Deucravacitinib for Dermatomyositis

Overseen By Andrew L Mammen, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must be taking: Immunomodulatory drugs

Must not be taking: JAK inhibitors, Biologics

Disqualifiers: Other myositis, Lung disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether deucravacitinib, a drug approved for treating plaque psoriasis, can also benefit people with dermatomyositis (DM) or juvenile dermatomyositis (JDM). These conditions can cause muscle weakness, skin rashes, and fatigue, and not everyone responds to current treatments. The trial seeks participants who have not found success with other medications for DM or JDM. Participants will take deucravacitinib as a pill at home and visit the clinic regularly for check-ups. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to potential new therapies.

Will I have to stop taking my current medications?

You can continue taking corticosteroids and non-biologic immunosuppressive drugs during the study. However, you must be on at least one immunomodulatory medication when enrolling. Some medications, like rituximab and cyclophosphamide, have specific restrictions, so check with the study team for details.

Is there any evidence suggesting that deucravacitinib is likely to be safe for humans?

Research has shown that deucravacitinib is generally safe for conditions like plaque psoriasis. Studies have found it to be well-tolerated, with most people not experiencing serious side effects. The drug uniquely targets a specific part of the immune system, reducing the risk of unwanted effects.

Although fewer studies exist on its use for dermatomyositis, early results are promising. Some patients with hard-to-treat forms of this disease have shown improvements without major safety issues. Ongoing research aims to confirm these findings, but current data is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dermatomyositis?

Deucravacitinib is unique because it targets the TYK2 enzyme, a different approach than most current treatments for dermatomyositis, which often involve corticosteroids and immunosuppressants. This new mechanism of action could potentially offer a more targeted way to control the immune response, leading to fewer side effects. Researchers are excited about Deucravacitinib because it represents a novel way to possibly improve symptoms for patients who may not respond well to existing therapies.

What evidence suggests that deucravacitinib might be an effective treatment for dermatomyositis?

Research has shown that deucravacitinib, a medication approved for treating plaque psoriasis, may also benefit those with dermatomyositis (DM) and juvenile dermatomyositis (JDM). One study found that patients taking 6 mg of deucravacitinib daily experienced significant improvements in skin and pain relief within 10 weeks, with continued benefits after 6 months. Another report indicated that adding deucravacitinib to other treatments reduced burning sensations in the skin. These findings suggest that deucravacitinib might help manage symptoms of DM and JDM. Participants in this trial will take a 6 mg pill of deucravacitinib twice daily over 24 weeks, with an optional extension period. ^{2 6 7 8 9}

Who Is on the Research Team?

Andrew L Mammen, M.D.

Principal Investigator

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

Are You a Good Fit for This Trial?

Adults aged 18 and older with dermatomyositis (DM) or juvenile dermatomyositis (JDM), which are conditions that weaken the immune system and affect muscles, skin, joints, and lungs. Participants must be able to attend 9 clinic visits over 28 weeks for physical exams, heart function tests, questionnaires about daily life activities, and blood/urine tests.

Inclusion Criteria

I will take a pregnancy test at every clinic visit.

I am 18 years old or older.

Provision of signed and dated informed consent form

Exclusion Criteria

I have received IV methylprednisolone in the last 8 weeks.

Use of other investigational drugs at the time of enrollment

I have not used cyclophosphamide in the last 12 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive deucravacitinib, a 6mg pill taken twice per day, for 24 weeks

24 weeks

6 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Extension

Participants may extend their treatment with deucravacitinib if the drug is helping them

Long-term

Visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Deucravacitinib

Trial Overview The trial is testing deucravacitinib—a pill taken orally twice a day—to see if it can help people with DM or JDM. The study involves taking the medication at home with regular clinic visits every four weeks for monitoring over a period of six months.

How Is the Trial Designed?

Group I: Drug (Deucravacitinb) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

508

Recruited

1,090,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07012057

NCT07012057 | Study of Deucravacitinib for Refractory ... To obtain preliminary data regarding the efficacy of deucravacitinib to improve skin disease activity in adult patients with active, treatment-refractory JDM/DM ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12503779/

Successful Treatment of Refractory Dermatomyositis with ... Deucravacitinib 6 mg daily was initiated, leading to near-complete resolution of cutaneous lesions and complete resolution of pain within 10 weeks. At 6 months, ...

3. jaadcasereports.org jaadcasereports.org/article/S2352-5126(25)00132-8/fulltext

Successful treatment of recalcitrant amyopathic ... Deucravacitinib 6 mg daily was then added to the hydroxychloroquine, IVIG, and topical regimen. The patient noticed improvement with the burning ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10105327/

Use of JAK Inhibitors in Dermatomyositis: A Systematic ... Patients continued to experience improvement in CDASI scores in studies with long-term follow-up of JAK inhibitor treatment (20–96 weeks) (21-23). Table 1.

5. news.bms.com news.bms.com/news/details/2025/New-Five-Year-Sotyktu-deucravacitinib-Data-Show-Consistent-Safety-and-Durable-Response-Rates-in-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

New Five-Year Sotyktu (deucravacitinib) Data Show ... Clinical efficacy outcomes were sustained in patients who were continuously treated with Sotyktu for PASI 75 (72.1%, Year 1; 67.3%, Year 5) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12240123/

Successful treatment of recalcitrant amyopathic ... ... safety data of deucravacitinib use for plaque psoriasis. This safety profile is critical when being used to treat DM given its high association with malignancy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352512625005338

Novel use of Deucravacitinib for treatment of recalcitrant ... Novel use of Deucravacitinib for treatment of recalcitrant TIF1-Gamma Dermatomyositis ... data are needed in larger patient 100 populations ...

8. healio.com healio.com/news/rheumatology/20240815/pristine-safety-profile-sets-tyk2i-apart-from-jak-baggage-in-psoriatic-disease-lupus

'Pristine' safety profile sets TYK2i apart from JAK 'baggage ... Results at week 16 showed that 53% of patients in the deucravacitinib arm reached the primary endpoint of at least a 75% reduction from baseline ...

9. karger.com karger.com/cde/article/doi/10.1159/000548207/933759/Successful-Treatment-of-Refractory-Dermatomyositis

Successful Treatment of Refractory Dermatomyositis with ... The efficacy of deucravacitinib in refractory DM may stem from its high selectivity for TYK2, as it binds to a unique regulatory region rather ...