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ACTIVE NOT RECRUITING Phase 3

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

NCT05437263 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Brepocitinib

Study Locations (20)

Florida

  • Clinical Trial Site — Boynton Beach
  • Clinical Trial Site — Gainesville
  • Clinical Trial Site — Jacksonville
  • Clinical Trial Site — Plantation
  • Clinical Trial Site — Tampa

Arizona

  • Clinical Trial Site — Phoenix
  • Clinical Trial Site — Scottsdale
  • Clinical Trial Site — Scottsdale

California

  • Clinical Trial Site — Irvine
  • Clinical Trial Site — Los Angeles
  • Clinical Trial Site — San Francisco

Georgia

  • Clinical Trial Site — Atlanta
  • Clinical Trial Site — Augusta
  • Clinical Trial Site — Marietta

Colorado

  • Clinical Trial Site — Aurora
  • Clinical Trial Site — Denver

Illinois

  • Clinical Trial Site — Chicago

Iowa

  • Clinical Trial Site — Iowa City

Kansas

  • Clinical Trial Site — Kansas City

Trial Details

FieldValue
Enrollment Target 241 participants
Start Date 2022-10-31
Est. Completion 2026-07
Phase Phase 3

Sponsor

Priovant Therapeutics

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05437263

The ClinicalTrials.gov registry entry for NCT05437263 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Priovant Therapeutics, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Dermatomyositis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05437263 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05437263 about?

NCT05437263 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis". 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 m...

What is the current status of trial NCT05437263?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2022-10-31. Estimated completion is 2026-07.

What conditions does trial NCT05437263 study?

This clinical trial studies the following conditions: Dermatomyositis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05437263?

The interventions under investigation include: Placebo (DRUG), Brepocitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05437263?

This trial is sponsored by Priovant Therapeutics, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05437263 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial