New pill shows promise for stubborn hives in Head-to-Head trial

NCT ID NCT06868212

Symptom relief Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study tests a new daily pill (remibrutinib) against a standard injected drug (dupilumab) for adults with chronic hives that antihistamines can't control. About 400 participants will take either the pill or get the shot for 4 weeks to see which works faster. The goal is to reduce itching and hives quickly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic spontaneous urticaria (CSU)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

129 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Accellacare Duly Health and Care
RECRUITING

Wheaton, Illinois, 60189, United States
Acuro Research Inc
RECRUITING

Little Rock, Arkansas, 72205, United States
Aeroallergy Research Laboratories
RECRUITING

Savannah, Georgia, 31406, United States
AllerVie Clin Res Columbus GA
RECRUITING

Columbus, Georgia, 31904, United States
AllerVie Clin Res Glenn Dale
WITHDRAWN

Glenn Dale, Maryland, 20769, United States
AllerVie Health
RECRUITING

Panama, Florida, 32405, United States
Allergic Disease and Asthma Center
RECRUITING

Greenville, South Carolina, 29607, United States
Allergy Associates of Utah
RECRUITING

Sandy City, Utah, 84093, United States
Allergy Asthma Assoc Monmouth
RECRUITING

Little Silver, New Jersey, 07739, United States
Allergy Partners Of West NC
RECRUITING

Asheville, North Carolina, 28801, United States
Allergy Partners of New Jersey PC
RECRUITING

Ocean Township, New Jersey, 07712, United States
Allergy and Asthma Center of Las Vegas
RECRUITING

Las Vegas, Nevada, 89128, United States
Allergy and Asthma Clin Res Inc
RECRUITING

Walnut Creek, California, 94598, United States
Allergy and Asthma Consultants
RECRUITING

Redwood City, California, 94063, United States
Allergy and Asthma Specialist P S C
RECRUITING

Owensboro, Kentucky, 42301, United States
Allergy and Asthma Specialists Group
RECRUITING

Huntington Beach, California, 92647, United States
Allergy and Clinical Immunology Associates
RECRUITING

Pittsburgh, Pennsylvania, 15241, United States
Allervie Clinical Research
RECRUITING

Birmingham, Alabama, 35209, United States
Andante Research
RECRUITING

San Antonio, Texas, 78229, United States
Ark Clinical Research
RECRUITING

Long Beach, California, 90815, United States
Arlington Center for Dermatology
RECRUITING

Arlington, Texas, 76011, United States
Asthma Allergy Immunology Clin Res
RECRUITING

Tampa, Florida, 33613, United States
Asthma and Allergy Associates P C
RECRUITING

Colorado Springs, Colorado, 80907, United States
Asthma and Allergy Center of Chicago S C
RECRUITING

River Forest, Illinois, 60305, United States
Avacare Center for Dermatology
WITHDRAWN

Phoenix, Arizona, 85044, United States
Bellaire Dermatology Associates
RECRUITING

Bellaire, Texas, 77401, United States
Bellingham Asthma Allergy and Immunology
RECRUITING

Bellingham, Washington, 98225, United States
Bernstein Clinical Research Center
RECRUITING

Cincinnati, Ohio, 45231, United States
Boston Specialists LLC
RECRUITING

Boston, Massachusetts, 02111, United States
Brigham And Womens Hospital
WITHDRAWN

Boston, Massachusetts, 02115, United States
CR Services Acquisition US
RECRUITING

Columbus, Ohio, 43213, United States
Cahaba Derm and skin hlth ctr 27
RECRUITING

Birmingham, Alabama, 35244, United States
California Allergy and Asthma Medical Group
RECRUITING

Los Angeles, California, 90025, United States
Center for Clinical Studies
RECRUITING

Houston, Texas, 77030, United States
Charleston ENT and Allergy
RECRUITING

North Charleston, South Carolina, 29406, United States
Chesapeake Clinical Research Inc
RECRUITING

Baltimore, Maryland, 21236, United States
Circuit Clinical
RECRUITING

Riverdale, New Jersey, 07457, United States
Circuit Clinical Mercer Algy Pulm
RECRUITING

Hamilton, New Jersey, 08619, United States
Cleaver Medical Group
RECRUITING

Cumming, Georgia, 30040, United States
Clin Trial Inst of Northwest AR
RECRUITING

