Zero ad trackers.We never sell your data.Healthcare professional?Clinician Resources
Home/Rare Diseases/Dermatomyositis

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.

In plain words, dermatomyositis is a rare immune system disease that attacks the muscles and skin, along with their small blood vessels. Most people get a skin rash, often over the knuckles and other joints, and muscle weakness is also common.

Get an email when new Dermatomyositis trials open or the FDA decides. Get alerts

Dermatomyositis

Where treatments stand, from ClinicalTrials.gov and FDA labels

FDA review0

No decision pending. FDA calendar

FDA-approved medicines4

Lisraya · Acthar Gel · Corticosteroids · Immune globulin

Dermatomyositis has 4 FDA-approved medicines, 42 open or active clinical trials, and no pending FDA decision.

Labels checked October 21, 2026. Corticosteroids and immune globulins count once each.Download the data

Latest for Dermatomyositis

See all trialsThe week in rare disease

Each date is the day a change was posted. Open an item to see where things stand now.

More about Dermatomyositis

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.

Keep reading about Dermatomyositis

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.

What are the symptoms of Dermatomyositis?

These are common symptoms of Dermatomyositis, and how strong they are varies from person to person.

  • 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 gets Dermatomyositis?

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.

Next steps: find trials you might fitsee approved treatmentsget help payingget alerts

Which medicines are FDA-approved for Dermatomyositis?

There are currently 4 FDA-approved medications for Dermatomyositis.

Just prescribed one of these?Your first 90 days, step by stepWhat happens before the first fill, the tests and refills to expect, and help paying, with a one-page handout to print.
brepocitinib
Your first 90 days
Priovant Therapeutics
Search
Acthar Gel
repository corticotropin injection
Corticosteroids
prednisone, prednisolone, methylprednisolone, dexamethasone, hydrocortisone, betamethasone, triamcinolone
Immune globulin
immune globulin (human)

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

Which new Dermatomyositis medicines are in trials?

Investigational medicines Trial Friend tracks for Dermatomyositis, with trial results, safety findings and where each one stands.

How to get help paying for Dermatomyositis treatment

Charity funds and drugmaker programs for Dermatomyositis, checked at the source.

Which insurance do you have? Pick one to see what fits. Tap it again to clear.
Your insurance
Charity funds
  • From a charity · The Assistance Fund
    Myositis fund
    Open

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

  • From a charity · TotalAssist (formerly PAN Foundation)
    Dermatomyositis fund
    Open

    Pays for: Out-of-pocket costs for approved medications, up to $9,000 per year. Requires health insurance (any kind).

Status as each foundation showed it on October 26, 2026.
Drugmaker programs
Open a medicine for who qualifies, by insurance type.

Every program and fund for Dermatomyositis, by insurance →

Side effects people have reported to the FDA

Side effects people have reported to the FDA

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.

Loading side effect data...

Diagnosis and genetic testing

Genetic testing for Dermatomyositis

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

Finding labs...

Trusted Dermatomyositis resources

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

Study you can followBoehringer Ingelheim's phase 3 nerandomilast study: get one email when it opens near you, and check its main requirements privately before talking with your doctor. →

Active clinical trials for Dermatomyositis

Use this Dermatomyositis clinical trial finder to see the 18 studies recruiting patients and 2 not yet recruiting in the United States and worldwide, with eligibility criteria in plain English. Of these, 14 test a treatment and 6 are observational studies or registries; each card says which. Every trial comes from ClinicalTrials.gov.

Jump to the trial list, the site map or the pipeline 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.

42 active trials worldwide
Filter:
Sort:
RecruitingTreatment trialPhase 2Recently 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 to 62 Years1 location
Expected to start Nov 2026Updated todayEst. Nov 2030 (~3y 11m)
RecruitingTreatment trialPhase 2/3Recently updatedNCT06154252

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Intervention: CABA-201 following preconditioning with fludarabine and cyclophosphamide

Sponsor: Cabaletta Bio

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Ages 6 Years to 75 Years
Started Dec 2023Updated todayEst. Jul 2028 (~1y 8m)
RecruitingTreatment trialPhase 1Recently updatedNCT03816345

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

Intervention: Biospecimen Collection, Cabozantinib, Fluoropyrimidine, Ipilimumab, Nivolumab, Platinum Compound, Platinum Doublet

Sponsor: National Cancer Institute (NCI)

This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer th...

Ages 18 Years+
Started Jul 2019Updated yesterdayEst. Mar 2028 (~1y 4m)
RecruitingTreatment trialPhase 2Recently updatedNCT06857240

Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis

Intervention: Ruxolitinib Topical Cream

Sponsor: The Cleveland Clinic

This study will assess the safety and efficacy of topical ruxolitinib for treating the refractory cutaneous manifestations in patients with dermatomyositis. The investigators' hypothesis is that topical ruxolitinib will be both safe and effective for such patients.

Ages 18 Years to 89 Years1 location
Started Jun 2025Updated 2 weeks agoEst. Dec 2030 (~4y 1m)
RecruitingObservational study, no treatment givenRecently updatedNCT01276470

Environmental Risk Factors for the Anti-synthetase Syndrome

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Background:

Ages 2 Years to 100 Years2 locations
Started Feb 2011Updated 4 weeks agoCompletion date not listed
Find Dermatomyositis trials near you, ranked by distance →
Active trial locations90 cities in the US
A study site. Select it to see its trials and get directions. Several sites close together. Select the number to zoom in.
+82 more

Trial Pipeline

Jan 2021 to Nov 2031
2021
2023
2025
2027
2029
2031
now
Phase 1
Phase 2
Phase 3
Observational
Observational
RecruitingNot yet recruitingDelayed startTodayHover a bar for trial details

Read more about Dermatomyositis trials

Need help understanding these trials?
Answers with sources, in plain English
Start withor ask
Run a Dermatomyositis foundation or patient group?
You can put this live trial list on your own website. It updates itself, and it's free.
Get the embed code →

Data from ClinicalTrials.gov, U.S. National Library of Medicine.
Always talk to your doctor before considering a clinical trial.

Dermatomyositis patient communities

Facebook groups, Reddit communities and YouTube channels where Dermatomyositis patients, caregivers and advocacy groups talk.

Companies developing Dermatomyositis treatments

Drugmakers that list Dermatomyositis in their rare disease portfolio, with makers of its treatments first.

Questions people ask about Dermatomyositis