Pfizer Launches Phase III Trial of JAK Inhibitor Ritlecitinib for Non-Segmental Vitiligo

On March 23, the Chinese Drug Clinical Trial Registration and Information Disclosure Platform showed that Pfizer initiated a Phase III clinical study (registration number CTR20230893) of Ritlecitinib capsules (Ritlecitinib) for the treatment of non-segmental vitiligo, aiming to evaluate the efficacy, safety, and tolerability of Ritlecitinib in adult and adolescent patients with non-segmental vitiligo.

This is a randomized, double-blind, placebo-controlled, multi-center Phase III study, planning to enroll 90 participants in China and 600 participants globally. Patients in the experimental group are required to take 50mg of Ritlecitinib orally once daily. The primary endpoints are the proportion of patients achieving a 75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI75) from baseline at Week 52, and the proportion of patients achieving a 50% improvement in the Total Vitiligo Area Scoring Index (T-VASI50) from baseline. Key secondary endpoints include the proportion of F-VASI75 at Weeks 24 and 36, the proportion of T-VASI50 at Week 24, and the PGIS-F and PGIS-V scores (assessing vitiligo severity) at Week 52.

Ritlecitinib is an oral Janus kinase 3 (JAK3) inhibitor that achieves JAK isoenzyme selective inhibition through covalent interaction with the unique residue CYS-909 of JAK3. Compared with first-generation pan-JAK inhibitors, this drug has advantages in reducing toxicity.

Vitiligo is a chronic autoimmune disease with a global prevalence of 0.5-2.0%. It is characterized by the loss of skin pigmentation due to the functional loss of melanocytes. It is divided into two main types: non-segmental vitiligo (NSV) and segmental vitiligo (SV), with generalized vitiligo and acrofacial vitiligo being the most common.

In July 2022, Incyte/Novartis's Ruxolitinib Cream Received FDA Approval for the Treatment of Vitiligo, Becoming the First Approved JAK Inhibitor for This Disease. Currently, the vitiligo indication for Rituximab has also progressed to Phase III clinical trials, making it the fastest progressing JAK inhibitor aside from Ruxolitinib.

In addition to vitiligo, clinical studies on ritlecitinib are being conducted in and outside of China for indications such as alopecia areata, ulcerative colitis, Crohn's disease, rheumatoid arthritis, and cicatricial alopecia. In September 2022, Pfizer submitted a new drug application for ritlecitinib for the treatment of alopecia areata in China, the U.S., and Europe (see details:).

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