Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Study to Evaluate 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
Researchers are evaluating the safety, tolerability, efficacy, and pharmacokinetics of Genakumab injection in adults aged 18 to 75 years with connective tissue disease-associated interstitial lung disease (CTD-ILD), including Rheumatoid Arthritis associated ILD and Systemic Sclerosis associated ILD. This is a randomized, double-blind, placebo-controlled Phase II clinical trial designed to assess Genakumab compared to placebo in this patient population. Participants receive subcutaneous injections of 300 mg of Genakumab or placebo every 4 weeks during a 24-week double-blind treatment period with six doses total. After this period, all subjects enter an open-label phase where they continue to receive Genakumab or placebo every 4 weeks until the study ends or intolerable toxicity or poor efficacy is observed. The injection is administered in the abdomen, approximately 3 cm away from the navel. During the study, lung function is regularly assessed by forced vital capacity (FVC) and diffusing capacity for carbon monoxide (DLCO) at specified intervals from screening through up to two years. Physician's Global Assessment scores are measured every 12 weeks. Safety is monitored by recording adverse events throughout the approximately two-year study duration. Participants undergo lung imaging, laboratory testing, and clinical evaluations to track efficacy and safety outcomes during treatment and follow-up.
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
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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
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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