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| Name | Class |
|---|---|
| West China Hospital | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GenSci048 | Experimental | 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 |
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| GenSci048 placebo | Placebo Comparator | .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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GenSci048 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function assessment:Subjects' lung function was assessed by FVC . | FVC will be evaluated simultaneously during the screening period, 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, and once every 24 weeks thereafter, From baseline up to 2 years | |
| Lung function assessment:Subjects' lung function was assessed by DLCO. | DLCO will be evaluated simultaneously during the screening period, 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, and once every 24 weeks thereafter, From baseline up to 2 years,early withdrawal/termination of treatment, and when the investigator deems | |
| tLung function assessment:Visual simulation score was used to evaluate Physician's Global Asseessment(PGA) | "Lung function assessment:The PGA is evaluated during the screening period and once every 12 weeks .From baseline up to 2 years. | |
| Safety evaluation indicator:Adverse Events | From baseline up to approximately 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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 :
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:
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:
There are the following abnormalities in the laboratory test values during the screening period:
History or current positive results of serum virology tests:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shengnan wen | Contact | 15130499319 | wenshengnan@gensci-china.com |
| Name | Affiliation | Role |
|---|---|---|
| qibing xie, Doctor of Medicine(M.D.) | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China | |
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| GenSci048 placebo | Drug | 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) |
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| Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology |
| Recruiting |
| Wuhan |
| Hubei |
| 430022 |
| China |
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250063 | China |
| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610047 | China |
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