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

Conditions

• Chronic Spontaneous Urticaria

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ritlecitinib 50 mg — DRUG
  50 mg Capsule
• Ritlecitinib 100 mg — DRUG
  100 mg Capsule
• Placebo - 50 mg — DRUG
  Matching Capsule
• Placebo - 100 mg — DRUG
  Matching Capsule

Study Details

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.

Key Dates

Start date

Oct 30, 2025

Status verified

Apr 2026

Primary completion

Dec 25, 2026

Completion

Apr 23, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  Randomized to Ritlecitinib 50 mg for 24 weeks Periods A and B). In addition to the active Ritlecitinib 50 mg capsule, a placebo matching the Ritlecitinib 100 mg capsule will be given to maintain blind
• Experimental: Arm 2
  Randomized to Ritlecitinib 100 mg for 24 weeks (Periods A and B). In addition to the active Ritlecitinib 100 mg capsule, a placebo matching the Ritlecitinib 50 mg capsule will be given to maintain blind
• Placebo Comparator: Arm 3
  Randomized to placebos matching the Ritlecitinib 50 mg and Ritlecitinib 100 mg capsules will be given to maintain blind from Day 1 to Week 12 (Period A). From Week 12 to Week 24 (Period B), will be switched to Ritlecitinib 100 mg. In addition to the active Ritlecitinib 100 mg capsule, a placebo matching the Ritlecitinib 50 mg capsule will be given to maintain blind.

Primary Outcome Measure

Change from baseline in Urticaria Activity Score 7 (UAS7) at Week 12 [ Time Frame: Week 12 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (11)

Find similar trials in Little Rock, AR

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