Status:
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
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
West China Hospital
Conditions:
Systemic Sclerosis Associated Interstitial Lung Disease
Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Those who voluntarily sign informed consent and can complete the experiment according to the plan;
- Age 18-75 years old (including upper and lower limits), both male and female;
- 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;
- Interstitial lung disease (ILD) was confirmed by HRCT within 12 months before screening.
- FVC≥ 40% of the expected value during the screening period;
- DLCO (using hemoglobin correction) ≥ 40% of the expected value during the screening period;
- Patients may receive 1 immunosuppressant and must maintain a stable dose for 3 months prior to the first dose and agree to maintain a stable dose for at least 6 months after the first dose;
- Subjects of childbearing age who do not plan to become pregnant or donate sperm/eggs and agree to use reliable contraception during the period of participation in this trial and within 6 months after the last dosing.
Exclusion
- Allergic to experimental drugs or biological agents; People who have previously known other severe allergic reactions;
- Airway obstruction (FEV1/FVC\<0.7 before bronchodilator use) or other lung abnormalities deemed clinically significant by the investigator or a history of asthma;
- Those who have received any of the following drugs or treatments :
- Receiving prednisone \>15mg/ day or equivalent dose of glucocorticoid within 2 weeks prior to randomization;
- Receive azathioprine, colchicine, D-penicillamine, sulfasalazine within 8 weeks before randomization;
- received rituximab, tolizumab, nidanib, pirfenidone and other treatments within 6 months before randomization; Abacil, TNF inhibitors and other biologic agents were received within 3 months before randomization; Tofaciib, tacrolimus, cyclosporin A, and potassium para-aminobenzoate were used 30 days or 5 half-lives prior to screening, whichever was older.
- Combined with other rheumatic diseases, such as idiopathic inflammatory myopathy, systemic lupus erythematosus, Sjogren's syndrome, mixed connective tissue disease, systemic vasculitis;
- Significant pulmonary hypertension, meeting one of the following conditions:
- Previous clinical or echocardiographic evidence of significant right heart failure;
- Right cardiac catheterization showed cardiac index ≤ 2 l/min/m2;
- Pulmonary hypertension requiring extraenteral treatment with eprostol/traprostacycline;
- There are active bleeding diseases of internal organs, or have a serious bleeding tendency (such as hemophilia, etc.), or are undergoing anticoagulant treatment;
- There are infections requiring systemic drug control within 7 days prior to screening; Diagnosed with active tuberculosis infection;
- Have received live or attenuated vaccine within 3 months prior to screening, or plan to receive live or attenuated vaccine during the study period; Vaccination against COVID-19 within 2 weeks prior to screening;
- Previous stem cell therapy or any type of bone marrow transplant; Previous solid organ transplants; Long-term systemic use of glucocorticoids for other diseases;
- There is a history of serious immunodeficiency, or other acquired or congenital immunodeficiency diseases;
- History of malignant tumor within 5 years before screening;
- Recipients of kidney dialysis;
- Presence of the following clinically significant heart diseases:
- A history of chronic congestive heart failure, NYHA level IV; History of cardiac ejection fraction (EF) \< 30% by echocardiography;
- Myocardial infarction, acute coronary syndrome, viral myocarditis, and pulmonary embolism occurred within 3 months; Coronary revascularization was performed within 6 months.
- There are severe arrhythmias that require Class Ia or III antiarrhythmic drugs; Arrhythmias with diseased sinus syndrome, grade II type II or grade III atrioventricular block, and no pacemaker implanted;
- During the screening period, electrocardiogram indicated QTcF interval ≥ 480 ms (according to Fridericia correction formula, where QTcF=QT/RR\^0.33), or a history of prolonged QTc interval;
- There are the following abnormalities in the laboratory test values during the screening period:
- White blood cell count \<3×109/L, neutrophil count \<1.5×109/L;
- PLT\<75×109/L;
- Total bilirubin \>1.5×ULN, alanine aminotransferase (ALT) \>3×ULN, aspartate aminotransferase (AST) \>3×ULN;
- Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2;
- History or current positive results of serum virology tests:
- hepatitis B surface antigen positive, or hepatitis B core antibody positive and HBV-DNA higher than the detection limit;
- Hepatitis C virus (HCV) antibody positive;
- Positive for human immunodeficiency virus (HIV) antibodies;
- Those who are positive for treponema pallidum antibodies and need treatment for syphilis infection.
- Received treatment with any investigational drug or medical device in a clinical trial within 3 months prior to screening;
- Pregnancy test positive during screening period; Lactating women;
- The investigator assessed those who had other factors that made them unsuitable for participation in the trial
Key Trial Info
Start Date :
December 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06189495
Start Date
December 30 2023
End Date
October 31 2026
Last Update
January 17 2025
Active Locations (4)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
2
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
3
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250063
4
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610047