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Autoimmune & Inflammatory

Dermatomyositis (DM) Clinical Trials and Treatments

Also called DM, Polymyositis (when without skin involvement)

Dermatomyositis is a systemic autoimmune disease characterized by inflammation of skin and skeletal muscles, with characteristic immune patterns including antibodies to myositis-associated antigens. The pathophysiology involves antibody-mediated complement activation leading to destruction of muscle and skin vasculature, with prominent CD4+ T cell infiltration.

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About Dermatomyositis

Dermatomyositis is a systemic autoimmune disease characterized by inflammation of skin and skeletal muscles, with characteristic immune patterns including antibodies to myositis-associated antigens. The pathophysiology involves antibody-mediated complement activation leading to destruction of muscle and skin vasculature, with prominent CD4+ T cell infiltration.

Muscle involvement typically affects proximal muscles (shoulders, hips) more than distal muscles, causing progressive weakness that can be profoundly disabling. Skin manifestations are characteristic: heliotrope rash (purple/violet discoloration of eyelids), Gottron papules (flat-topped papules over knuckles), and photosensitive rashes affecting shoulders, chest, and neckline. Calcinosis cutis (calcium deposits in skin) develops particularly in juvenile-onset disease.

Systemic manifestations include constitutional symptoms, malaise, and potential pulmonary involvement (interstitial lung disease in up to 30% of patients) and esophageal involvement causing dysphagia. Up to 30% of adult patients have underlying occult malignancy at diagnosis or develop malignancy subsequently. Myositis-specific antibodies (including anti-Jo-1, anti-Mi-2, anti-CADM-140) are present in about 60% of patients and have prognostic significance.

Common Symptoms of Dermatomyositis

Recognizing the signs of Dermatomyositis early can lead to faster diagnosis and better outcomes. Symptoms may vary in severity from person to person. If you or a loved one are experiencing any of the following, consider speaking with a specialist.

  • Progressive muscle weakness, typically in proximal muscles (shoulders, hips)
  • Distinctive heliotrope rash over eyelids (purple/violet discoloration)
  • Gottron papules on knuckles, elbows, and knees
  • Photosensitive rashes on chest and shoulders
  • Dysphagia (difficulty swallowing) from pharyngeal muscle involvement
  • Dyspnea (shortness of breath) from respiratory muscle or pulmonary involvement

Who Dermatomyositis Affects

Dermatomyositis has a bimodal age distribution with peaks in childhood (ages 5-10) and adults (ages 40-60). It affects females roughly twice as often as males. The disease occurs across all racial and ethnic groups.

Adult-onset disease is frequently associated with underlying malignancy (20-30%), particularly malignancies that were present or develop within 3 years of diagnosis. Anti-melanoma differentiation-associated gene 5 (MDA5) antibody-positive patients tend to have more severe interstitial lung disease.

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FDA-Approved Treatments for Dermatomyositis

There is currently 1 FDA-approved medication for Dermatomyositis. These therapies represent the current standard of care and may be used alongside or compared against investigational treatments in active clinical trials.

brepocitinib
Priovant Therapeutics
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

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Help Paying for Dermatomyositis Treatment

Charity funds and drugmaker programs for Dermatomyositis, checked at the source. Pick your insurance to see what fits.

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Charity funds
  • From a charity · The Assistance Fund
    Myositis fund
    Open

    Pays for: Copays, coinsurance, deductibles and other health-related expenses.

    The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.”
Status as each foundation showed it on September 28, 2026.
Drugmaker programs
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Side Effect Explorer

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Genetic Testing

Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.

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Trusted Dermatomyositis Resources

Reputable organizations and medical references for learning more about Dermatomyositis, including disease registries, foundation resources, and clinical guidelines.

Active Clinical Trials for Dermatomyositis

Use this Dermatomyositis clinical trial finder to see the 14 studies recruiting patients and 1 opening soon in the United States and worldwide, with eligibility criteria in plain English. These studies play a critical role in advancing care for autoimmune & inflammatory conditions and may offer access to treatments not yet widely available. Each trial below is sourced directly from ClinicalTrials.gov, with eligibility criteria translated into plain English to help patients and caregivers evaluate whether a study may be a fit.

TrialsSite mapPipeline timeline

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

55 active trials worldwide
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RECRUITINGPHASE2Recently updatedNCT07111065

FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)

Intervention: FISH OIL 500MG OMEGA-3 SOFT GEL MINIS, Placebo

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Dermatomyositis (DM) is a rare autoimmune disease that causes muscle weakness, skin rashes, and other symptoms. Researchers think both genetic and environmental factors play a role in this disease. They want to find out more about how diet and lifestyle choices affect people with DM/JDM.

Ages 18 Years – 60 Years1 location
Started Oct 2026Updated todayEst. Nov 2030 (~4y 1m)
RECRUITINGRecently updatedNCT01276470

Environmental Risk Factors for the Anti-synthetase Syndrome

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Background:

Ages 2 Years – 100 Years8 locations
Started Feb 2011Updated yesterdayCompletion date not listed
RECRUITINGRecently updatedNCT05738824

Natural History of Inflammatory Muscle Diseases

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

Objective:

To collect information and biospecimens (such as blood, muscle, and skin samples) that will be used to research causes and treatments of inflammatory muscle diseases.

Eligibility:

Ages 2 Years – 120 Years1 location
Started Jun 2023Updated 5 days agoEst. Feb 2032 (~5y 4m)
RECRUITINGPHASE3Recently updatedNCT06455449

A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Intervention: Anifrolumab (blinded), Placebo, Anifrolumab (unblinded, open label)

Sponsor: AstraZeneca

The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathi...

Ages 18 Years – 75 Years237 locations
Started Jun 2024Updated 5 days agoEst. Jan 2028 (~1y 3m)
RECRUITINGRecently updatedNCT00017914

Adult and Juvenile Myositis

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.

Ages 2 Years – 100 Years4 locations
Started Jun 1995Updated 5 days agoCompletion date not listed
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Trial Pipeline

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Patient Communities

Connect with other Dermatomyositis patients, caregivers, and advocacy groups across Facebook groups, Reddit communities, and YouTube channels. These patient communities offer peer support, shared experiences, caregiver resources, and real-time discussion about Dermatomyositis treatments, clinical trial participation, and day-to-day disease management.

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Related Autoimmune & Inflammatory Conditions

Other rare diseases in the autoimmune & inflammatory category. Patients with Dermatomyositis may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Companies Developing Dermatomyositis Treatments

12 pharmaceutical companies have Dermatomyositis in their rare disease portfolio

Frequently Asked Questions About Dermatomyositis