Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated January 17, 2025 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
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)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-12-19.
Status change: Not Yet Recruiting → Recruiting 2025-01-16
Trial Details
NCT Number NCT06189495
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators: West China Hospital
Conditions Systemic Sclerosis Associated Interstitial Lung Disease, Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD), Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Enrollment 30 participants
Start Date 2023-12-30
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-17