Study of Deucravacitinib for Refractory Adults With Dermatomyositis/Juvenile Dermatomyositis

NCT07012057 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: 10002167002167-AR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Dermatomyositis (DM) and juvenile dermatomyositis (JDM) are diseases that weaken the immune system. DM and JDM can affect the muscles, skin, joints, and lungs and cause skin rashes and muscle inflammation. Symptoms include weakness, pain, fatigue, and rash. Not everyone responds to current treatments. The FDA has approved a drug called deucravacitinib to treat people with plaque psoriasis. Researchers want to find out if this drug can help people with DM or JDM, too. Objective: To test deucravacitinib in people with DM or JDM. Eligibility: People aged 18 years and older with DM or JDM. Design: Participants will have 9 clinic visits over 28 weeks. Participants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will complete a short questionnaire about their daily life, pain level, and ability to walk, eat, and do other activities. Deucravacitinib is a pill taken by mouth twice per day at home. Participants will come to the clinic once every 4 weeks for 24 weeks while they are taking the drug. They will have a final visit 4 weeks after their last dose of the study drug. Blood and urine tests will be repeated during these visits. Each visit may take up to 6 hours. If the drug is helping them, participants may extend their treatment beyond the first 24 weeks. Then they will visit the clinic every 3 months.

Conditions

Myositis; Dermatomyositis

Keywords

Dermatomyositis; Myositis; Juvenile Dermatomyositis; Deucravacitinib; Janus Kinase Inhibitor

Outcome Measures

Primary Outcomes (1)

• To obtain preliminary data regarding the efficacy of a selective TYK2 inhibitor, deucravacitinib, in adult patients with active, treatment-refractory DM/JDM

  The number of DM/JDM patients at least a minimal Clinical response using the total improvement score as defined in 2016 ACR/EULAR Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis and Juvenile Dermatomyositis

  At 24 weeks

Secondary Outcomes (2)

• To obtain preliminary data regarding the efficacy of deucravacitinib to improve skin disease activity in adult patients with active, treatment-refractory DM/JDM, as defined by the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

  At 24 weeks

• To obtain preliminary data regarding the frequency and incidence of adverse events in treatment-refractory dermatomyositis patients treated with deucravacitinib.

  Over 28 weeks

Study Arms (1)

Drug (Deucravacitinb)

EXPERIMENTAL

Participants will receive a 6mg pill taken 2 times per day over 24 weeks and an optional extension period

Drug: Deucravacitinb

Interventions

Deucravacitinb DRUG

Participants will receive a 6mg pill taken 2 times per day over 24 weeks and an optional extension period

Drug (Deucravacitinb)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Male or female, 18 years of age or older, of any race or ethnicity.
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Ability to take oral medication and willingness to adhere to the deucravacitinib regimen.
• Definite or probable dermatomyositis or juvenile onset dermatomyositis by ACR/EULAR criteria
• Refractory myositis as defined by intolerance or inadequate response to at least a 12-week trial of corticosteroids and at least one other first line immunomodulatory agent. The definition of intolerance is side effect(s) that require discontinuation of the medication or an underlying condition that precludes the further use of the medication. Adequate treatment with corticosteroids or immunomodulatory drugs is defined as at least the lowest of the following doses:
• Corticosteroids: 20mg/day for at least 4 weeks with total duration at any dose for at least 12 weeks. If there is intolerance, trial must be for at least 2 weeks.
• Methotrexate: 15 mg/week for 12 weeks
• IVIg: 1 g/kg/month or 60 g/month for 3 months
• Azathioprine: 150 mg/d for at least 12 weeks
• Mycophenolate mofetil: 1000 mg twice daily for at least 12 weeks
• Cyclophosphamide: 500 mg/month intravenously for at least 3 months
• Tacrolimus: 5 mg/d for at least 12 weeks
• Cyclosporine: 2.4 mg/kg/d for at least 12 weeks

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Prior use of a JAK inhibitor.
• Use of other investigational drugs at the time of enrollment.
• Rituximab use within 6 months.
• If rituximab given within 12 months, absence of detectable CD20 cells.
• Concurrent use of any biologic agent other than IVIG.
• Cyclophosphamide use within 12 months.
• Prednisone dose greater than 20 mg/day.
• Change in dose of prednisone within 4 weeks prior to the baseline timepoint.
• Prednisone at a dose of 80 mg or more within 4 weeks prior to baseline timepoint.
• Intravenous methylprednisolone within 8 weeks prior to baseline timepoint.
• Change in dose of methotrexate, azathioprine, mycophenolate, leflunomide, IVIG, cyclosporine, hydroxychloroquine, or tacrolimus within 12 weeks prior to the baseline timepoint.
• History of hypersensitivity to the study drug or drugs of similar chemical classes.
• Late-stage DM patients whose muscle weakness, according to the Investigator, could be attributable to muscle damage rather than myositis disease activity.
• Patients with history of positive anti-Jo1 or other antisynthetase autoantibodies.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Myositis; Dermatomyositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Polymyositis; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Andrew L Mammen, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 10, 2025
• Study Start: November 21, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)