30
Participants
Start Date
December 30, 2023
Primary Completion Date
March 31, 2026
Study Completion Date
October 31, 2026
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
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)"
RECRUITING
Peking University Third Hospital, Beijing
RECRUITING
Qilu Hospital of Shandong University, Jinan
RECRUITING
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan
NOT_YET_RECRUITING
West China Hospital of Sichuan University, Chengdu
West China Hospital
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY