Sponsor:
Novartis Pharmaceuticals
Code:
NCT06868212
Conditions
Chronic Spontaneous Urticaria (CSU)
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Remibrutinib
Remibrutinib matching placebo
Dupilumab
Placebo solution for injection
Brief summary:
Conditions
Chronic Spontaneous Urticaria (CSU)
Study ID
NCT06868212
Start date
Jul 11, 2025
Status verified date
Aug, 2026
Completion date
May 17, 2027
Anticipated
Primary completion date
Feb 22, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
400 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
experimental: Treatment group 1: Remibrutinib + Placebo
active comparator: Treatment group 2: Dupilumab + remibrutinib matching placebo
Interventions
Remibrutinib
Remibrutinib matching placebo
Dupilumab
Placebo solution for injection
Primary outcome measure
Central contacts
Locations
Allervie Clinical Research
Recruiting
Birmingham, Alabama, United States, 35209
Contacts
Principal Investigator:
Weily Soong
Cahaba Derm and skin hlth ctr 27
Recruiting
Birmingham, Alabama, United States, 35244
Contacts
Principal Investigator:
Vlada Groysman
Research Solutions of Arizona
Recruiting
Litchfield Park, Arizona, United States, 85340
Contacts
Principal Investigator:
Connie Hsu
Peak Dermatology
Recruiting
Payson, Arizona, United States, 85541
Contacts
Principal Investigator:
Christopher Rex
Premier Allergy Asthma And Immunology
Recruiting
Phoenix, Arizona, United States, 85032
Contacts
Principal Investigator:
Kiranjit Khalsa
Orso Health
Recruiting
Scottsdale, Arizona, United States, 85254
Contacts
Hanna Varytska
hvarytska@orso-health.comPrincipal Investigator:
Jennifer Hill
Clin Trial Inst of Northwest AR
Recruiting
Fayetteville, Arkansas, United States, 72703
Contacts
Principal Investigator:
Mildred Clifton
Acuro Research Inc
Recruiting
Little Rock, Arkansas, United States, 72205
Contacts
Principal Investigator:
Karl Sitz
First OC Dermatology
Recruiting
Fountain Valley, California, United States, 92708
Contacts
Principal Investigator:
Vivian Laquer
Ctr for Dermatology Clinical Res
Recruiting
Fremont, California, United States, 95438
Contacts
Principal Investigator:
Sunil Dhawan
Allergy and Asthma Specialists Group
Recruiting
Huntington Beach, California, United States, 92647
Contacts
Principal Investigator:
Steven F Weinstein
Orso Health
Recruiting
Long Beach, California, United States, 90808
Contacts
Brenda Hann
bhann@orso-health.comPrincipal Investigator:
Steven M Meltzer
Ark Clinical Research
Recruiting
Long Beach, California, United States, 90815
Contacts
Jesus Gutierrez
jgutierrez@arkclinicalresearch.comPrincipal Investigator:
Kenneth Kim
California Allergy and Asthma Medical Group
Recruiting
Los Angeles, California, United States, 90025
Contacts
Principal Investigator:
Ricardo Tan
Dermatology Research Associates
Recruiting
Los Angeles, California, United States, 90045
Contacts
Principal Investigator:
Howard Lee Sofen
One Of A Kind Clinical Research
Recruiting
Napa, California, United States, 94558
Contacts
Principal Investigator:
Sam Ahn
Stanford University Medical Center
Recruiting
Palo Alto, California, United States, 94304
Contacts
Summer Zhu
szhuye@stanford.eduPrincipal Investigator:
Meng Chen
Empire Clinical Research
Recruiting
Pomona, California, United States, 91767
Contacts
Principal Investigator:
Radhika Shah
Allergy and Asthma Consultants
Recruiting
Redwood City, California, United States, 94063
Contacts
Sherry Lipson
sherry.lipsonallergy@gmail.comPrincipal Investigator:
Brian Lipson
Norcal Clinical Research
Recruiting
Rocklin, California, United States, 95765
Contacts
Olutokunbo Onadeko
olutokunbo@norcalclinicalresearch.comPrincipal Investigator:
Maulik Dhanda
Peninsula Research Associates
Recruiting
Rolling Hills Estates, California, United States, 90274
Contacts
Principal Investigator:
Lawrence D Sher
Integrative Skin Science and Res
Recruiting
