ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT06868212
Public ClinicalTrials.gov record NCT06868212. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06868212
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
- Remibrutinib Drug
- Remibrutinib matching placebo Drug
- Dupilumab Drug
- Placebo solution for injection Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 10, 2025
- Primary completion
- Feb 21, 2027
- Completion
- May 16, 2027
- Last update posted
- Aug 18, 2026
2025 – 2027
United States locations
- U.S. sites
- 132
- U.S. states
- 35
- U.S. cities
- 107
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | Recruiting |
| Cahaba Derm and skin hlth ctr 27 | Birmingham | Alabama | 35244 | Recruiting |
| Research Solutions of Arizona | Litchfield Park | Arizona | 85340 | Recruiting |
| Peak Dermatology | Payson | Arizona | 85541 | Recruiting |
| Premier Allergy Asthma And Immunology | Phoenix | Arizona | 85032 | Recruiting |
| Avacare Center for Dermatology | Phoenix | Arizona | 85044 | Withdrawn |
| Orso Health | Scottsdale | Arizona | 85254 | Recruiting |
| Clin Trial Inst of Northwest AR | Fayetteville | Arkansas | 72703 | Recruiting |
| Acuro Research Inc | Little Rock | Arkansas | 72205 | Recruiting |
| First OC Dermatology | Fountain Valley | California | 92708 | Recruiting |
| Ctr for Dermatology Clinical Res | Fremont | California | 95438 | Recruiting |
| Allergy and Asthma Specialists Group | Huntington Beach | California | 92647 | Recruiting |
| Orso Health | Long Beach | California | 90808 | Recruiting |
| Ark Clinical Research | Long Beach | California | 90815 | Recruiting |
| California Allergy and Asthma Medical Group | Los Angeles | California | 90025 | Recruiting |
| Dermatology Research Associates | Los Angeles | California | 90045 | Recruiting |
| One Of A Kind Clinical Research | Napa | California | 94558 | Recruiting |
| Stanford University Medical Center | Palo Alto | California | 94304 | Recruiting |
| Empire Clinical Research | Pomona | California | 91767 | Recruiting |
| Allergy and Asthma Consultants | Redwood City | California | 94063 | Recruiting |
| Norcal Clinical Research | Rocklin | California | 95765 | Recruiting |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | Recruiting |
| Integrative Skin Science and Res | Sacramento | California | 95815 | Recruiting |
| UC Davis Neuromuscular Research Center | Sacramento | California | 95817 | Recruiting |
| Therapeutics Clinical Research | San Diego | California | 92123 | Recruiting |
| Dermatology Institute and Skin Care | Santa Monica | California | 90403 | Recruiting |
| Integrated Research of Inland Inc | Upland | California | 91786 | Recruiting |
| Allergy and Asthma Clin Res Inc | Walnut Creek | California | 94598 | Recruiting |
| University of Colorado Hospital - Aurora | Aurora | Colorado | 80045 | Recruiting |
| Asthma and Allergy Associates P C | Colorado Springs | Colorado | 80907 | Recruiting |
| Colorado ENT and Allergy | Colorado Springs | Colorado | 80909 | Recruiting |
| Skylight Health Res Inc Color Spr | Colorado Springs | Colorado | 80917 | Recruiting |
| UCONN Health Dermatology | Farmington | Connecticut | 06030-2840 | Recruiting |
| Howard University Hospital Division of Geriatrics | Washington D.C. | District of Columbia | 20059 | Recruiting |
| Florida Ctr Allergy Asthma Research | Aventura | Florida | 33180 | Recruiting |
| Skin Care Research Inc | Boca Raton | Florida | 33486 | Recruiting |
| Omnicure Clinical Research | Doral | Florida | 33172 | Recruiting |
