drugset / Trial / NCT05523167
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
RandomizedParallel-groupDouble-blindTreatment
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/.
Timeline
- Start
- 2022-10-12
- Primary completion
- 2026-12-01
- Completion
- 2027-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | — | Subcutaneous |
| Background | rHuPH20 | Protein / enzyme biologic | — | Subcutaneous |