Actively Recruiting
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
Led by Changchun GeneScience Pharmaceutical Co., Ltd. · Updated on 2025-01-17
30
Participants Needed
4
Research Sites
148 weeks
Total Duration
On this page
Sponsors
C
Changchun GeneScience Pharmaceutical Co., Ltd.
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study procedures
- Age between 18 and 75 years, inclusive, any gender
- Diagnosed with rheumatoid arthritis by 2010 ACR/EULAR criteria or systemic sclerosis by 2013 ACR/EULAR criteria
- Interstitial lung disease confirmed by high-resolution CT within 12 months before screening
- Forced vital capacity (FVC) at least 40% of expected value at screening
- Diffusing capacity for carbon monoxide (DLCO) at least 40% of expected value at screening
- Receiving one immunosuppressant medication at a stable dose for 3 months prior to first dose and agree to maintain stable dose for 6 months after first dose
- Of childbearing potential, agree to use reliable contraception during study and for 6 months after last dose
You will not qualify if you...
- Allergy to study drugs or biological agents or history of severe allergic reactions
- Airway obstruction (FEV1/FVC <0.7 before bronchodilator) or clinically significant lung abnormalities or history of asthma
- Use of prednisone >15 mg/day or equivalent within 2 weeks before randomization
- Use of certain immunosuppressive or biologic drugs (azathioprine, colchicine, D-penicillamine, sulfasalazine within 8 weeks; rituximab, tocilizumab, nidanib, pirfenidone within 6 months; other biologics within 3 months; other specified drugs within 30 days or 5 half-lives before screening)
- Presence of other rheumatic diseases such as idiopathic inflammatory myopathy, systemic lupus erythematosus, Sjogren's syndrome, mixed connective tissue disease, systemic vasculitis
- Significant pulmonary hypertension or right heart failure
- Active bleeding disorders or anticoagulant treatment
- Active infections requiring systemic treatment or active tuberculosis
- Live or attenuated vaccine within 3 months prior to screening or planned during study; COVID-19 vaccine within 2 weeks prior to screening
- Previous stem cell therapy or bone marrow transplant; prior solid organ transplant; long-term systemic glucocorticoid use for other diseases
- History of serious immunodeficiency or acquired/congenital immunodeficiency
- History of malignant tumor within 5 years before screening
- Receiving kidney dialysis
- Clinically significant heart diseases including severe heart failure, recent myocardial infarction, severe arrhythmias, prolonged QTc interval
- Laboratory abnormalities including low white blood cell or neutrophil counts, low platelet count, elevated liver enzymes, decreased kidney function
- Positive tests for hepatitis B or C, HIV, or active syphilis needing treatment
- Participation in other clinical trials with investigational drugs or devices within 3 months before screening
- Positive pregnancy test or lactating women
- Other factors deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
2
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
3
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250063
Actively Recruiting
4
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610047
Not Yet Recruiting
Research Team
S
shengnan wen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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