Sacramento, California, United States, 95815
Contacts
Hailey Rietz Rietz
hailey@integrativeskinresearch.comPrincipal Investigator:
Raja Sivamani
UC Davis Neuromuscular Research Center
Recruiting
Sacramento, California, United States, 95817
Contacts
Jordan Nava
jonava@health.ucdavis.eduPrincipal Investigator:
Emanual Maverakis
Therapeutics Clinical Research
Recruiting
San Diego, California, United States, 92123
Contacts
Principal Investigator:
Neal Bhatia
Dermatology Institute and Skin Care
Recruiting
Santa Monica, California, United States, 90403
Contacts
Principal Investigator:
Paul Yamauchi
Integrated Research of Inland Inc
Recruiting
Upland, California, United States, 91786
Contacts
Alma Gonzalez
alma@irgriverside.comPrincipal Investigator:
Amit I Patel
Allergy and Asthma Clin Res Inc
Recruiting
Walnut Creek, California, United States, 94598
Contacts
Principal Investigator:
Joshua S Jacobs
University of Colorado Hospital - Aurora
Recruiting
Aurora, Colorado, United States, 80045
Contacts
Principal Investigator:
Jenny Stitt
Asthma and Allergy Associates P C
Recruiting
Colorado Springs, Colorado, United States, 80907
Contacts
Principal Investigator:
Daniel Soteres
Colorado ENT and Allergy
Recruiting
Colorado Springs, Colorado, United States, 80909
Contacts
Principal Investigator:
Eric Caplan
Skylight Health Res Inc Color Spr
Recruiting
Colorado Springs, Colorado, United States, 80917
Contacts
Kachi Obeke
kachi.obeke@skylighthealthresearch.comPrincipal Investigator:
David Greenstein
UCONN Health Dermatology
Recruiting
Farmington, Connecticut, United States, 06030-2840
Contacts
Ektor Rafti
erafti@uchc.eduPrincipal Investigator:
Jun Lu
Howard University Hospital Division of Geriatrics
Recruiting
Washington D.C., District of Columbia, United States, 20059
Contacts
Edward Bauer
edward.bauer1@howard.eduPrincipal Investigator:
Carla Davis
Florida Ctr Allergy Asthma Research
Recruiting
Aventura, Florida, United States, 33180
Contacts
Principal Investigator:
Ileana Rodicio
Florida Ctr Allergy Asthma Research
Recruiting
Aventura, Florida, United States, 33180
Contacts
Principal Investigator:
Jaime Landman
Skin Care Research Inc
Recruiting
Boca Raton, Florida, United States, 33486
Contacts
Principal Investigator:
Ann Reed
Omnicure Clinical Research
Recruiting
Doral, Florida, United States, 33172
Contacts
Principal Investigator:
Alan Kaufman
FXM Clinical Research Ft Laud
Recruiting
Fort Lauderdale, Florida, United States, 33308
Contacts
Maritza D Diego
maritza.d.diego@fxmresearch.comPrincipal Investigator:
Igor Chaplik
Skin Care Research LLC
Recruiting
Hollywood, Florida, United States, 33021
Contacts
Principal Investigator:
Eduardo Weiss
Jacksonville Center for Clinical Research
Recruiting
Jacksonville, Florida, United States, 32216
Contacts
Principal Investigator:
Steve Dorman
University of MiamiHealth System
Recruiting
Miami, Florida, United States, 33125
Contacts
Felierix Castro Palmero
fxc609@med.miami.eduPrincipal Investigator:
Gil Yosipovitch
FXM Clinical Res Miami LLC
Recruiting
Miami, Florida, United States, 33175
Contacts
Maritza D Diego
maritza.d.diego@fxmresearch.comPrincipal Investigator:
Hector Wiltz
Miami Dade Medical Research
Recruiting
Miami, Florida, United States, 33176
Contacts
Principal Investigator:
Vicente Chavarria
FXM Clin Res Miramar LLC
Recruiting
Miramar, Florida, United States, 33027
Contacts
Maritza D Diego
maritza.d.diego@fxmresearch.comPrincipal Investigator:
Francisco Flores
Ziaderm Research LLC
Recruiting
North Miami Beach, Florida, United States, 33162
Contacts
Principal Investigator:
Tory Sullivan
AllerVie Health
Recruiting
Panama, Florida, United States, 32405
Contacts
Lauren Green
lgreen@allervie.comPrincipal Investigator:
Maxcie Sikora
Sarasota Clinical Research
Recruiting
Sarasota, Florida, United States, 34233
Contacts
Principal Investigator:
Hugh Harmon Windom
Lenus Research and Med Group LLC
