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

PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 30, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

October 31, 2026

Conditions
Systemic Sclerosis Associated Interstitial Lung DiseaseRheumatoid Arthritis Associated Interstitial Lung Disease (RA-ILD)Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Interventions
DRUG

GenSci048

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

DRUG

GenSci048 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)"

Trial Locations (4)

100191

RECRUITING

Peking University Third Hospital, Beijing

250063

RECRUITING

Qilu Hospital of Shandong University, Jinan

430022

RECRUITING

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

610047

NOT_YET_RECRUITING

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
collaborator

West China Hospital

OTHER

lead

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY