RecruitingPhase 2NCT06189495

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


Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

30 participants

Start Date

Dec 30, 2023

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study tests genakumab — a new injectable drug — in people with connective tissue disease (such as rheumatoid arthritis or systemic sclerosis) who have also developed interstitial lung disease (ILD), a condition where scar tissue builds up in the lungs and makes breathing difficult. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with rheumatoid arthritis (RA) or systemic sclerosis (SSc) using established medical criteria - You also have interstitial lung disease confirmed by a high-resolution CT scan of your chest - Your lung function has declined over time and you have moderate to severe lung involvement **You may NOT be eligible if...** - Your ILD is caused by something other than RA or systemic sclerosis - You have another serious lung condition (such as COPD or active tuberculosis) - You are pregnant or breastfeeding - You have a serious infection or immune system disorder Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGenSci048

1\. Dosage: 300 mg.2. Duration of administration: All subjects received one dose of Genakumab injection every 4 weeks according to their group.The dose was injected subcutaneously.3. Course of administration: Phase I subjects were treated with Genakumab injection until the end of the study or the occurrence of the drug.Tolerable toxicity or investigator-assessed efficacy (whichever occurs first); The phase 2 randomized double-blind treatment period was 24 weeks, with a total of 6 administration times. After the randomized double-blind treatment period, an open-label treatment period was entered, and all subjects will receive Genakumab injection 300 mg Q4W until the end of the study or the occurrence of intolerable toxicity or poor efficacy assessed by the investigators (whichever occurs first).4. Administration method: subcutaneous injection; The injection site is the abdomen (3 cm away from the navel

DRUGGenSci048 placebo

1\. Dosage: 300 mg.2. Duration of administration: All subjects received one dose of placebo every 4 weeks according to their group The dose was injected subcutaneously.3. Course of administration: Phase I subjects were treated with placebo until the end of the study or the occurrence of the drug.Tolerable toxicity or investigator-assessed efficacy (whichever occurs first); The phase 2 randomized double-blind treatment period was 24 weeks, with a total of 6 administration times. After the randomized double-blind treatment period, an open-label treatment period was entered, and all subjects will receive placebo 300 mg Q4W until the end of the study or the occurrence of intolerable toxicity or poor efficacy assessed by the investigators (whichever occurs first). 4\. Administration method: subcutaneous injection; The injection site is the abdomen (3 cm away from the navel)


Locations(4)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT06189495


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