Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05437263 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Dermatomyositis, sponsored by Priovant Therapeutics.

Active
Registry status
Phase 3
Development phase
241
Enrollment target
20
Study locations

NCT05437263 is a Phase 3 study of Dermatomyositis that is active but no longer recruiting, run by Priovant Therapeutics. The registered enrollment target is 241 participants, below the 472-participant average among 19 other Dermatomyositis trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 9 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05437263, a Phase 3 study of Dermatomyositis, is active but no longer recruiting, sponsored by Priovant Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
241 participants
Enrollment target
20
Study locations

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

Dermatomyositis

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

6 total trials

Interested in This Trial?

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, categorized as Phase 3. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 472-participant average among 19 other Dermatomyositis trials with a reported enrollment target (49% lower). The listed sponsor is Priovant Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.

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.

NCT05437263 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, Arizona, California.

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.

What interventions are being tested in trial NCT05437263?

The interventions under investigation include: Placebo (DRUG), Brepocitinib (DRUG).

Who is sponsoring clinical trial NCT05437263?

This trial is sponsored by Priovant Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Dermatomyositis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Dermatomyositis

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.