A Study of LY3462817 in Participants With Rheumatoid Arthritis

• Status: Recruiting
• Trial end date: 2022-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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)