Ruxolitinib Cream for Dermatomyositis

Overseen By Rothy Rim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The Cleveland Clinic

Must be taking: Systemic corticosteroids

Must not be taking: Janus kinase inhibitors

Disqualifiers: Active malignancy, Inflammatory myositis, 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: Unknown

Duration: 12 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called ruxolitinib to determine its safety and effectiveness in treating skin problems caused by dermatomyositis, a condition that leads to muscle weakness and skin rashes. The trial focuses on individuals whose skin issues have not improved with other treatments. Eligible participants include those with persistent skin symptoms from dermatomyositis despite standard treatments, and who have used but not recently applied common topical treatments like corticosteroids. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

No, you don't need to stop your current medications. You must have been on a stable medication regimen for at least 2 months and agree to keep it stable during the study.

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

Research has shown that ruxolitinib cream is generally well tolerated. In the year following its approval, safety data from everyday use revealed no major whole-body side effects. Studies also found it effective for conditions like atopic dermatitis (a type of skin inflammation) and vitiligo (loss of skin color in patches) over a year. This suggests that ruxolitinib cream might be safe for treating skin issues related to dermatomyositis. However, warnings exist about serious infections and other health risks in some cases. It is crucial to consult a healthcare provider about potential risks before considering joining a trial. ^{1 2 3 4 5}

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

Most treatments for dermatomyositis focus on suppressing the immune system using drugs like corticosteroids or immunosuppressants. But Ruxolitinib cream works differently, targeting the JAK-STAT signaling pathway that plays a role in inflammation and immune response. This unique mechanism has the potential to reduce inflammation directly in the skin with fewer systemic side effects. Additionally, being a topical cream, Ruxolitinib offers a more localized treatment option, which could mean fewer side effects compared to oral medications or injections commonly used for this condition. Researchers are excited about this approach because it could provide a more targeted and safer option for managing dermatomyositis symptoms.

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

Research has shown that ruxolitinib cream, which participants in this trial will receive, may help with skin problems related to dermatomyositis. In one case, a patient experienced significant skin improvement within a month of using the cream and discontinued other treatments. Ruxolitinib cream has also proven effective for other skin conditions like atopic dermatitis and hand eczema, with many patients achieving clear or nearly clear skin. This suggests that the cream could alleviate the skin symptoms of dermatomyositis by reducing inflammation and improving skin appearance. ^{6 7 8 9 10}

Who Is on the Research Team?

Anthony Fernandez, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for patients with dermatomyositis who have skin symptoms not relieved by standard treatments. They must have been on a stable medication regimen for at least 2 months, be willing to use contraception, and agree to monthly pregnancy tests if applicable. Participants need a confirmed diagnosis via skin biopsy and active cutaneous involvement.

Inclusion Criteria

I have a confirmed skin biopsy for dermatomyositis and current skin symptoms.

I am willing to take monthly pregnancy tests if I can become pregnant.

I agree to use birth control during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical ruxolitinib 1.5% cream for refractory cutaneous dermatomyositis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ruxolitinib

Trial Overview The study is testing Ruxolitinib Topical Cream's safety and effectiveness in treating the stubborn skin symptoms of dermatomyositis. The hypothesis suggests that this cream will help where other medications haven't.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

1.5 % Ruxolitinib cream

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10876464/

Efficacy of topical ruxolitinib for cutaneous dermatomyositis Within 1 month, she had significant improvement in skin disease (Fig 1, B) and self-discontinued topical tacrolimus and desonide. Additional quiescent cutaneous ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06857240

Study Details | NCT06857240 | Topical Ruxolitinib Cream ... In phase 2 and 3 trials in atopic dermatitis, topical ruxolitinib 1.5% cream resulted in significant efficacy in terms of improving both disease activity and ...

3. jaad.org jaad.org/article/S0190-9622(25)02717-3/pdf

Efficacy and safety of ruxolitinib cream for the treatment of ... In this first randomized controlled trial of ruxolitinib cream in chronic, nonatopic hand eczema, most (53.2%) patients achieved clear/almost ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950312425000028

Therapeutic efficacy and safety of topical ruxolitinib in mild- ... The results indicated that topical ruxolitinib is effective in significantly reducing atopic dermatitis symptoms, with particular emphasis on the 1.5 % ...

5. jddonline.com jddonline.com/wp-content/themes/jdd-salient-child/download.php?pii=S1545961625S49142X&download=1

Appraisal of Ruxolitinib 1.5% Cream as a First-Line Topical ... Here, we review the most up-to-date clinical trial and real-world efficacy data that position ruxolitinib 1.5% cream as a first-line AD ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06857240?term=AREA%5BConditionSearch%5D(dermatomyositis)&rank=7

Topical Ruxolitinib Cream for Refractory Cutaneous ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

7. jaadcasereports.org jaadcasereports.org/article/S2352-5126(23)00427-7/fulltext

Efficacy of topical ruxolitinib for cutaneous dermatomyositis 5. Topical ruxolitinib is Food and Drug Administration-approved for pediatric vitiligo and atopic dermatitis. 2. To our knowledge, this is the ...

8. healio.com healio.com/news/dermatology/20240430/safety-data-show-ruxolitinib-cream-well-tolerated-in-atopic-dermatitis-vitiligo-at-1-year

Safety data show ruxolitinib cream well tolerated in atopic ... Safety data show ruxolitinib cream well tolerated in atopic dermatitis, vitiligo at 1 year. April 30, 2024. 1 min read. ByGabrielle M. Grasso.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/215309s001lbl.pdf

FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY,. MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND. THROMBOSIS. See full prescribing information for ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10866801/

Real-World Use of Ruxolitinib Cream: Safety Analysis at 1 ... Postmarketing safety data from the year following approval suggest ruxolitinib cream is generally well tolerated, without significant systemic ...