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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: KN019, 5mg/kg; Biological: Placebo; Biological: KN019, 10 mg/kg; Combination Product: Methotrexate

• Registration Number: NCT04038970
• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Study Start: 2019-11-08
• Primary Completion: 2022-07-28
• Study Completion: 2022-07-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis (RA) by satisfying at least four of the seven criteria;

• Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 7.5-25 mg, and a stable dose for 28 days prior to treatment (Day 1)

• The patient must have active disease at both screening and baseline, as defined by having both:

  6 tender/painful joints on motion (out of 68 joints assessed); and; 6 swollen joints (out of 66 joints assessed); CRP ≥ 7 mg/L, or ESR ≥28 mm/h

Key

Exclusion Criteria

• Pregnant or lactating females.
• History of any other autoimmune rheumatic disease.
• Patients who have previously received CTLA4-Ig therapy for any reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KN019 5mg/kg	KN019, 5mg/kg	Intravenous (IV) solution, 5 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
KN019 5mg/kg	Methotrexate	Intravenous (IV) solution, 5 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Placebo	Methotrexate	Intravenous (IV) solution, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
KN019 10mg/kg	Methotrexate	Intravenous (IV) solution, 10 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Placebo	Placebo	Intravenous (IV) solution, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
KN019 10mg/kg	KN019, 10 mg/kg	Intravenous (IV) solution, 10 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months

Primary Outcome Measures

Name	Time	Method
Percentage of Participants the proportion of subjects meeting the American College of Rheumatology criteria for 20% improvement (ACR 20) on Day 169	At Day 169	The ACR 20 is based on 20% improvement (compared with baseline values) in tender and swollen joint counts and on 20% improvement in 3 of the remaining 5 core set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function) and 1 acute phase reactant value.

Trial Locations

Locations (1)

Pingxiang people's hospital; 🇨🇳 PingXiang, Pingxiang, China