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

NCT06189495

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

EvaluationDrugModalityDoseRoute
Subject Genakumab Monoclonal antibody 300 mg Subcutaneous