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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT03275025
• Date of registration: 28/08/2017
• Prospective Registration: No
• Primary sponsor: Yungjin Pharm. Co., Ltd.
• Public title: A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
• Scientific 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)
• Date of first enrolment: April 1, 2017
• Target sample size: 116
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03275025
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: YeongWook Song, M.D.,Ph.D.
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion 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 ? 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



Age minimum: 19 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo

Drug: YRA-1909 mid dose

Drug: YRA-1909 low dose

Drug: YRA-1909 high dose

Primary Outcome(s)

American College of Rheumatology 20 (ACR20) response rate at Week 12 [Time Frame: Week 12]

Percentage of Participants With Adverse Events [Time Frame: Week 12]

Secondary Outcome(s)

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]

Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12 [Time Frame: 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 [Time Frame: Week 4, 8 and 12]

ACR 50, 70 Response at Week 4, 8 and 12 [Time Frame: Week 4, 8 and 12]

ACR20 Response at Week 4,8 [Time Frame: Week 4 and 8]

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]

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12 [Time Frame: Week 4, 8 and 12]

Secondary ID(s)

YJ15-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors