A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
Public ClinicalTrials.gov record NCT05523167. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05523167
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 265 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 12, 2022 (Actual)
- Primary completion
- Jul 2, 2026 (Actual)
- Completion
- Jul 2, 2026 (Actual)
- Last update posted
- Sep 21, 2026
2022 – 2026
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neuromuscular Research Center | Phoenix | Arizona | 85028 | — |
| HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology | Scottsdale | Arizona | 85251 | — |
| Attune Health Research, Inc | Beverly Hills | California | 90039 | — |
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Profound Research LLC - Oceanside | Oceanside | California | 92056 | — |
| University of California, Irvine | Orange | California | 92868 | — |
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | — |
| Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine | Redwood City | California | 94063-3132 | — |
| California Pacific Medical Center - Sutter Health | San Francisco | California | 94109 | — |
| Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF) | San Francisco | California | 94143-2202 | — |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | — |
| Yale Cancer Center-Yale University School Of Medicine | New Haven | Connecticut | 06520 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| UF Health Rheumatology | Gainesville | Florida | 32610-3008 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare) | Tampa | Florida | 33616 | — |
| Emory University Hospital, The Emory Clinic | Atlanta | Georgia | 30322 | — |
| Augusta University | Augusta | Georgia | 30312 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| University Of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Johns Hopkins Medicine - Johns Hopkins Myositis Center | Baltimore | Maryland | 21224 | — |
| Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC) | Boston | Massachusetts | 02115-6110 | — |
| Michigan State University - Neurology | East Lansing | Michigan | 48824 | — |
| St. Paul Rheumatology, PA | Saint Paul | Minnesota | 55121 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Northwell Health | Great Neck | New York | 11021 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| University of North Carolina (UNC) School of Medicine | Chapel Hill | North Carolina | 27514-4220 | — |
| Carolina Arthritis Associates | Wilmington | North Carolina | 28401 | — |
| Cleveland Clinic - Main Campus | Cleveland | Ohio | 44195 | — |
| The Ohio State University | Columbus | Ohio | 43201 | — |
| Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology | Oklahoma City | Oklahoma | 73120 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15261 | — |
| Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic | Nashville | Tennessee | 37232-0028 | — |
| Austin Neuromuscular Center | Austin | Texas | 78759 | — |
| McGovern Medical School -The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Nerve And Muscle Center Of Texas | Houston | Texas | 77030 | — |
| University of Vermont Medical Center - Main Campus | Burlington | Vermont | 05401 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 162 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05523167, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05523167 live on ClinicalTrials.gov.