A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (VALOR)

July 15, 2026 updated by: Priovant Therapeutics, Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Caba, Argentina, 1425
        • Clinical Trial Site
      • Mendoza, Argentina, 5519
        • Clinical Trial Site
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Clinical Trial Site
  • Belgium
      • Leuven, Belgium, 3000
        • Clinical Trial Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Clinical Trial Site
      • Plovdiv, Bulgaria, 4001
        • Clinical Trial Site
      • Plovdiv, Bulgaria, 4004
        • Clinical Trial Site
      • Sofia, Bulgaria, 1407
        • Clinical Trial Site
  • Canada
    • British Colombia
      • Vancouver, British Colombia, Canada, V5Y1K2
        • Clinical Trial Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Clinical Trial Site
  • Chile
      • Recoleta, Chile, 8420383
        • Clinical Trial Site
      • Santiago, Chile, 7640881
        • Clinical Trial Site
      • Santiago, Chile, 8331150
        • Clinical Trial Site
      • Temuco, Chile, 4800827
        • Clinical Trial Site
    • Biobio
      • Concepción, Biobio, Chile, 4070280
        • Clinical Trial Site
  • Czechia
      • Prague, Czechia, 128 00
        • Clinical Trial Site
  • Germany
      • Berlin, Germany, 10117
        • Clinical Trial Site
      • Berlin, Germany, 15562
        • Clinical Trial Site
      • Dresden, Germany, 01307
        • Clinical Trial Site
      • Essen, Germany, 45147
        • Clinical Trial Site
      • Freiburg im Breisgau, Germany, 79106
        • Clinical Trial Site
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Clinical Trial Site
  • Hungary
      • Debrecen, Hungary, 4032
        • Clinical Trial Site
      • Pécs, Hungary, 7632
        • Clinical Trial Site
      • Szeged, Hungary, 6720
        • Clinical Trial Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Clinical Trial Site
      • Haifa, Israel, 3109601
        • Clinical Trial Site
      • Poria – Neve Oved, Israel, 1528001
        • Clinical Trial Site
      • Tel Aviv, Israel, 6423906
        • Clinical Trial Site
      • Tel Litwinsky, Israel, 52621
        • Clinical Trial Site
  • Italy
      • Bari, Italy, 70126
        • Clinical Trial Site
      • Pavia, Italy, 27100
        • Clinical Trial Site
      • Roma, Italy, 00168
        • Clinical Trial Site
      • Torino, Italy, 10126
        • Clinical Trial Site
  • Mexico
      • Guadalajara, Mexico, 44690
        • Clinical Trial Site
      • Mexico City, Mexico, 06700
        • Clinical Trial Site
      • San Luis Potosí City, Mexico, 78290
        • Clinical Trial Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Clinical Trial Site
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Clinical Trial Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Clinical Trial Site
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Clinical Trial Site
  • Poland
      • Krakow, Poland, 30-363
        • Clinical Trial Site
      • Lublin, Poland, 20-400
        • Clinical Trial Site
      • Lublin, Poland, 20-607
        • Clinical Trial Site
      • Nowa Sól, Poland, 67-100
        • Clinical Trial Site
      • Poznan, Poland, 61-293
        • Clinical Trial Site
      • Warsaw, Poland, 02-637
        • Clinical Trial Site
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-704
        • Clinical Trial Site
  • Portugal
      • Guimarães, Portugal, 4835-044
        • Clinical Trial Site
      • Lisbon, Portugal, 1649-028
        • Clinical Trial Site
      • Porto, Portugal, 4099-001
        • Clinical Trial Site
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Clinical Trial Site
  • Romania
      • Bucharest, Romania, 011172
        • Clinical Trial Site
      • Cluj-Napoca, Romania, 400000
        • Clinical Trial Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Trial Site
  • South Korea
      • Seoul, South Korea, 03080
        • Clinical Trial Site
      • Suwon, South Korea, 16499
        • Clinical Trial Site
  • Spain
      • Madrid, Spain, 28007
        • Clinical Trial Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833401
        • Clinical Trial Site
      • Taichung, Taiwan, 40447
        • Clinical Trial Site
      • Tainan, Taiwan, 710
        • Clinical Trial Site
      • Taipei, Taiwan, 10002
        • Clinical Trial Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06560
        • Clinical Trial Site
      • Antalya, Turkey (Türkiye), 07070
        • Clinical Trial Site
      • Istanbul, Turkey (Türkiye), 34096
        • Clinical Trial Site
      • Izmir, Turkey (Türkiye), 35210
        • Clinical Trial Site
      • İzmit, Turkey (Türkiye), 41380
        • Clinical Trial Site
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Clinical Trial Site
      • Manchester, United Kingdom, M13 9PT
        • Clinical Trial Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Clinical Trial Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Clinical Trial Site
      • Scottsdale, Arizona, United States, 85259
        • Clinical Trial Site
      • Scottsdale, Arizona, United States, 85258
        • Clinical Trial Site
    • California
      • Irvine, California, United States, 92617
        • Clinical Trial Site
      • Los Angeles, California, United States, 90095
        • Clinical Trial Site
      • San Francisco, California, United States, 94115
        • Clinical Trial Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Clinical Trial Site
      • Denver, Colorado, United States, 80230
        • Clinical Trial Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Clinical Trial Site
      • Gainesville, Florida, United States, 32606
        • Clinical Trial Site
      • Jacksonville, Florida, United States, 32224
        • Clinical Trial Site
      • Plantation, Florida, United States, 33324
        • Clinical Trial Site
      • Tampa, Florida, United States, 33613
        • Clinical Trial Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Clinical Trial Site
      • Augusta, Georgia, United States, 30912
        • Clinical Trial Site
      • Marietta, Georgia, United States, 30060
        • Clinical Trial Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Clinical Trial Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Clinical Trial Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Clinical Trial Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Clinical Trial Site
      • New Orleans, Louisiana, United States, 70433
        • Clinical Trial Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Clinical Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Clinical Trial Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Clinical Trial Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical Trial Site
      • Rochester, Minnesota, United States, 55905
        • Clinical Trial Site
    • New York
      • Manhasset, New York, United States, 11030
        • Clinical Trial Site
      • New York, New York, United States, 10021
        • Clinical Trial Site
      • New York, New York, United States, 10017
        • Clinical Trial Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Clinical Trial Site
      • Cleveland, Ohio, United States, 44195
        • Clinical Trial Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Clinical Trial Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Clinical Trial Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Clinical Trial Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Clinical Trial Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Clinical Trial Site
    • Texas
      • Austin, Texas, United States, 78756
        • Clinical Trial Site
      • Houston, Texas, United States, 77030
        • Clinical Trial Site
      • Irving, Texas, United States, 75039
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
  • Adult subjects (18-75 years old)
  • Active muscle and skin disease at screening and baseline
  • Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant
  • Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2.

