Back to resultsEfficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
KN019, 5mg/kg
KN019, 10 mg/kg
Placebo
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Pingxiang people's hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
KN019 5mg/kg
KN019 10mg/kg
Placebo
Arm Description
Intravenous (IV) solution, 5 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Intravenous (IV) solution, 10 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Intravenous (IV) solution, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04038970
First Posted
July 29, 2019
Last Updated
February 28, 2023
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04038970
Brief Title
Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KN019 5mg/kg
Arm Type
Experimental
Arm Description
Intravenous (IV) solution, 5 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Arm Title
KN019 10mg/kg
Arm Type
Experimental
Arm Description
Intravenous (IV) solution, 10 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous (IV) solution, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Intervention Type
Biological
Intervention Name(s)
KN019, 5mg/kg
Intervention Description
Solution, intravenous, 5 mg/kg
Intervention Type
Biological
Intervention Name(s)
KN019, 10 mg/kg
Intervention Description
Solution, intravenous, 10 mg/kg
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Solution, intravenous, Placebo
Intervention Type
Combination Product
Intervention Name(s)
Methotrexate
Intervention Description
Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition
Primary Outcome Measure Information:
Title
Percentage of Participants the proportion of subjects meeting the American College of Rheumatology criteria for 20% improvement (ACR 20) on Day 169
Description
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.
Time Frame
At Day 169
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pingxiang people's hospital
City
PingXiang
State/Province
Pingxiang
ZIP/Postal Code
337055
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
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