A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

Study Purpose

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies.

- Adult subjects (18-75 years old) - Active muscle and skin disease at screening and baseline.

- Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05437263
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Priovant Therapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Noriko Iikuni, MD
Principal Investigator Affiliation	VP, Clinical Development
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Belgium, Bulgaria, Canada, Chile, Czechia, Germany, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Spain, Taiwan, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Dermatomyositis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Brepocitinib Dose Level 1 PO QD

Experimental: Brepocitinib Dose Level 2 PO QD

Placebo Comparator: Placebo PO QD

Interventions

Drug: - Brepocitinib

Oral Brepocitinib

Drug: - Placebo

Oral Placebo

Contact a Trial Team

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Clinical Trial Site, Phoenix, Arizona

Status

Recruiting

Address

Clinical Trial Site

Phoenix, Arizona, 85028

Site Contact

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