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NCT05523167 · ClinicalTrials.gov registry record · Phase 2

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

A Phase 2 study of Dermatomyositis and Polymyositis, sponsored by argenx.

Active
Registry status
Phase 2
Development phase
265
Enrollment target
20
Study locations

NCT05523167 is a Phase 2 study of Dermatomyositis and Polymyositis that is active but no longer recruiting, run by argenx. The registered enrollment target is 265 participants, below the 471-participant average among 19 other Dermatomyositis trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT05523167, a Phase 2 study of Dermatomyositis and Polymyositis, is active but no longer recruiting, sponsored by argenx.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
265 participants
Enrollment target
20
Study locations

Study Summary

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome \[ASyS\]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

Conditions Studied

Dermatomyositis Polymyositis Myositis Immune-Mediated Necrotizing Myopathy Active Idiopathic Inflammatory Myopathy Antisynthetase Syndrome

Interventions

  • BIOLOGICAL EFG PH20 SC
  • OTHER PBO

Study Locations (20)

California

  • Attune Health Research, Inc - Beverly Hills
  • University of Southern California Norris Comprehensive Cancer Center - Los Angeles
  • Profound Research LLC - Oceanside - Oceanside
  • University of California, Irvine - Orange
  • Eisenhower Medical Center - Rancho Mirage
  • Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine - Redwood City
  • California Pacific Medical Center - Sutter Health - San Francisco
  • Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF) - San Francisco

Florida

  • UF Health Rheumatology - Gainesville
  • Mayo Clinic - Jacksonville
  • University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare) - Tampa

Arizona

  • Neuromuscular Research Center - Phoenix
  • HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology - Scottsdale

Georgia

  • Emory University Hospital, The Emory Clinic - Atlanta
  • Augusta University - Augusta

Colorado

  • Denver Arthritis Clinic - Denver

Connecticut

  • Yale Cancer Center-Yale University School Of Medicine - New Haven

District of Columbia

  • Georgetown University Hospital - Washington D.C.

Illinois

  • Northwestern Memorial Hospital - Chicago

Trial Details

FieldValue
Enrollment Target 265 participants
Start Date 2022-10-12
Est. Completion 2027-02-01
Phase Phase 2

Sponsor

argenx

49 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05523167

The ClinicalTrials.gov registry entry for NCT05523167 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 265 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 471-participant average among 19 other Dermatomyositis trials with a reported enrollment target (44% lower). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 2 interventions - of which EFG PH20 SC is the first listed.

NCT05523167 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT05523167 about?

NCT05523167 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.". This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of...

What is the current status of trial NCT05523167?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2022-10-12. Estimated completion is 2027-02-01.

What conditions does trial NCT05523167 study?

This clinical trial studies the following conditions: Dermatomyositis, Polymyositis, Myositis, Immune-Mediated Necrotizing Myopathy, Active Idiopathic Inflammatory Myopathy.

What interventions are being tested in trial NCT05523167?

The interventions under investigation include: EFG PH20 SC (BIOLOGICAL), PBO (OTHER).

Who is sponsoring clinical trial NCT05523167?

This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05523167 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.