A Study of LY3462817 in Participants With Rheumatoid Arthritis

A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis

The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).

Inclusion Criteria:

• Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening

• Have moderately to severely active RA defined by the presence of ≥6 swollen joints (based on 66 joint count) and ≥6 tender joints (based on 68 joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility

• Have at least 1 of the following:

  • positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at screening, OR
  • previous radiographs documenting bony erosions in hands or feet consistent with RA

• Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central laboratory at screening

• Demonstrated an inadequate response to, or loss of response or intolerance to:

  • at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment OR
  • at least 1 biologic DMARD/tsDMARD treatment

Exclusion Criteria:

• Class IV RA according to ACR revised response criteria

• Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of:

  • basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
  • cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline

• Have presence of confirmed cervical dysplasia

• Have had various types of infection within 3 months of screening or develops any of these infections before the randomization visit.

• Have any of the following:

  • Human immunodeficiency virus (HIV) infection
  • Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction (PCR) positive for HBV DNA
  • Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)
  • Active tuberculosis (TB)

• Have failed more than 2 biologic DMARDs (bDMARDs) or tsDMARDs (e.g. excluded if have received 2 bDMARDs and 1 tsDMARD)