A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Saf
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)
| Condition(s) | Systemic Sclerosis Associated Interstitial Lung Disease, Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD), Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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) |
| Who can participate | Inclusion Criteria: 1. Those who voluntarily sign informed consent and can complete the experiment according to the plan; 2. Age 18-75 years old (including upper and lower limits), both male and female; 3. Rheumatoid arthritis (RA) diagnosed according to the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) classification, or Systemic sclerosis (SSc) according to the 2013 ACR/EULAR classification; 4. Interstitial lung disease (ILD) was confirmed by HRCT within 12 months before screening. 5. FVC≥ 40% of the expected value during the screening period; 6. DLCO (using hemoglobin correction) ≥ 40% of the expected value during the screening period; 7. Patients may receive 1 immunosuppressant and must maintain a stable dose for 3 months prior to the first dose |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Locations | Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Jinan, Shandong, China; Chengdu, Sichuan, China |
| Start date | 2023-12-30 |
| NCT ID | NCT06189495 |
| Official listing | https://clinicaltrials.gov/study/NCT06189495 |