A Study of LY3462817 in Participants With Rheumatoid Arthritis

Lilly

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: LY3462817

Study type: Interventional

Funder types: Industry

Identifiers

NCT04634253

J1A-MC-KDAD (Other Identifier)

17424

2020-002673-10 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 3 patient groups, including a placebo group

LY3462817 300 mg

Experimental group

Description:

Participants received Intravenous (IV) infusion of 300 mg LY3462817 solution.

Treatment:

Drug: LY3462817

LY3462817 700 mg

Experimental group

Description:

Participants received IV infusion of 700 mg LY3462817 solution.

Treatment:

Drug: LY3462817

Placebo

Placebo Comparator group

Description:

Participants received IV infusion of 0.9% sodium chloride solution (Placebo).

Treatment:

Drug: Placebo