Recruiting
Sweetwater, Florida, United States, 33172
Contacts
Principal Investigator:
John Niven
Olympian Clinical Research
Recruiting
Tampa, Florida, United States, 33609
Contacts
Principal Investigator:
Matthew Zook
Asthma Allergy Immunology Clin Res
Recruiting
Tampa, Florida, United States, 33613
Contacts
Principal Investigator:
Amber N Pepper
Conquest Research
Recruiting
Winter Park, Florida, United States, 32789
Contacts
Principal Investigator:
Michael Wangia
AllerVie Clin Res Columbus GA
Recruiting
Columbus, Georgia, United States, 31904
Contacts
Principal Investigator:
Robert R Chrzanowski
Cleaver Medical Group
Recruiting
Cumming, Georgia, United States, 30040
Contacts
Principal Investigator:
Weston Waxweiler
Southeast Dermatology Specialists
Recruiting
Douglasville, Georgia, United States, 30135
Contacts
Taylor Harrell
tharrell@sedsderm.comPrincipal Investigator:
Firas Hougeir
Aeroallergy Research Laboratories
Recruiting
Savannah, Georgia, United States, 31406
Contacts
Principal Investigator:
Bruce Finkel
The Allergy Group-Meridian Clinic
Recruiting
Meridian, Idaho, United States, 83642
Contacts
Principal Investigator:
Neetu Talreja
NW Uni C and T Sciences Ins
Recruiting
Chicago, Illinois, United States, 60611
Contacts
Tiffany Valcarcel
tiffany.valcarcel@northwestern.eduPrincipal Investigator:
Anju T Peters
Rush University Medical Center
Recruiting
Chicago, Illinois, United States, 60612
Contacts
Principal Investigator:
James N. Moy
Midwest Allergy Sinus Asthma SC
Recruiting
Normal, Illinois, United States, 61761
Contacts
Principal Investigator:
Dareen D Siri
Clinical Res Ctr of S Illinois
Recruiting
O'Fallon, Illinois, United States, 62269
Contacts
Principal Investigator:
Patrick Win
Asthma and Allergy Center of Chicago S C
Recruiting
River Forest, Illinois, United States, 60305
Contacts
Principal Investigator:
Rachna Shah
Endeavor Health Clinical Trials Center
Recruiting
Skokie, Illinois, United States, 60077
Contacts
Principal Investigator:
Giselle Mosnaim
Accellacare Duly Health and Care
Recruiting
Wheaton, Illinois, United States, 60189
Contacts
Sammer Javed
sammer.javed@accellacare.comPrincipal Investigator:
James Herrmann
Deaconess Clin Allerg Res Inst
Recruiting
Evansville, Indiana, United States, 47715
Contacts
Principal Investigator:
Anne Mclaughlin
Southern IN Clinical Trials
Recruiting
New Albany, Indiana, United States, 47150
Contacts
Misty Humphress
mhumphress@soinct.comPrincipal Investigator:
Megan Landis
McFarland Clinic PC
Recruiting
Ames, Iowa, United States, 50010
Contacts
Principal Investigator:
Jason Allen Cascio
Equity Medical LLC
Recruiting
Bowling Green, Kentucky, United States, 42104
Contacts
Alyssa Nesmith
anesmith@equity-med.comPrincipal Investigator:
David Johnson
Family Allergy And Asthma Rsch Inst
Recruiting
Louisville, Kentucky, United States, 40215
Contacts
Principal Investigator:
James Wesley Sublett
Allergy and Asthma Specialist P S C
Recruiting
Owensboro, Kentucky, United States, 42301
Contacts
Principal Investigator:
Lee Clore
Ochsner Health Center
Recruiting
Baton Rouge, Louisiana, United States, 70816
Contacts
Principal Investigator:
Kelser Bourgoyne
Velocity Clinical Research
Recruiting
Lafayette, Louisiana, United States, 70508
Contacts
Principal Investigator:
Jibran Atwi
Johns Hopkins U School of Med
Recruiting
Baltimore, Maryland, United States, 21205
Contacts
Principal Investigator:
Eric Tyrell Oliver
Chesapeake Clinical Research Inc
Recruiting
Baltimore, Maryland, United States, 21236
Contacts
Geri Novak
gnovak.ccr@gmail.comPrincipal Investigator:
Jonathan Matz
Institute for Asthma and Allergy PC
Recruiting
Chevy Chase, Maryland, United States, 20815
Contacts
Andrew Kim
iaaresearchak@gmail.comPrincipal Investigator:
Mark Scarupa
Boston Specialists LLC
Recruiting
Boston, Massachusetts, United States, 02111
Contacts
Lina Fikri
lina.f@bfac.orgPrincipal Investigator:
John Leung
ClinSite Inc
Recruiting
Ann Arbor, Michigan, United States, 48106-0525
Contacts
Principal Investigator:
Rajan Ravikumar
Derm Institute West Michigan PLLC
Recruiting
Caledonia, Michigan, United States, 49316
Contacts
Cathy Wolters
cwolters@derminstituteofwmi.comPrincipal Investigator:
Kristi B Hawley
Henry Ford Hospital
Recruiting
Detroit, Michigan, United States, 48202
Contacts
Principal Investigator:
Alan Baptist
Revival Research Institute
Recruiting
Troy, Michigan, United States, 48084
Contacts
Principal Investigator:
Ali Moiin
Somerset Skin Centre
Recruiting
Troy, Michigan, United States, 48084
Contacts
Principal Investigator:
George Murakawa
Clinical Research Institute
Recruiting
Minneapolis, Minnesota, United States, 55402
Contacts
Principal Investigator:
Hemalini Mehta
University of Minnesota
Recruiting
Minneapolis, Minnesota, United States, 55455
Contacts
Thomas Pritchard
pritc204@umn.eduPrincipal Investigator:
Paul Bigliardi
Mayo Clinic - Rochester
Recruiting
Rochester, Minnesota, United States, 55905
Contacts
Principal Investigator:
Gerald Volcheck
ENT and Allergy Center of Missouri
Recruiting
Columbia, Missouri, United States, 65201
Contacts
Principal Investigator:
Christine Franzese
The Clinical Research Center
Recruiting
St Louis, Missouri, United States, 63141
Contacts
Principal Investigator:
Jeffrey Tillinghast
Washington University
Recruiting
St Louis, Missouri, United States, 63141
Contacts
Principal Investigator:
Maya Jerath
Somnos Clinical Research
Recruiting
Lincoln, Nebraska, United States, 68510
Contacts
Principal Investigator:
Robert J Szalewski
Allergy and Asthma Center of Las Vegas
Recruiting
Las Vegas, Nevada, United States, 89128
Contacts
Principal Investigator:
Jason Bellak
Las Vegas Dermatology
Recruiting
Las Vegas, Nevada, United States, 89144
Contacts
Principal Investigator:
David Graham Cotter
Hudson Essex Allergy-Circuit Clinical
Recruiting
Belleville, New Jersey, United States, 07109
Contacts
Melba Ventura
mventura@circuitclinical.comPrincipal Investigator:
Mark Edward Weinstein
Circuit Clinical Mercer Algy Pulm
Recruiting
Hamilton, New Jersey, United States, 08619
Contacts
Luis Paredes
lparedes@circuitclinical.comPrincipal Investigator:
Peter Ricketti
Allergy Asthma Assoc Monmouth
Recruiting
Little Silver, New Jersey, United States, 07739
Contacts
Principal Investigator:
Tina Zecca
Allergy Partners of New Jersey PC
Recruiting
Ocean Township, New Jersey, United States, 07712
Contacts
Lynnette Whitten
Lynnette.whitten@allergypartners.comPrincipal Investigator:
Ellen Sher
Circuit Clinical
Recruiting
Riverdale, New Jersey, United States, 07457
Contacts
Principal Investigator:
Jeffrey Weiss
Equity Medical
Recruiting
The Bronx, New York, United States, 10455
Contacts
Jennie Mata
jmata@equity-med.comPrincipal Investigator:
Alissa McInerney
Montefiore Medical Center
Recruiting
The Bronx, New York, United States, 10467
Contacts
Principal Investigator:
Golda Hudes
Allergy Partners Of West NC
Recruiting
Asheville, North Carolina, United States, 28801
Contacts
Principal Investigator:
David M Cypcar
UNC DermatologyandSkinCancer Ctr
Recruiting
Chapel Hill, North Carolina, United States, 27516
Contacts
Principal Investigator:
Donna Culton
Bernstein Clinical Research Center
Recruiting
Cincinnati, Ohio, United States, 45231
Contacts
Principal Investigator:
Jonathan Abram Bernstein
CR Services Acquisition US
Recruiting
Columbus, Ohio, United States, 43213
Contacts
Principal Investigator:
Sridhar Guduri
Wright State University
Recruiting
Fairborn, Ohio, United States, 45324
Contacts
Principal Investigator:
Craig Rohan
Toledo Institute of Clinical Research
Recruiting
Toledo, Ohio, United States, 43617
Contacts
Principal Investigator:
Syed Rehman
Unity Clinical Research
Recruiting
Oklahoma City, Oklahoma, United States, 73118
Contacts
Principal Investigator:
Jarad Levin