| FXM Clinical Research Ft Laud | Fort Lauderdale | Florida | 33308 | Recruiting |
| Skin Care Research LLC | Hollywood | Florida | 33021 | Recruiting |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | Recruiting |
| University of MiamiHealth System | Miami | Florida | 33125 | Recruiting |
| FXM Clinical Res Miami LLC | Miami | Florida | 33175 | Recruiting |
| Miami Dade Medical Research | Miami | Florida | 33176 | Recruiting |
| FXM Clin Res Miramar LLC | Miramar | Florida | 33027 | Recruiting |
| Ziaderm Research LLC | North Miami Beach | Florida | 33162 | Recruiting |
| AllerVie Health | Panama | Florida | 32405 | Recruiting |
| Sarasota Clinical Research | Sarasota | Florida | 34233 | Recruiting |
| Lenus Research and Med Group LLC | Sweetwater | Florida | 33172 | Recruiting |
| Olympian Clinical Research | Tampa | Florida | 33609 | Recruiting |
| Asthma Allergy Immunology Clin Res | Tampa | Florida | 33613 | Recruiting |
| Conquest Research | Winter Park | Florida | 32789 | Recruiting |
| AllerVie Clin Res Columbus GA | Columbus | Georgia | 31904 | Recruiting |
| Cleaver Medical Group | Cumming | Georgia | 30040 | Recruiting |
| Southeast Dermatology Specialists | Douglasville | Georgia | 30135 | Recruiting |
| Aeroallergy Research Laboratories | Savannah | Georgia | 31406 | Recruiting |
| The Allergy Group-Meridian Clinic | Meridian | Idaho | 83642 | Recruiting |
| NW Uni C and T Sciences Ins | Chicago | Illinois | 60611 | Recruiting |
| Rush University Medical Center | Chicago | Illinois | 60612 | Recruiting |
| Midwest Allergy Sinus Asthma SC | Normal | Illinois | 61761 | Recruiting |
| Clinical Res Ctr of S Illinois | O'Fallon | Illinois | 62269 | Recruiting |
| Asthma and Allergy Center of Chicago S C | River Forest | Illinois | 60305 | Recruiting |
| Endeavor Health Clinical Trials Center | Skokie | Illinois | 60077 | Recruiting |
| Accellacare Duly Health and Care | Wheaton | Illinois | 60189 | Recruiting |
| Deaconess Clin Allerg Res Inst | Evansville | Indiana | 47715 | Recruiting |
| Southern IN Clinical Trials | New Albany | Indiana | 47150 | Recruiting |
| McFarland Clinic PC | Ames | Iowa | 50010 | Recruiting |
| Equity Medical LLC | Bowling Green | Kentucky | 42104 | Recruiting |
| Family Allergy And Asthma Rsch Inst | Louisville | Kentucky | 40215 | Recruiting |
| Allergy and Asthma Specialist P S C | Owensboro | Kentucky | 42301 | Recruiting |
| Ochsner Health Center | Baton Rouge | Louisiana | 70816 | Recruiting |
| Velocity Clinical Research | Lafayette | Louisiana | 70508 | Recruiting |
| Johns Hopkins U School of Med | Baltimore | Maryland | 21205 | Recruiting |
| Chesapeake Clinical Research Inc | Baltimore | Maryland | 21236 | Recruiting |
| Institute for Asthma and Allergy PC | Chevy Chase | Maryland | 20815 | Recruiting |
| AllerVie Clin Res Glenn Dale | Glenn Dale | Maryland | 20769 | Withdrawn |
| Boston Specialists LLC | Boston | Massachusetts | 02111 | Recruiting |
| Brigham And Womens Hospital | Boston | Massachusetts | 02115 | Withdrawn |
| ClinSite Inc | Ann Arbor | Michigan | 48106-0525 | Recruiting |
| Derm Institute West Michigan PLLC | Caledonia | Michigan | 49316 | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Recruiting |
| Revival Research Institute | Troy | Michigan | 48084 | Recruiting |
| Somerset Skin Centre | Troy | Michigan | 48084 | Recruiting |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Recruiting |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | Recruiting |
| ENT and Allergy Center of Missouri | Columbia | Missouri | 65201 | Recruiting |
