A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects With Rheumatoid Arthritis: The RAjuvenate Study (I8K-MC-JPDA)

Phase 2

• Conditions: Rheumatoid Arthritis

• Registration Number: JPRN-jRCT2080223586
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:
- Female subjects of childbearing potential test negative for pregnancy at screening and agree not to breastfeed
- Female subjects: agree to use a reliable method of birth control from the start of screening until 28 days after the last dose of study drug or be of nonchildbearing potential
- Male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy
- Have a diagnosis of RA based on the 2010 ACR/European League against Rheumatism criteria
- Have at least 1 of the following:
-- rheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR
-- radiographs documenting bony erosions
- Have active RA, defined as:
-- Part A: >=3 swollen joints (based on 66-joint counts)
-- Part B:
--- >=6 swollen joints (based on 66-joint counts)
--- >=6 tender joints (based on 68-joint counts)
--- hsCRP levels greater than the upper limit of normal (ULN) OR positive for ACPA
- Part B only: Have had inadequate response, loss of response, or intolerance to at least 1 synthetic OR biologic disease-modifying antirheumatic drug (DMARD)

Exclusion Criteria

- Have received any of the following:
-- Part B only: any prior treatment with a product directly targeting Bruton's tyrosine kinase (BTK) (marketed or investigational)
-- belimumab, natalizumab, or vedolizumab within 6 months prior to baseline
-- B-cell-depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-CD3 antibody) within 12 months prior to screening for Part A or at any time prior to screening for Part B
- Have known hypogammaglobulinemia
- Have hepatitis C virus, hepatitis B virus or human immunodeficiency virus
- Have active tuberculosis (TB)
- Are at high risk of infection or have recent evidence of clinically significant infection
- Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for treated basal cell or squamous epithelial carcinomas of the skin
- Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to receive one during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified