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

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)

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: YRA-1909 low dose; Drug: YRA-1909 mid dose; Drug: YRA-1909 high dose

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hanllym University Medical Center
  • Chungju, Korea, Republic of
    • Chungbuk National University Hospital
  • Daegu, Korea, Republic of
    • Kelmyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Gangdong, Korea, Republic of
    • Kyung Hee University Hospital at Gangdong
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • KyungHee University Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of
    • Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 110744
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YRA-1909 low dose	Drug: Placebo; Matching placebo dosing with daily oral intake for 12 weeks; Drug: YRA-1909 low dose; A low dose of YRA-1909; daily oral intake for 12 weeks
Experimental: YRA-1909 medium does	Drug: Placebo; Matching placebo dosing with daily oral intake for 12 weeks; Drug: YRA-1909 mid dose; A mid dose of YRA-1909; daily oral intake for 12 weeks
Experimental: YRA-1909 high dose	Drug: YRA-1909 high dose; A high dose of YRA-1909; daily oral intake for 12 weeks
Placebo Comparator: YRA-1909 Placebo	Drug: Placebo; Matching placebo dosing with daily oral intake for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
ACR20 Response at Week 4,8	Week 4 and 8
Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12	Week 4,8 and 12
ACR 50, 70 Response at Week 4, 8 and 12	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	Week 4, 8 and 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12	Week 4, 8 and 12
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12	Weeks 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	Week 4, 8 and 12

Collaborators and Investigators

• Sponsor: Yungjin Pharm. Co., Ltd.
• Investigators: Study Chair: YeongWook Song, M.D.,Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): November 19, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: YJ15-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No