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Promising psoriasis drug study for rare muscle disease pulled before start

NCT ID NCT07012057

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to test deucravacitinib, a drug already approved for psoriasis, in adults with hard-to-treat dermatomyositis (DM) or juvenile dermatomyositis (JDM). Participants would have taken a pill twice daily for 24 weeks, with clinic visits every 4 weeks. However, the study was withdrawn before enrolling anyone, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Nov 2025

Finished

Nov 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: 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 * Rituximab: 750mg for at least 2 infusions * Adalimumab: 40mg SQ every other week for at least 12 weeks * Infliximab: 1000mg every 4 weeks for at least 12 weeks * Abatacept: * IV 10mg/kg or 750mg every 4 weeks for 12 weeks * SQ 125mg weekly for at least 12 weeks * Tocilizumab: ---IV 800mg every 4 weeks for at least 12 weeks * SQ 162mg/dose every 2 weeks for at least 12 weeks Note: Doses/Timelines may be shorter will still qualify if there is documented intolerance. Other medications can be accepted on a case-by-case basis in consultation with the safety committee. * Concurrent medications: Corticosteroids and non-biologic immunosuppressive/ immunomodulatory drugs can be continued on study. IVIg can also be continued on study. Study participants must be on at least one immunomodulatory medication when enrolling on this study as standard therapy. * Active disease based on Manual Muscle Testing (MMT-8) of \<136/150 and any 1 of the following core disease activity measures: 1. Physician global activity of \>= 3.0/10.0 2. Patient global activity of \>= 3.0/10.0 3. Extramuscular global activity of \>= 3.0/10.0 4. Health Assessment Questionnaire (HAQ) score of \>= 0.75 * Women of child-bearing potential must be willing to undergo pregnancy testing at every on-site visit for the duration of the study. * For females of reproductive potential: use of highly effective contraception for at least one month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of deucravacitinib administration. * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. * Must be English-speaking EXCLUSION CRITERIA: 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 other types of myositis or myopathies: polymyositis, paraneoplastic myositis, inclusion body myositis, metabolic or drug induced myopathy, dystrophies. * Patients with history of positive anti-Jo1 or other antisynthetase autoantibodies. * Patients with advanced clinically symptomatic interstitial lung disease. * Pregnant or breast-feeding patients. * History of or active rapidly-progressive interstitial lung disease. * History of bowel rupture or inflammatory bowel diseases. * Evidence of latent or active tuberculosis or mycobacterial infections. * Recent infection requiring antibiotics in the past 4 weeks before entry of study. * History of any malignancy of any organ system (other than localized basal cell carcinoma of the skin or cutaneous squamous cell carcinoma in situ), treated or untreated, within the past 3 years, regardless of whether there is evidence of local recurrence or metastases. * Evidence of any other acute or chronic infectious diseases, including hepatitis, HIV, TB, etc. * Have had symptomatic herpes zoster infection within 12 weeks prior to entry or during the screening period or recurrent herpes simplex infection * Have a history of disseminated/complicated herpes zoster (for example, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia) * Have received any live or live attenuated vaccines (including varicella or measles) within 2 months prior to study enrollment. * Current or recent history of uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease. * Any other condition or criterion that, in the judgment of the Investigator, would either pose an unacceptable risk to the participant or interfere with the interpretation of the study results. * Adults who lack capacity to consent. * Have a history of chronic alcohol abuse or intravenous drug abuse within the 2 years prior to entry. * History of previous blood clot such as deep vein thrombosis, pulmonary embolus, or other significant increased risk for blood clots * Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures. * Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * Have joint disease or other musculoskeletal condition including contractures or calcinosis, which precludes the ability to quantitate muscle strength. * Hospitalization within the past 30 days, other than scheduled infusion or procedure. * Total WBC count \<2500 cells/microliter; Absolute neutrophil count \<= 1000/mm3; platelets \<= 100,000/microliter; hemoglobin \<= 10gm

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.