drugset
drugset / Trial / NCT04038970

Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

NCT04038970 ↗

Phase 2 Completed 145 enrolled Jiangsu Alphamab Biopharmaceuticals Co., Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the efficacy, pharmacokinetics, safety, and immunogenicity of KN019 after intravenous administration on background methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate.

Timeline

Start
2019-11-08
Primary completion
2022-07-28
Completion
2022-07-28

Outcome

Met primary endpoint

release “KN019治疗甲氨蝶呤（MTX）应答不充分的活动性类风湿关节炎的Ⅱ期临床研究（研究编号：KN019-201）达到主要研究终点。” alphamabonc.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject KN019 Unknown 5 mg/kg Intravenous
Subject KN019 Unknown 10 mg/kg Intravenous
Background Methotrexate Small molecule 7.5 mg Oral
Background Methotrexate Small molecule 25 mg Oral

Indications

rheumatoid arthritis