New Clinical Trial Data Published for Ritlecitinib

Results from a clinical trial for a new treatment for alopecia areata were published in the medical journal The Lancet on 4/13/23. The publication reports on the evaluation of ritlecitinib, an experimental medication developed by Pfizer.

The late-stage clinical trial (Phase 2b-3) evaluated how safe and effective ritlecitinib was among 718 patients who have alopecia areata with 50% or more scalp hair loss. The international trial  took place in 18 countries, including the U.S. and Canada. Participants in the trial included adults and adolescents, ages 12 and up. The study examined the effectiveness of ritlecitinib at different doses and dosing patterns in achieving hair regrowth.

The researchers found that after 24 weeks, participants who took 30 mg or 50 mg of ritlecitinib daily experienced significant hair regrowth compared to patients who took a placebo. Between 14% and 31% of patients in the different treatment groups reached the study endpoint, which was 20% or less scalp hair loss. In addition, the percentage of patients achieving or exceeding the study endpoint increased as treatment continued to 48 weeks.

Ritlecitinib is an oral medication and a member of a class of drugs known as JAK inhibitors. These drugs block cellular signals thought to interfere with the immune attack on hair follicles that occurs with alopecia areata. Ritlecitinib is an inhibitor of JAK3 and the TEC kinase family.

Based on the trial results, the study authors concluded that ritlecitinib has an acceptable safety profile and is effective in treating alopecia areata. The drug is currently under review by the U.S. Food and Drug Administration (FDA) and a decision is expected during the second quarter of 2023.

Dr. Brett King, the study’s lead author, is a member of NAAF’s Board of Directors. Other study authors include two NAAF Research Advisory Council members, Dr. Jerry Shapiro and Dr. Natasha Mesinkovska.

Learn more:

An infographic summary of the study results from The Lancet is available here.

Read a plain language summary of the ritlecitinib clinical trial results.

A video abstract of the study from The Lancet is available here.

In addition, a text summary of The Lancet research publication is available here.