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A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT07219615•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age:
•1. 18 years of age or older (or the minimum legal adult age as defined per local regulations, whichever is greater) at screening.
•Disease Characteristics:
•2. Participants must meet the following Chronic Spontaneous Urticaria (CSU) criteria:
•a. Chronic spontaneous urticaria diagnosis for ≥3 months at the time of screening (with the onset date assessed by the Investigator based on all available records) b. Diagnosis of CSU inadequately controlled by second generation antihistamine (sgAH) at the time of randomization, defined as: (i) The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of sgAH during this time period.
•(ii) Participants must have been on a sgAH at locally approved dose or higher for treatment of CSU for at least 7 consecutive days before screening assessment of UAS7 and ISS7 is initiated.
•(iii) Urticaria Activity Score 7 (UAS7) ≥16 (range 0-42) and an Itch Severity Score 7 (ISS7) ≥8 (range: 0-21) during the 7 days prior to randomization Day 1 c. Participants must complete at least 5 Urticaria Activity Score (UAS) eDiary entries during the 7 days immediately preceding randomization (Day 1) to confirm eligibility. If this requirement is not met due to documented, limited circumstances such as technical issues or short-term illness, the screening period may be extended only for the number of days necessary to allow completion of 5 UAS entries within any 7-day window. This extension period must not exceed 7 days.
•d. Anti-Immunoglobulin E-naïve (IgE-naïve) and Anti-Immunoglobulin E-experienced (Anti-IgE-experienced) participants. Anti-IgE-experienced participants are defined as meeting any of the following criteria confirmed by the Site Investigator: (i) Did not adequately respond to the approved dosage of an anti-IgE therapy (eg, omalizumab 300 mg Q4W or an alternate approved anti-IgE therapy) for at least 3 months, as assessed by the Investigator (ii) Could not tolerate an anti-IgE therapy (iii) Stopped an anti-IgE therapy for any reason, eg, loss of access e. Anti-IgE-experienced participants must have stopped anti-IgE therapy for at least 16 weeks, or 5 half-lives, whichever is longer, prior to randomization Day 1

Exclusion Criteria

•Medical Conditions:
•1. Medical conditions pertaining to CSU and other diseases/conditions affecting the skin
•* Urticaria is solely due to inducible urticaria.
•* Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms, including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to Complement 1 (C1) inhibitor deficiency).
•* Any other active skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigold, dermatitis herpetiformis, senile pruritus, etc.).
•2. History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
•3. General Infection History:
•* Having a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.
•* Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1.
•* Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
+20 more criteria

Locations (2)

Revival Research Institute, LLC

Troy, Michigan, United States

Allergy, Asthma and Clinical Research

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

October 30, 2025

Primary Completion Date

December 25, 2026

Completion Date

April 23, 2027

Last Updated

November 12, 2025

Enrollment

200

ESTIMATED participants

Conditions

Chronic Spontaneous Urticaria

Interventions

Ritlecitinib 50 mg

DRUG

Ritlecitinib 100 mg

DRUG

Placebo - 50 mg

DRUG

Placebo - 100 mg

DRUG

Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

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