NCT04038970

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

A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to provide efficacy data in support of the proposed claims of reducing signs and symptoms, improvement in physical function, and 1 year safety data for KN019 dosed at 5 and 10 mg/kg in patients with inadequate response to stable weekly doses of background methotrexate.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	KN019, 5mg/kg	Solution, intravenous, 5 mg/kg
BIOLOGICAL	KN019, 10 mg/kg	Solution, intravenous, 10 mg/kg
BIOLOGICAL	Placebo	Solution, intravenous, Placebo
COMBINATION_PRODUCT	Methotrexate	Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition

Timeline

• Start date: 2019-11-08
• Primary completion: 2022-07-28
• Completion: 2022-07-28
• First posted: 2019-07-31
• Last updated: 2023-03-01

Locations

1 site across 1 country: China