth
Role: primary
Role: primary
Olusola Oladipo
Role: primary
Jeruselem Rendon
Role: primary
Lindsey Arcuri
Role: primary
Hanna Varytska
Role: primary
Mindy Demarco
Role: primary
Nathan Tauta
Role: primary
Evguenia Vals
Role: primary
Kourtney Hutchinson
Role: primary
Karina Linares
Role: primary
Jesus Gutierrez
Role: primary
Clare Kanchana
Role: primary
Justin An
Role: primary
Michelle Humbard
Role: primary
Halley Torres
Role: primary
Sherry Lipson
Role: primary
Hailey Rietz Rietz
Role: primary
Jordan Nava
Role: primary
Avigail Cueto
Role: primary
Alma Gonzalez
Role: primary
Siddharth Sandhu
Role: primary
Lauren Utter
Role: primary
Ektor Rafti
Role: primary
Edward Bauer
Role: primary
Aixa Valdes
Role: primary
Alexandra Villa
Role: primary
Esther Perez
Role: primary
Lucy Vargas
Role: primary
Alexander Hill
Role: primary
Felierix Castro Palmero
Role: primary
Maritza D Diego
Role: primary
Stacy Machado
Role: primary
Maritza D Diego
Role: primary
Daine Velazco
Role: primary
Lauren Green
Role: primary
Sally A Kastes
Role: primary
Claudia Monteagudo
Role: primary
Ingrid Rodriguez
Role: primary
Megan Stonehocker
Role: primary
Sandy Pate
Role: primary
Victoria Sherer
Role: primary
Sofia Shamim
Role: primary
Taylor Harrell
Role: primary
Susie Gault
Role: primary
Stephanie Gil
Role: primary
Kelsey Hulen
Role: primary
Stephanie Oliver
Role: primary
Nichole Stonich
Role: primary
Emily Rodriguez
Role: primary
Brandi Burgdorf
Role: primary
Misty Humphress
Role: primary
Rebecca Whitehead
Role: primary
Angela Haynes
Role: primary
Magen Parker
Role: primary
Geri Novak
Role: primary
Chasity Nichols
Role: primary
Lina Fikri
Role: primary
Alexa Lum
Role: primary
Manali Ambegaonkar
Role: primary
Tiffany Rothenhauser
Role: primary
Amy Saykao
Role: primary
Thomas Pritchard
Role: primary
Jodi Mahon
Role: primary
Margaret Ellington
Role: primary
Megan Baldenweck
Role: primary
Faith Limon
Role: primary
Melba Ventura
Role: primary
Cynthia Pinargotte
Role: primary
Danielle Imperiale
Role: primary
Amanda Tellefsen
Role: primary
Courtnie Yokono
Role: primary
Michael Povelaitis
Role: primary
Karen J Berendts
Role: primary
Jyohaarika Nagilla
Role: primary
Tosha Heineman
Role: primary
Jessica Hong
Role: primary
Abbas Zaidi
Role: primary
Charlotte Tinsley
Role: primary
Ashley Brown
Role: primary
Megan Lamey
Role: primary
Lorenzo Redmond
Role: primary
Susan Shidel
Role: primary
Karleigh Williams
Role: primary
Elissa Peery
Role: primary
Amanda Jones
Role: primary
Faye Singleton
Role: primary
Andrew Garcia
Role: primary
Yariana Canini
Role: primary
Amber Ogden
Role: primary
Hannah Green
Role: primary
Redina Bardhi
Role: primary
Roxanne Garcia
Role: primary
Elisa Hernandez
Role: primary
Mario Guerrero
Role: primary
Danielle Monclova
Role: primary
Jonathan Joseph
Role: primary
Kevin Ramirez
Role: primary
Angela Contreras
Role: primary
Sandy Warr
Role: primary
Nancy Moore
Role: primary
Other Identifiers
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CLOU064AUS02
Identifier Type: -
Identifier Source: org_study_id