Trials / Active Not Recruiting
Active Not RecruitingNCT05523167
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
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
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 265 (actual)
- Sponsor
- argenx · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Active Idiopathic Inflammatory Myopathy
- Myositis
- Dermatomyositis
- Polymyositis
- Immune-Mediated Necrotizing Myopathy
- Antisynthetase Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EFG PH20 SC | Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
| OTHER | PBO | Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer |
Timeline
- Start date
- 2022-10-12
- Primary completion
- 2026-12-01
- Completion
- 2027-02-01
- First posted
- 2022-08-31
- Last updated
- 2025-07-23
Locations
202 sites across 36 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Cyprus, Czechia, Denmark, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05523167. Inclusion in this directory is not an endorsement.