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
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Dermatomyositis
• Dermatomyositis, Adult Type

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