| The Clinical Research Center | St Louis | Missouri | 63141 | Recruiting |
| Washington University | St Louis | Missouri | 63141 | Recruiting |
| Somnos Clinical Research | Lincoln | Nebraska | 68510 | Recruiting |
| Allergy and Asthma Center of Las Vegas | Las Vegas | Nevada | 89128 | Recruiting |
| Las Vegas Dermatology | Las Vegas | Nevada | 89144 | Recruiting |
| Hudson Essex Allergy-Circuit Clinical | Belleville | New Jersey | 07109 | Recruiting |
| Circuit Clinical Mercer Algy Pulm | Hamilton | New Jersey | 08619 | Recruiting |
| Allergy Asthma Assoc Monmouth | Little Silver | New Jersey | 07739 | Recruiting |
| Allergy Partners of New Jersey PC | Ocean Township | New Jersey | 07712 | Recruiting |
| Circuit Clinical | Riverdale | New Jersey | 07457 | Recruiting |
| Equity Medical | The Bronx | New York | 10455 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| Allergy Partners Of West NC | Asheville | North Carolina | 28801 | Recruiting |
| UNC DermatologyandSkinCancer Ctr | Chapel Hill | North Carolina | 27516 | Recruiting |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | Recruiting |
| CR Services Acquisition US | Columbus | Ohio | 43213 | Recruiting |
| Optimed Research LLC | Columbus | Ohio | 43235 | Withdrawn |
| Wright State University | Fairborn | Ohio | 45324 | Recruiting |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | Recruiting |
| Unity Clinical Research | Oklahoma City | Oklahoma | 73118 | Recruiting |
| Vital Prospects Clinical Research Institute | Tulsa | Oklahoma | 74136 | Recruiting |
| Oregon Medical Research Center | Portland | Oregon | 97223 | Recruiting |
| Oregon Health Sciences University | Portland | Oregon | 97239 | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | Recruiting |
| Medical Univ Of SC Medical Ctr | Charleston | South Carolina | 29425 | Recruiting |
| Tribe Clinical Research LLC | Greenville | South Carolina | 29601 | Recruiting |
| Allergic Disease and Asthma Center | Greenville | South Carolina | 29607 | Recruiting |
| Charleston ENT and Allergy | North Charleston | South Carolina | 29406 | Recruiting |
| National Allergy and Asthma Research LLS | North Charleston | South Carolina | 29420 | Recruiting |
| Goodlettsville Dermatology Research | Goodlettsville | Tennessee | 37072-2301 | Recruiting |
| International Clinical Research Tennessee LCC | Murfreesboro | Tennessee | 37130 | Recruiting |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | Recruiting |
| Orion Clinical Research | Austin | Texas | 78759 | Recruiting |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | Recruiting |
| Reveal Research Institute | Dallas | Texas | 75230 | Recruiting |
| Pharma Research and Amp Consult | Dallas | Texas | 75231 | Recruiting |
| Western Sky Medical Research | El Paso | Texas | 79924 | Recruiting |
| Center for Clinical Studies | Houston | Texas | 77030 | Recruiting |
| Sante Clinical Research | Kerrville | Texas | 78028 | Recruiting |
| RFSA Dermatology | San Antonio | Texas | 78213 | Recruiting |
| Andante Research | San Antonio | Texas | 78229 | Recruiting |
| University Of Utah | Murray | Utah | 84107 | Recruiting |
| Allergy Associates of Utah | Sandy City | Utah | 84093 | Recruiting |
| Forefront Dermatology | Vienna | Virginia | 22182 | Recruiting |
| Bellingham Asthma Allergy and Immunology | Bellingham | Washington | 98225 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06868212, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06868212 live on ClinicalTrials.gov.