A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
VALOR
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
2 other identifiers
interventional
241
22 countries
109
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2022
Typical duration for phase_3
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
October 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedSeptember 29, 2025
September 1, 2025
2.7 years
June 24, 2022
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Improvement Score (TIS) at Week 52
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 Outcomes (9)
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
52 weeks
Dermatomyositis Outcomes for Muscle and Skin (DMOMS) at Week 52
52 weeks
The proportion of participants achieving TIS ≥ 40 points (moderate improvement) at Week 52
52 weeks
Time to achievement of consecutive (≥ 2 visits) TIS ≥ 40 points (moderate improvement) by Week 52
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
52 weeks
- +4 more secondary outcomes
Study Arms (3)
Brepocitinib Dose Level 1 PO QD
EXPERIMENTALBrepocitinib Dose Level 2 PO QD
EXPERIMENTALPlacebo PO QD
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (109)
Clinical Trial Site
Phoenix, Arizona, 85028, United States
Clinical Trial Site
Scottsdale, Arizona, 85258, United States
Clinical Trial Site
Scottsdale, Arizona, 85259, United States
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Irvine, California, 92617, United States
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Los Angeles, California, 90095, United States
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San Francisco, California, 94115, United States
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Aurora, Colorado, 80045, United States
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Denver, Colorado, 80230, United States
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Boynton Beach, Florida, 33472, United States
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Gainesville, Florida, 32606, United States
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Jacksonville, Florida, 32224, United States
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Plantation, Florida, 33324, United States
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Tampa, Florida, 33613, United States
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Atlanta, Georgia, 30322, United States
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Augusta, Georgia, 30912, United States
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Marietta, Georgia, 30060, United States
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Chicago, Illinois, 60637, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66160, United States
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New Orleans, Louisiana, 70112, United States
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New Orleans, Louisiana, 70433, United States
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Baltimore, Maryland, 21224, United States
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Boston, Massachusetts, 02115, United States
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Ann Arbor, Michigan, 48103, United States
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Minneapolis, Minnesota, 55455, United States
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Rochester, Minnesota, 55905, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10017, United States
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New York, New York, 10021, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44195, United States
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Oklahoma City, Oklahoma, 73116, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Jackson, Tennessee, 38305, United States
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Austin, Texas, 78756, United States
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Houston, Texas, 77030, United States
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Irving, Texas, 75039, United States
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Quilmes, Buenos Aires, B1878DVB, Argentina
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Caba, Buenos Aires F.D., 1425, Argentina
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Mendoza, 5519, Argentina
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Leuven, 3000, Belgium
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4001, Bulgaria
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Plovdiv, 4004, Bulgaria
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Sofia, 1407, Bulgaria
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Vancouver, British Colombia, V5Y1K2, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Concepción, Región del Biobío, 4070280, Chile
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Recoleta, 8420383, Chile
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Santiago, 7640881, Chile
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Santiago, 8331150, Chile
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Temuco, 4800827, Chile
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Prague, 128 00, Czechia
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Mainz, Rhineland-Palatinate, 55131, Germany
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Berlin, 10117, Germany
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Berlin, 15562, Germany
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Dresden, 01307, Germany
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Essen, 45147, Germany
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Freiburg im Breisgau, 79106, Germany
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Debrecen, 4032, Hungary
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Pécs, 7632, Hungary
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Szeged, 6720, Hungary
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Ashkelon, 7830604, Israel
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Haifa, 3109601, Israel
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Poria – Neve Oved, 1528001, Israel
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Tel Aviv, 6423906, Israel
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Tel Litwinsky, 52621, Israel
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Bari, 70126, Italy
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Pavia, 27100, Italy
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Roma, 00168, Italy
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Torino, 10126, Italy
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Monterrey, Nuevo León, 64718, Mexico
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Mérida, Yucatán, 97070, Mexico
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Guadalajara, 44690, Mexico
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Mexico City, 06700, Mexico
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San Luis Potosí City, 78290, Mexico
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Nijmegen, Gelderland, 6500 HB, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Bialystok, Podlaskie Voivodeship, 15-704, Poland
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Krakow, 30-363, Poland
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Lublin, 20-400, Poland
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Lublin, 20-607, Poland
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Nowa Sól, 67-100, Poland
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Poznan, 61-293, Poland
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Warsaw, 02-637, Poland
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Vila Nova de Gaia, Porto District, 4434-502, Portugal
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Guimarães, 4835-044, Portugal
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Lisbon, 1649-028, Portugal
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Porto, 4099-001, Portugal
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Bucharest, 011172, Romania
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Cluj-Napoca, 400000, Romania
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Belgrade, 11000, Serbia
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Seoul, 03080, South Korea
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Suwon, 16499, South Korea
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Madrid, 28007, Spain
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Kaohsiung City, 833401, Taiwan
Clinical Trial Site
Taichung, 40447, Taiwan
Clinical Trial Site
Tainan, 710, Taiwan
Clinical Trial Site
Taipei, 10002, Taiwan
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Ankara, 06560, Turkey (Türkiye)
Clinical Trial Site
Antalya, 07070, Turkey (Türkiye)
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Istanbul, 34096, Turkey (Türkiye)
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Izmir, 35210, Turkey (Türkiye)
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İzmit, 41380, Turkey (Türkiye)
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Bath, BA1 3NG, United Kingdom
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Manchester, M13 9PT, United Kingdom
Clinical Trial Site
Wolverhampton, WV10 0QP, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2022
First Posted
June 29, 2022
Study Start
October 31, 2022
Primary Completion
July 17, 2025
Study Completion (Estimated)
July 1, 2026
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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.