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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: Active Phase 2 study of Dermatomyositis and Polymyositis, sponsored by argenx.
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. According to ClinicalTrials.gov, the official US trial registry.
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/.
Primary Outcome
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2022-10-12 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 2 |
What the registry record for NCT05523167 still lists
NCT05523167 is an interventional study that assigns participants to a tested intervention. The registered 265 participants enrollment target is mid-sized for trials with a published cap, below the 471-participant average among 19 other Dermatomyositis trials with a reported enrollment target (44% lower).
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 names 20 study sites across 9 states, led by 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, Anti-Synthetase Syndrome, Immune-Mediated Necrotizing 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.
Learn More About Clinical Trials
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Where NCT05523167's enrollment target sits among peer trials
265 7th of 19 higher than 13 of 19 other Dermatomyositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatomyositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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