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NCT06433999 Clinical Trial

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

Dermatomyositis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06433999
Other study ID # PVT-2201-202
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 2024
Est. completion date January 2025

Study information
Verified date June 2024
Source Priovant Therapeutics, Inc.
Contact Lindsey Rios, BS
Phone (860) 307-5311
Email lindsey.rios@priovanttx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 5
Est. completion date January 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Brepocitinib
Oral Brepocitinib PO QD

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Priovant Therapeutics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint is the change in CDASI-A score from baseline through Week 12 12 weeks
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