Brepocitinib for Dermatomyositis

LR
MC
Overseen ByMatt Cascino, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Priovant Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of brepocitinib for individuals with dermatomyositis, a condition that often causes skin problems and can make daily life challenging. The focus is on those whose skin issues haven't improved with other treatments and who have little to no muscle involvement. Individuals diagnosed with dermatomyositis and active skin symptoms might find this study suitable. Participants will take brepocitinib once daily for 12 weeks to assess its impact on their skin condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to potentially benefit from an emerging therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that brepocitinib was well-tolerated in past studies. In one large study with 225 participants, researchers compared brepocitinib to a placebo. The treatment achieved its main goals, demonstrating effectiveness without major safety issues.

Although this study is in an early phase, the absence of significant side effects so far is encouraging. Researchers continue to test the treatment for safety, but results suggest it is generally safe for people with conditions like dermatomyositis.12345

Why do researchers think this study treatment might be promising?

Brepocitinib is unique because it targets the Janus kinase (JAK) and tyrosine kinase 2 (TYK2) pathways, which play crucial roles in the inflammatory process seen in dermatomyositis. Most current treatments for dermatomyositis, such as corticosteroids and immunosuppressants, broadly suppress the immune system, which can lead to significant side effects. Brepocitinib's targeted approach offers the potential for more effective management of symptoms with fewer side effects. Researchers are excited about this treatment because it represents a more precise method of addressing the underlying causes of inflammation in dermatomyositis.

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

Studies have shown that brepocitinib, a medication that blocks certain proteins, effectively reduces inflammation in conditions like dermatomyositis. In previous research, brepocitinib achieved its main and secondary goals in patients with dermatomyositis, indicating strong potential for symptom relief. This trial will evaluate brepocitinib's effectiveness in reducing inflammation and improving skin symptoms by blocking specific proteins that cause inflammation. Early findings suggest that brepocitinib can significantly help patients with dermatomyositis by addressing the root causes of their skin issues.13467

Who Is on the Research Team?

MM

Mangold, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with dermatomyositis, specifically those who have skin symptoms but little to no muscle issues. Participants should weigh between 40 and 130 kg with a BMI under 40 kg/m2.

Inclusion Criteria

My weight is between 40kg and 130kg, and my BMI is less than 40.
I have visible skin symptoms of dermatomyositis.
I have been diagnosed with dermatomyositis.

Exclusion Criteria

I have a history of cancer.
My dermatomyositis has caused severe damage to my organs.
I am at risk for blood clots or heart disease.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 8 weeks

Treatment

Participants receive brepocitinib 30 mg orally once daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Brepocitinib
Trial Overview The study tests Brepocitinib's effectiveness and safety in treating skin-related symptoms of dermatomyositis over a period of 12 weeks. Patients will take the medication daily by mouth.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: BrepocitinibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Priovant Therapeutics, Inc.

Lead Sponsor

Trials
4
Recruited
570+

Citations

A Study to Investigate the Efficacy and Safety ...A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39008325/
Brepocitinib, a potent and selective TYK2/JAK1 inhibitorBrepocitinib is an oral, once-daily, novel, and specific TYK2/JAK1 inhibitor. Brepocitinib's potent inhibition of TYK2 and JAK1 reduces the signalling of pro- ...
Brepocitinib (PF-06700841) Clinical Study Report SyAnalysis of Efficacy Endpoints: In general, the data for all continuous efficacy endpoints were summarized by timepoint and treatment ...
Brepocitinib - Drug Targets, Indications, PatentsRoivant's TYK2/JAK1 dual inhibitor brepocitinib hit its primary and all nine key secondary endpoints in patients with dermatomyositis in the Phase III VALOR ...
Brepocitinib, a potent and selective TYK2/JAK1 inhibitorBrepocitinib, a potent and selective TYK2/JAK1 inhibitor: scientific and clinical rationale for dermatomyositis. By sjmartinez • July 16, 2024.
NCT05437263 | A Study to Investigate the Efficacy and ...A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (VALOR) ... Dermatomyositis Outcomes for Muscle and Skin (DMOMS) at ...
A 12-Week Open-Label Study to Investigate the Efficacy ...A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis · Phase.
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