The VALOR Study is a Phase 3, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of oral brepocitinib in adults with dermatomyositis

Priovant Therapeutics is currently sponsoring a Phase 3, double-blind, placebo-controlled clinical research study of the investigational medicine brepocitinib in adults with dermatomyositis who have both muscle and skin disease involvement and are currently or in the past have had an inadequate response (or are intolerant to) corticosteroids and/or immunomodulators.

Brepocitinib is an orally bioavailable small molecule tyrosine kinase (TYK)2/Janus kinase (JAK)1 inhibitor. Through dual inhibition of TYK2 and JAK1, brepocitinib is expected to reduce the activity of cytokines that have signaling pathways mediated by these 2 kinases, including type I interferons, interferon-gamma, and several interleukins, which have been implicated in the pathogenesis of dermatomyositis.

The primary objective of this study is to evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on Total Improvement Score after 52 weeks of brepocitinib administration once daily in comparison to placebo.
Following a screening period of up to 8 weeks, eligible participants will be randomized 1:1:1 to take oral brepocitinib 30 mg, brepocitinib 15 mg, or placebo once a day for 52 weeks. Upon completion of the Blinded Treatment Period, participants will enter a 4-week safety Follow-up Period or a separate extension study.

Please see below for more information on the study and click here to open a list of clinical trial sites in a new browser tab.

design

 The VALOR Study is a Phase 3, randomized, double-blind, placebo-controlled study. The study lasts up to 64 weeks with about 13 visits (visit frequency is approximately every 4 to 6 weeks).

Screening Period

Up to 8 weeks

At least 1 visit

Blinded Treatment Period

52 weeks

11 visits

Off-Drug Follow-up Period*

4 weeks

1 visit

 *This visit is not required for participants who enroll in the separate extension study

Primary Objective

To evaluate the efficacy of brepocitinib for the treatment of dermatomyositis based on Total Improvement Score (TIS) after 52 weeks of brepocitinib administration once daily in comparison to placebo

Primary Endpoints

TIS at Week 52. TIS is a composite endpoint based on the following 6 Disease Activity Core Set Measure scores, and ranges from 0 to 100 (2016 ACR/EULAR Myositis Response Criteria):

  • Physician Global Activity-VAS
  • Patient Global Activity-VAS
  • Manual Muscle Testing in 8 muscles (MMT-8)
  • Health Assessment Questionnaire Disability Index
  • Muscle Enzyme Assessment
  • Extramuscular Global Assessment-VAS
population
  • Adults ≥ 18 to < 75 years of age
  • Diagnosis of dermatomyositis according to EULAR/ACR criteria
  • MMT-8 score ≥ 80 and ≤ 142 and active cutaneous manifestation of dermatomyositis CDASI Activity Score ≥ 6
  • Currently or in the past have had an inadequate response (or are intolerant to) stable dose of corticosteroids (prednisone or equivalent), hydroxychloroquine and/or non-steroid immunomodulatory/immunosuppressive therapy
dosage

Participants will be randomized 1:1:1 to 1 of the following 3 intervention groups:

  • Arm 1: brepocitinib 30 mg
  • Arm 2: brepocitinib 15 mg
  • Arm 3: placebo

The study drug is administered orally as a combination of 3 tablets (containing either 5 mg or 25 mg brepocitinib or matching placebo) once daily for 52 weeks

 ACR = American College of Rheumatology; EULAR = European League Against Rheumatism; VAS = visual analogue scale

If you would like to refer a patient or request further information, please use the contact form below

By referring patients, you are neither requiring them to participate nor guaranteeing their enrollment.

© 2022 All rights reserved. Priovant Therapeutics, Inc.