Fayetteville, Arkansas, 72703, United States
ClinSite Inc
RECRUITING

Ann Arbor, Michigan, 48106-0525, United States
Clinical Res Ctr of S Illinois
RECRUITING

O'Fallon, Illinois, 62269, United States
Clinical Research Institute
RECRUITING

Minneapolis, Minnesota, 55402, United States
Colorado ENT and Allergy
RECRUITING

Colorado Springs, Colorado, 80909, United States
Conquest Research
RECRUITING

Winter Park, Florida, 32789, United States
Ctr for Dermatology Clinical Res
RECRUITING

Fremont, California, 95438, United States
Deaconess Clin Allerg Res Inst
RECRUITING

Evansville, Indiana, 47715, United States
Derm Institute West Michigan PLLC
RECRUITING

Caledonia, Michigan, 49316, United States
Dermatology Institute and Skin Care
RECRUITING

Santa Monica, California, 90403, United States
Dermatology Research Associates
RECRUITING

Los Angeles, California, 90045, United States
ENT and Allergy Center of Missouri
RECRUITING

Columbia, Missouri, 65201, United States
Empire Clinical Research
RECRUITING

Pomona, California, 91767, United States
Endeavor Health Clinical Trials Center
RECRUITING

Skokie, Illinois, 60077, United States
Equity Medical
RECRUITING

The Bronx, New York, 10455, United States
Equity Medical LLC
RECRUITING

Bowling Green, Kentucky, 42104, United States
FXM Clin Res Miramar LLC
RECRUITING

Miramar, Florida, 33027, United States
FXM Clinical Res Miami LLC
RECRUITING

Miami, Florida, 33175, United States
FXM Clinical Research Ft Laud
RECRUITING

Fort Lauderdale, Florida, 33308, United States
Family Allergy And Asthma Rsch Inst
RECRUITING

Louisville, Kentucky, 40215, United States
First OC Dermatology
RECRUITING

Fountain Valley, California, 92708, United States
Florida Ctr Allergy Asthma Research
RECRUITING

Aventura, Florida, 33180, United States
Florida Ctr Allergy Asthma Research
RECRUITING

Aventura, Florida, 33180, United States
Forefront Dermatology
RECRUITING

Vienna, Virginia, 22182, United States
Goodlettsville Dermatology Research
RECRUITING

Goodlettsville, Tennessee, 37072-2301, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States
Howard University Hospital Division of Geriatrics
RECRUITING

Washington D.C., District of Columbia, 20059, United States
Hudson Essex Allergy-Circuit Clinical
RECRUITING

Belleville, New Jersey, 07109, United States
Institute for Asthma and Allergy PC
RECRUITING

Chevy Chase, Maryland, 20815, United States

Contact Email: •••••@•••••
Integrated Research of Inland Inc
RECRUITING

Upland, California, 91786, United States
Integrative Skin Science and Res
RECRUITING

Sacramento, California, 95815, United States
International Clinical Research Tennessee LCC
RECRUITING

Murfreesboro, Tennessee, 37130, United States
Jacksonville Center for Clinical Research
RECRUITING

Jacksonville, Florida, 32216, United States
Johns Hopkins U School of Med
RECRUITING

Baltimore, Maryland, 21205, United States
Las Vegas Dermatology
RECRUITING

Las Vegas, Nevada, 89144, United States
Lenus Research and Med Group LLC
RECRUITING

Sweetwater, Florida, 33172, United States
Mayo Clinic - Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
McFarland Clinic PC
RECRUITING

Ames, Iowa, 50010, United States
Medical Univ Of SC Medical Ctr
RECRUITING

Charleston, South Carolina, 29425, United States
Miami Dade Medical Research
RECRUITING

Miami, Florida, 33176, United States
Midwest Allergy Sinus Asthma SC
RECRUITING

Normal, Illinois, 61761, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
NW Uni C and T Sciences Ins
RECRUITING

Chicago, Illinois, 60611, United States
National Allergy and Asthma Research LLS
RECRUITING

North Charleston, South Carolina, 29420, United States
Norcal Clinical Research
RECRUITING

Rocklin, California, 95765, United States
Ochsner Health Center
RECRUITING

Baton Rouge, Louisiana, 70816, United States
Olympian Clinical Research
RECRUITING