Vital Prospects Clinical Research Institute
Recruiting
Tulsa, Oklahoma, United States, 74136
Contacts
Principal Investigator:
Iftikhar Hussain
Oregon Medical Research Center
Recruiting
Portland, Oregon, United States, 97223
Contacts
Principal Investigator:
Jason Hawkes
Oregon Health Sciences University
Recruiting
Portland, Oregon, United States, 97239
Contacts
Principal Investigator:
Shyam Joshi
University of Pittsburgh Medical Center
Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contacts
Principal Investigator:
Merritt Lynn Fajt
Allergy and Clinical Immunology Associates
Recruiting
Pittsburgh, Pennsylvania, United States, 15241
Contacts
Principal Investigator:
Michael Palumbo
Medical Univ Of SC Medical Ctr
Recruiting
Charleston, South Carolina, United States, 29425
Contacts
Principal Investigator:
Kelli Williams
Tribe Clinical Research LLC
Recruiting
Greenville, South Carolina, United States, 29601
Contacts
Karleigh Williams
kwilliams@tribecr.comPrincipal Investigator:
James Kuhlen
Allergic Disease and Asthma Center
Recruiting
Greenville, South Carolina, United States, 29607
Contacts
Principal Investigator:
Neil L Kao
Charleston ENT and Allergy
Recruiting
North Charleston, South Carolina, United States, 29406
Contacts
Amanda Jones
ajones@charlestonent.comPrincipal Investigator:
Thomas Murphy
National Allergy and Asthma Research LLS
Recruiting
North Charleston, South Carolina, United States, 29420
Contacts
Principal Investigator:
John T Ramey
Goodlettsville Dermatology Research
Recruiting
Goodlettsville, Tennessee, United States, 37072-2301
Contacts
Principal Investigator:
Keith H Loven
International Clinical Research Tennessee LCC
Recruiting
Murfreesboro, Tennessee, United States, 37130
Contacts
Principal Investigator:
Christina Feser
Arlington Center for Dermatology
Recruiting
Arlington, Texas, United States, 76011
Contacts
Principal Investigator:
Angela Moore
Orion Clinical Research
Recruiting
Austin, Texas, United States, 78759
Contacts
Principal Investigator:
William Howland III
Bellaire Dermatology Associates
Recruiting
Bellaire, Texas, United States, 77401
Contacts
Principal Investigator:
Craig F Teller
Reveal Research Institute
Recruiting
Dallas, Texas, United States, 75230
Contacts
Jade Conway
jconway@revealinstitute.comPrincipal Investigator:
Aaron Farberg
Pharma Research and Amp Consult
Recruiting
Dallas, Texas, United States, 75231
Contacts
Principal Investigator:
Gary Gross
Western Sky Medical Research
Recruiting
El Paso, Texas, United States, 79924
Contacts
Principal Investigator:
Todd Funkhouser
Center for Clinical Studies
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
Stephen K Tyring
Sante Clinical Research
Recruiting
Kerrville, Texas, United States, 78028
Contacts
Danielle Monclova
dmonclova@santeresearch.netPrincipal Investigator:
Dale E Mohar
RFSA Dermatology
Recruiting
San Antonio, Texas, United States, 78213
Contacts
Jonathan Joseph
jonathanj.rfsadermatology@gmail.comPrincipal Investigator:
Lindsey Finklea
Andante Research
Recruiting
San Antonio, Texas, United States, 78229
Contacts
Kevin Ramirez
kramirez@andanteresearch.comPrincipal Investigator:
Robert Ramirez
University Of Utah
Recruiting
Murray, Utah, United States, 84107
Contacts
Rebecca Jones
rebecca.jones@hsc.utah.eduPrincipal Investigator:
Christopher Hull
Allergy Associates of Utah
Recruiting
Sandy City, Utah, United States, 84093
Contacts
Principal Investigator:
Andrew M Smith
Forefront Dermatology
Recruiting
Vienna, Virginia, United States, 22182
Contacts
Jacqueline Henley
jacqueline.henley@forefrontderm.comPrincipal Investigator:
Naiem Issa
Bellingham Asthma Allergy and Immunology
Recruiting
Bellingham, Washington, United States, 98225
Contacts
Principal Investigator:
David Elkayam
Sponsor
Novartis Pharmaceuticals
Last update posted
Aug 19, 2026
Last verified
Aug, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-19.