Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 June 2021
• Main ID: NCT02919475
• Date of registration: 27/09/2016
• Prospective Registration: No
• Primary sponsor: Akros Pharma Inc.
• Public title: Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis MOVE-RA
• Scientific title: A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA)
• Date of first enrolment: September 14, 2016
• Target sample size: 260
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02919475
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Bulgaria, Colombia, Mexico, Peru, Poland, Romania, Russian Federation, Ukraine, United States

Contacts

• Name: Yoshiro Masuda
• Affiliation: Akros Pharma Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- A diagnosis of RA prior to the Screening Visit.

- Active disease despite ongoing therapy with up to two non-biologic disease-modifying
anti-rheumatic drugs, including methotrexate at both the Screening and Baseline
Visits.

- Screening hs-CRP =1.2 x upper limit of normal (ULN).

Exclusion Criteria:

- Prior/current exposure to biologic and/or kinase inhibitor therapy.

- Known history or presence of polyneuropathy of any cause and no presence of clinically
active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.

- Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or
hepatitis C (HCV) virus at the Screening Visit.

- Positive drug of abuse and alcohol test results.

- History of a clinically-significant infection that required oral antimicrobial or
antiviral therapy within 8 weeks prior to Day 1.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: JTE-051

Drug: Placebo

Primary Outcome(s)

Percentage of Subjects Achieving at Least 20% Improvement From Baseline in American College of Rheumatology (ACR) Core Set Measures (ACR20 Response Rate) Compared to Placebo at End-of-treatment (EOT) [Time Frame: Up to 12 Weeks]

Secondary Outcome(s)

Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12 [Time Frame: Week 12]

Number of Subjects With Treatment-related Adverse Events [Time Frame: Up to 16 Weeks]

Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12 [Time Frame: Week 12]

Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 [Time Frame: Week 12]

Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12 [Time Frame: Week 12]

Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12 [Time Frame: Week 12]

Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 [Time Frame: Week 12]

Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12 [Time Frame: Week 12]

Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12 [Time Frame: Week 12]

Secondary ID(s)

AE051-G-13-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/06/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02919475