Exclusion Criteria:

  • Dermatomyositis with end-stage organ involvement
  • Dermatomyositis with irreversible muscle involvement

  • History of:

    • Any lymphoproliferative disorder
    • Active malignancy;
    • History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.)
    • Cancer-associated dermatomyositis
  • Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
  • Participants at a risk of thrombosis or cardiovascular disease
  • Participants with a high risk for herpes zoster reactivation
  • Participants with active or recent infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brepocitinib Dose Level 1 PO QD
Drug: Brepocitinib
Oral Brepocitinib
Experimental: Brepocitinib Dose Level 2 PO QD
Drug: Brepocitinib
Oral Brepocitinib
Placebo Comparator: Placebo PO QD
Drug: Placebo
Oral Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Improvement Score (TIS) at Week 52
Time Frame: 52 weeks
TIS is a composite endpoint based on improvement in the 6 Disease Activity Core Set Measure (CSM) scores and ranges from 0 to 100 (2016 American College of Rheumatology [ACR] Myositis Response Criteria/European League Against Rheumatism [EULAR]) where a higher score indicates more improvement
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in HAQ Disability Index score at Week 52
Time Frame: 52 weeks
Change from baseline in HAQ Disability Index score at Week 52. Health Assessment Questionnaire (HAQ) Disability Index: Score for function and disability from 0 [without any difficulty] to 3 [unable to do]. Higher score associated with worse outcome.
52 weeks
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
Time Frame: 52 weeks
CDASI Activity Score 0 to 100 with higher scores indicating a worse outcome.
52 weeks
Dermatomyositis Outcomes for Muscle and Skin (DMOMS) at Week 52
Time Frame: 52 weeks
DMOMS is a composite endpoint based on 4 component measures and ranges from 0 to 100 (Pandya, 2024) where a higher score indicates more improvement.
52 weeks
The proportion of participants achieving TIS ≥ 40 points (moderate improvement) at Week 52
Time Frame: 52 weeks
52 weeks
Time to achievement of consecutive (≥ 2 visits) TIS ≥ 40 points (moderate improvement) by Week 52
Time Frame: 52 weeks
52 weeks
The proportion of participants, regardless of baseline corticosteroid use, achieving TIS ≥ 40 points (moderate improvement) at Week 52 with 0 to ≤ 2.5 mg/day of oral prednisone (or equivalent) at both Week 48 and Week 52
Time Frame: 52 weeks
52 weeks
The proportion of participants achieving ≥ 40% improvement with a ≥ 4-point improvement from baseline in CDASI Activity Score at Week 52
Time Frame: 52 weeks
52 weeks
The proportion of participants achieving TIS ≥ 60 points (major improvement) at Week 52
Time Frame: 52 weeks
52 weeks
Change from baseline in CDASI Activity Score at Week 4
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Priovant Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Noriko Iikuni, MD, VP, Clinical Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PVT-2201-301
  • 2022-500367-12-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Priovant Therapeutics will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) from eligible studies upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Data requests will be reviewed and approved on the basis of scientific merit.

IPD Sharing Time Frame

The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.

IPD Sharing Access Criteria

Access will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA). Further details on Priovant Therapeutics' data sharing criteria and process for requesting access can be obtained by emailing info@priovanttx.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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