A Study of LY3337641 in Rheumatoid Arthritis

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

The main purpose of this study is to evaluate the safety and effectiveness of LY3337641 in adults with rheumatoid arthritis (RA).

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 American College of Rheumatology (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-cluster of differentiation 3 (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