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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038970
• Other study ID #: KN019-201
• Status: Completed
• Phase: Phase 2
• Start date: November 8, 2019
• Est. completion date: July 28, 2022

Study information

• Verified date: February 2023
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• KN019, 5mg/kg
Solution, intravenous, 5 mg/kg
• KN019, 10 mg/kg
Solution, intravenous, 10 mg/kg
• Placebo
Solution, intravenous, Placebo

Combination Product:
• Methotrexate
Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition

Locations

Country	Name	City	State
China	Pingxiang people's hospital	PingXiang	Pingxiang

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants the proportion of subjects meeting the American College of Rheumatology criteria for 20% improvement (ACR 20) on 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.	At Day 169