Study Evaluating Oral Ritlecitinib Doses Compared to Placebo for Adults With Chronic Spontaneous Urticaria Not Controlled by Antihistamines

What this Trial Is About

Researchers are evaluating the safety and effects of the medicine ritlecitinib for adults with chronic spontaneous urticaria CSU that is not well controlled by antihistamines. CSU causes itchy hives and swelling in the skin and fatty tissue without a clear cause. This phase 2 study aims to compare two oral doses of ritlecitinib, 50 mg and 100 mg, against a placebo to learn how well they work and their safety profiles. Participants will be randomly assigned to one of three groups taking 50 mg ritlecitinib, 100 mg ritlecitinib, or a placebo, each taken once daily by mouth for 12 weeks Period A. After this, those on ritlecitinib continue their doses for another 12 weeks Period B, while those initially on placebo switch to 100 mg ritlecitinib for the same duration. Placebo capsules matching the active doses will be given to maintain study blinding. Participants will be involved in the study for about 8 months and will visit the study site up to 9 times. During visits, they will have physical exams, hearing tests, blood tests, chest X-rays, and ECGs. They will also complete daily questionnaires about their symptoms using an electronic diary. The main outcome measured is the change in their urticaria activity score after 12 weeks, along with monitoring for any side effects or adverse events throughout the study.

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