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

Phase 1

• Conditions: Moderately to Severely Active Rheumatoid Arthritis; MedDRA version: 23.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-002673-10-PL
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-19
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 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 or tsDMARDs (e.g. excluded if have failed 2 bDMARDs and 1 tsDMARD)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of LY3462817 in adult participants with moderately to severely active Rheumatoid Arthritis (RA);Secondary Objective: To describe the safety and tolerability of LY3462817 compared to placebo<br>To evaluate the effect of LY3462817 on measures of disease activity (ACR, SDAI, CDAI)<br>To describe the effect of LY3462817 on patient-reported outcomes (PROs)<br>To characterize the pharmacokinetics of LY3462817;Primary end point(s): Change from Baseline on the Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP);Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20), ACR50 and ACR70<br>• Change from Baseline for Mean Simplified Disease Activity Index (SDAI)<br>• Change from Baseline for Mean Clinical Disease Activity Index (CDAI)<br>• Change from Baseline on the 36 Item Short Form Health Survey (SF-36)<br>• Pharmacokinetics (PK): Observed Concentration of LY3462817;Timepoint(s) of evaluation of this end point: Week 12