Phase 3 enrollment completed for study evaluating brepocitinib in dermatomyositis

Key takeaways:

• The phase 3 study will evaluate brepocitinib’s efficacy and safety for the treatment of dermatomyositis.
• A total of 241 subjects have been enrolled.
• Results are expected in the second half of 2025.

Enrollment in the phase 3 VALOR study evaluating brepocitinib for the treatment of dermatomyositis has been completed, Priovant Therapeutics announced in a press release.

Dermatomyositis, a multi-organ idiopathic inflammatory condition characterized by debilitating muscle weakness and skin lesions, affects an approximate 40,000 U.S. adults. The condition can also cause large rashes on the skin and impact organ function, particularly the lungs.

With the only approved therapies for dermatomyositis being steroidal products and intravenous immunoglobulin, patients and practitioners hope for other options.

In the double-blind, placebo-controlled VALOR study, 241 subjects across 90 sites in four continents have been enrolled for the evaluation of brepocitinib, a once-daily, oral dual selective tyrosine kinase 2 and Janus kinase 1 inhibitor.

Subjects in the double-blind study will be randomly assigned 1:1:1 to receive brepocitinib 30 mg, brepocitinib 15 mg or placebo. The primary endpoint will be a total improvement score at 52 weeks, whereas secondary endpoints include additional measurements of skin and muscle disease, measurements of disease activity and organs, the benefits of steroid-free treatment and quality of life outcomes.

According to the release, data will be released in the second half of 2025 and may be followed by a new drug application submission.

“We deeply appreciate the time and commitment of the patients, investigators and site research staff who enable this important work,” Ben Zimmer, JD, CEO of Priovant, said in the release. “We look forward to providing further updates as we reach upcoming milestones in 2024 and 2025.”