drugset / Trial / NCT06189495
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease
Phase 2
Recruiting
30 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
West China Hospital · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
This study was conducted in a randomized, double-blind, placebo-controlled design to evaluate the efficacy and safety of Genakumab injection in the treatment of CTD-ILD including Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD) and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)
Timeline
- Start
- 2023-12-30
- Primary completion
- 2026-03-31
- Completion
- 2026-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Genakumab | Monoclonal antibody | 300 mg | Subcutaneous |