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A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YRA-1909 low dose
YRA-1909 mid dose
YRA-1909 high dose
Placebo
Sponsored by
Yungjin Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 19 Years to 80 Years
  • Subjects with onset RA classified by ACR/EULAR 2010 revised classification criteria at least 12 weeks prior to screening
  • Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening

Exclusion Criteria:

  • Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class Ⅳ at screening

  • Any of the following laboratory values at screening:

    1. Patients with severe liver impairment (AST or ALT > 2 times the upper limit of normal)
    2. Patients with renal disease,immunodeficiency disease and peptic ulcer
    3. Patients with pleural effusion and ascites

Sites / Locations

  • Seoul National University Hospital
  • Hanllym University Medical Center
  • Chungbuk National University Hospital
  • Kelmyung University Dongsan Medical Center
  • Chungnam National University Hospital
  • Kyung Hee University Hospital at Gangdong
  • Chonnam National University Hospital
  • Gachon University Gil Medical Center
  • Chonbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Hanyang University Seoul Hospital
  • KyungHee University Hospital
  • Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

YRA-1909 low dose

YRA-1909 medium does

YRA-1909 high dose

YRA-1909 Placebo

Arm Description

Outcomes

Primary Outcome Measures

American College of Rheumatology 20 (ACR20) response rate at Week 12
Percentage of Participants With Adverse Events
Incidence of all grade adverse events

Secondary Outcome Measures

ACR20 Response at Week 4,8
Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12
ACR 50, 70 Response at Week 4, 8 and 12
Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12
Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator

Full Information

First Posted
August 28, 2017
Last Updated
April 29, 2021
Sponsor
Yungjin Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03275025
Brief Title
A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
November 19, 2019 (Actual)
Study Completion Date
November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yungjin Pharm. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YRA-1909 low dose
Arm Type
Experimental
Arm Title
YRA-1909 medium does
Arm Type
Experimental
Arm Title
YRA-1909 high dose
Arm Type
Experimental
Arm Title
YRA-1909 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YRA-1909 low dose
Intervention Description
A low dose of YRA-1909; daily oral intake for 12 weeks
Intervention Type
Drug
Intervention Name(s)
YRA-1909 mid dose
Intervention Description
A mid dose of YRA-1909; daily oral intake for 12 weeks
Intervention Type
Drug
Intervention Name(s)
YRA-1909 high dose
Intervention Description
A high dose of YRA-1909; daily oral intake for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo dosing with daily oral intake for 12 weeks
Primary Outcome Measure Information:
Title
American College of Rheumatology 20 (ACR20) response rate at Week 12
Time Frame
Week 12
Title
Percentage of Participants With Adverse Events
Description
Incidence of all grade adverse events
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
ACR20 Response at Week 4,8
Time Frame
Week 4 and 8
Title
Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12
Time Frame
Week 4,8 and 12
Title
ACR 50, 70 Response at Week 4, 8 and 12
Time Frame
Week 4, 8 and 12
Title
Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12
Time Frame
Week 4, 8 and 12
Title
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12
Time Frame
Week 4, 8 and 12
Title
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12
Time Frame
Weeks 4, 8 and 12
Title
Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator
Time Frame
Week 4, 8 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 19 Years to 80 Years Subjects with onset RA classified by ACR/EULAR 2010 revised classification criteria at least 12 weeks prior to screening Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening Exclusion Criteria: Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class Ⅳ at screening Any of the following laboratory values at screening: Patients with severe liver impairment (AST or ALT > 2 times the upper limit of normal) Patients with renal disease,immunodeficiency disease and peptic ulcer Patients with pleural effusion and ascites
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YeongWook Song, M.D.,Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Hanllym University Medical Center
City
Anyang
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Chungju
Country
Korea, Republic of
Facility Name
Kelmyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gangdong
City
Gangdong
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis

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