ClinicalTrials.gg
CompletedNCT06433999Updated May 20, 2025

A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis

A Phase 2 interventional study of Brepocitinib in Dermatomyositis and Dermatomyositis, Adult Type, sponsored by Priovant Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Priovant Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2025, 1 year 8 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.

02

Conditions studied

  • Dermatomyositis
  • Dermatomyositis, Adult Type

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Keywords

  • skin-predominant dermatomyositis
  • dermatomyositis
03

In context

Dermatomyositis

184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.

This study's enrollment of 5 is below the median of 35 across 130 interventional studies indexed under Dermatomyositis.

Browse Dermatomyositis studies →

Lead sponsor

Priovant Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
  • Active cutaneous manifestations of dermatomyositis
  • Adult subjects (18-75 years old)
  • Weight > 40 kg to \< 130 kg, and with a (BMI) \< 40 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Dermatomyositis with end-stage organ involvement
  • Dermatomyositis with irreversible muscle involvement

History of:

  • Any lymphoproliferative disorder
  • Active ;
  • History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associated dermatomyositis
  • Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
  • Participants at a risk of thrombosis or cardiovascular disease
  • Participants with a high risk for herpes zoster reactivation
  • Participants with active or recent infections
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Brepocitinib

    Drug: Brepocitinib

Interventions

06

What researchers measure

Primary outcomes

  1. The primary endpoint is the change in CDASI-A score from baseline through Week 12

    Time frame: 12 weeks

07

Study locations

1 site
  • Clinical Trial Site
    Scottsdale, Arizona 85259, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06433999
Lead sponsor
Priovant Therapeutics, Inc.
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Aug 28, 2024
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
May 20, 2025

Study contacts

Mangold, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: PF-06700841

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