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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Systemic Sclerosis Associated Interstitial Lung Disease, Rheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD), Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

In brief

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)

Key facts

Study ID

NCT06189495

Run by

Changchun GeneScience Pharmaceutical Co., Ltd.

People needed

30

Starts

2023-12-30

Expected to finish

2026-10-31

Last updated by the study team

2025-01-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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