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

ClinicalTrials.gov ID: NCT07219615

Public ClinicalTrials.gov record NCT07219615. 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.

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ClinicalTrials.gov public records Last synced Sep 12, 2026, 12:03 AM EDT

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Official title

A PHASE 2B RANDOMIZED, DOUBLE-BLIND, 12-WEEK PLACEBO-CONTROLLED STUDY WITH A 12-WEEK DOUBLE-BLIND EXTENSION PERIOD TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH CHRONIC SPONTANEOUS URTICARIA

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 placebo will be switched to 100mg for an additional 12 weeks (Period B). The 2 doses of ritlecitinib in this study will be compared to each other and to the placebo. This will help to see if the 50 mg and/or 100 mg dose of ritlecitinib is safe and effective. Participants will be in this study for about 8 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: * Physical examinations, * Hearing tests, * Blood tests, * X-ray, * ECG (electrocardiogram), * Participants will also be asked to complete questionnaires every day about their chronic spontaneous urticaria in an electronic diary.

Study identification

NCT ID: NCT07219615
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Pfizer; Industry
Enrollment: 200 participants

Conditions and interventions

Conditions

Chronic Spontaneous Urticaria

Interventions

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: Oct 29, 2025
Primary completion: Dec 24, 2026
Completion: Apr 22, 2027
Last update posted: Jun 16, 2026

2025 – 2027

United States locations

U.S. sites: 15
U.S. states: 9
U.S. cities: 15

Facility	City	State	ZIP	Site status
Saguaro Dermatology - Phoenix	Phoenix	Arizona	85008	Not yet recruiting
Acuro Research, Inc.	Little Rock	Arkansas	72205	Recruiting
Kern Research. Inc.	Bakersfield	California	93301	Recruiting
First OC Dermatology Research Inc	Fountain Valley	California	92708	Recruiting
Antelope Valley Clinical Trials	Lancaster	California	93534	Recruiting
Skin & Beauty Center - Pasadena	Pasadena	California	91105	Recruiting
Asthma and Allergy Associates, PC	Colorado Springs	Colorado	80907	Recruiting
Asthma and Allergy Center of Chicago	River Forest	Illinois	60305	Recruiting
Chesapeake Clinical Research	White Marsh	Maryland	21162	Recruiting
University of Michigan	Ann Arbor	Michigan	48109	Recruiting
Revival Research Institute, LLC	Troy	Michigan	48084	Recruiting
Allergy, Asthma, & Clinical Research Center	Oklahoma City	Oklahoma	73120	Recruiting
Orion Clinical Research	Austin	Texas	78759	Recruiting
RFSA Dermatology - San Antonio - West Avenue	San Antonio	Texas	78213	Recruiting
Complete Dermatology	Sugar Land	Texas	77479	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07219615, 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 Jun 16, 2026 · Synced Sep 12, 2026

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