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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038970
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: KN019, 5mg/kg Biological: KN019, 10 mg/kg Biological: Placebo Combination Product: Methotrexate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 8, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KN019 5mg/kg
Intravenous (IV) solution, 5 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Biological: KN019, 5mg/kg
Solution, intravenous, 5 mg/kg

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

Experimental: KN019 10mg/kg
Intravenous (IV) solution, 10 mg/kg, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Biological: KN019, 10 mg/kg
Solution, intravenous, 10 mg/kg

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

Placebo Comparator: Placebo
Intravenous (IV) solution, Day 1, Day 15, Day 29; every 28 days thereafter, 12 months
Biological: Placebo
Solution, intravenous, Placebo

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




Primary Outcome Measures :
  1. Percentage of Participants the proportion of subjects meeting the American College of Rheumatology criteria for 20% improvement (ACR 20) on Day 169 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038970


Contacts
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Contact: Jian kang Hu, Doctor 13879936380 ext +86 hjk0799@163.com

Locations
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China, Pingxiang
Pingxiang people's hospital Recruiting
PingXiang, Pingxiang, China, 337055
Contact: Jian Kang Hu, Doctor    13879936380 ext +86    hjk0799@163.com   
Sponsors and Collaborators
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
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Responsible Party: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier: NCT04038970    
Other Study ID Numbers: KN019-201
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors