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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03275025

Enrollment

116

Registered

2017-09-07

Start date

2017-04-01

Completion date

2019-11-19

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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).

Interventions

DRUGYRA-1909 low dose

A low dose of YRA-1909; daily oral intake for 12 weeks

DRUGYRA-1909 mid dose

A mid dose of YRA-1909; daily oral intake for 12 weeks

DRUGYRA-1909 high dose

A high dose of YRA-1909; daily oral intake for 12 weeks

DRUGPlacebo

Matching placebo dosing with daily oral intake for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
ACR20 Response at Week 4,8	Week 4 and 8
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
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12	Week 4, 8 and 12
Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12	Week 4,8 and 12

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026