CClinicalTrials.gg
Sign In
Active, not recruitingNCT06433999Updated Nov 25, 2024

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.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-25.

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

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

Browse trials for

Keywords

  • skin-predominant dermatomyositis
  • dermatomyositis
03

Who can participate

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

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 body mass index (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 malignancy;
  • 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
04

Study design

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

Study arms

  • Experimental
    Brepocitinib

    Drug: Brepocitinib

Interventions

  • DrugBrepocitinib

    Oral Brepocitinib PO QD

05

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

06

Study locations

1 site
  • Clinical Trial Site
    Scottsdale, Arizona 85259, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Nov 25, 2024

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 active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dermatomyositis→

Other studies from this sponsor

Priovant Therapeutics, Inc.

Start the discussion