Tampa, Florida, 33609, United States
Omnicure Clinical Research
RECRUITING

Doral, Florida, 33172, United States
One Of A Kind Clinical Research
RECRUITING

Napa, California, 94558, United States
Optimed Research LLC
WITHDRAWN

Columbus, Ohio, 43235, United States
Oregon Health Sciences University
RECRUITING

Portland, Oregon, 97239, United States
Oregon Medical Research Center
RECRUITING

Portland, Oregon, 97223, United States
Orion Clinical Research
RECRUITING

Austin, Texas, 78759, United States
Orso Health
RECRUITING

Scottsdale, Arizona, 85254, United States
Orso Health
RECRUITING

Long Beach, California, 90808, United States
Peak Dermatology
RECRUITING

Payson, Arizona, 85541, United States
Peninsula Research Associates
RECRUITING

Rolling Hills Estates, California, 90274, United States
Pharma Research and Amp Consult
RECRUITING

Dallas, Texas, 75231, United States
Premier Allergy Asthma And Immunology
RECRUITING

Phoenix, Arizona, 85032, United States
RFSA Dermatology
RECRUITING

San Antonio, Texas, 78213, United States
Research Solutions of Arizona
RECRUITING

Litchfield Park, Arizona, 85340, United States
Reveal Research Institute
RECRUITING

Dallas, Texas, 75230, United States
Revival Research Institute
RECRUITING

Troy, Michigan, 48084, United States
Rush University Medical Center
RECRUITING

Chicago, Illinois, 60612, United States
Sante Clinical Research
RECRUITING

Kerrville, Texas, 78028, United States
Sarasota Clinical Research
RECRUITING

Sarasota, Florida, 34233, United States

Contact Email: •••••@•••••
Skin Care Research Inc
RECRUITING

Boca Raton, Florida, 33486, United States
Skin Care Research LLC
RECRUITING

Hollywood, Florida, 33021, United States
Skylight Health Res Inc Color Spr
RECRUITING

Colorado Springs, Colorado, 80917, United States
Somerset Skin Centre
RECRUITING

Troy, Michigan, 48084, United States
Somnos Clinical Research
RECRUITING

Lincoln, Nebraska, 68510, United States
Southeast Dermatology Specialists
RECRUITING

Douglasville, Georgia, 30135, United States
Southern IN Clinical Trials
RECRUITING

New Albany, Indiana, 47150, United States
Stanford University Medical Center
RECRUITING

Palo Alto, California, 94304, United States
The Allergy Group-Meridian Clinic
RECRUITING

Meridian, Idaho, 83642, United States
The Clinical Research Center
RECRUITING

St Louis, Missouri, 63141, United States
Therapeutics Clinical Research
RECRUITING

San Diego, California, 92123, United States
Toledo Institute of Clinical Research
RECRUITING

Toledo, Ohio, 43617, United States
Tribe Clinical Research LLC
RECRUITING

Greenville, South Carolina, 29601, United States
UC Davis Neuromuscular Research Center
RECRUITING

Sacramento, California, 95817, United States
UCONN Health Dermatology
RECRUITING

Farmington, Connecticut, 06030-2840, United States
UNC DermatologyandSkinCancer Ctr
RECRUITING

Chapel Hill, North Carolina, 27516, United States
Unity Clinical Research
RECRUITING

Oklahoma City, Oklahoma, 73118, United States
University Of Utah
RECRUITING

Murray, Utah, 84107, United States
University of Colorado Hospital - Aurora
RECRUITING

Aurora, Colorado, 80045, United States
University of MiamiHealth System
RECRUITING

Miami, Florida, 33125, United States
University of Minnesota
RECRUITING

Minneapolis, Minnesota, 55455, United States
University of Pittsburgh Medical Center
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
Velocity Clinical Research
RECRUITING

Lafayette, Louisiana, 70508, United States
Vital Prospects Clinical Research Institute
RECRUITING

Tulsa, Oklahoma, 74136, United States
Washington University
RECRUITING

St Louis, Missouri, 63141, United States
Western Sky Medical Research
RECRUITING

El Paso, Texas, 79924, United States
Wright State University
RECRUITING

Fairborn, Ohio, 45324, United States
Ziaderm Research LLC
RECRUITING

North Miami Beach, Florida, 33162, United States

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