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

NCT04038970 | Completed Phase 2

• 1 other identifier: KN019-201
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

KN019 5mg/kg

EXPERIMENTAL

Intravenous (IV) solution, 5 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months

Biological: KN019, 5mg/kg; Combination Product: Methotrexate

KN019 10mg/kg

EXPERIMENTAL

Intravenous (IV) solution, 10 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months

Biological: KN019, 10 mg/kg; Combination Product: Methotrexate

Placebo

PLACEBO COMPARATOR

Intravenous (IV) solution, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months

Biological: Placebo; Combination Product: Methotrexate

Interventions

KN019, 5mg/kg BIOLOGICAL

Solution, intravenous, 5 mg/kg

KN019 5mg/kg

KN019, 10 mg/kg BIOLOGICAL

Solution, intravenous, 10 mg/kg

KN019 10mg/kg

Placebo BIOLOGICAL

Solution, intravenous, Placebo

Placebo

Methotrexate COMBINATION_PRODUCT

Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition

KN019 10mg/kg; KN019 5mg/kg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Pingxiang people's hospital

Pingxiang, Pingxiang, 337055, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: November 8, 2019
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

CN (1)