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Study identifier: NCT07219615 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.

Condition: Chronic Spontaneous Urticaria  ·  Sponsor: Pfizer

PhasePhase 2
Planned participants200
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of chronic spontaneous urticaria (CSU) that is not effectively treated by antihistamines which are used to stop the body's "allergy alarm system" from overreacting. Chronic spontaneous urticaria is a disease that causes itchy hives and swellings in the deep layers of skin and fatty tissue just underneath the skin that come and go without a clear reason. This study will look at both the 50 milligrams (mg) once daily (QD) oral dose and 100 milligrams (mg) once daily (QD) oral dose and compare them to placebo (pill with no active medicine). This study is seeking participants who: * Are 18 years of age or older * Have a diagnosis of chronic spontaneous urticaria for 3 months or more that has not been controlled well with antihistamine treatment. * Do not have any other skin conditions associated with chronic itching or itching caused mainly by known triggers. * Are willing to stop all other treatments that they may be taking for chronic spontaneous urticaria other than a second-generation antihistamine (sgAH). About 150 participants will take part in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive either the 50 mg dose or 100 mg dose or placebo, taken by mouth once daily for 12 weeks( Period A). Thereafter the participants on 50 mg and 100 mg will continue on their doses while the participants receiving …

This description comes directly from the study's public registry record.

Talk to the study team

Pfizer CT.gov Call Center  ·  1-800-718-1021  ·  ClinicalTrials.gov_Inquiries@pfizer.com

Always discuss trial participation with your own doctor first.

Locations (69)

Saguaro Dermatology - PhoenixPhoenix, Arizona, United StatesNot Yet Recruiting
Acuro Research, Inc.Little Rock, Arkansas, United StatesRecruiting
Kern Research. Inc.Bakersfield, California, United StatesRecruiting
First OC Dermatology Research IncFountain Valley, California, United StatesRecruiting
Antelope Valley Clinical TrialsLancaster, California, United StatesRecruiting
Skin & Beauty Center - PasadenaPasadena, California, United StatesRecruiting
Asthma and Allergy Associates, PCColorado Springs, Colorado, United StatesRecruiting
Asthma and Allergy Center of ChicagoRiver Forest, Illinois, United StatesRecruiting
Chesapeake Clinical ResearchWhite Marsh, Maryland, United StatesRecruiting
University of MichiganAnn Arbor, Michigan, United StatesRecruiting
Revival Research Institute, LLCTroy, Michigan, United StatesRecruiting
Allergy, Asthma, & Clinical Research CenterOklahoma City, Oklahoma, United StatesRecruiting

+ 57 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07219615