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)

Eli Lilly Japan K.K.0 个研究点开始时间: 2017年7月10日最近更新: 2023年10月17日

适应症

试验速览

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•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)

•- 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

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