A Study of LY3462817 in Participants With Rheumatoid Arthritis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04634253
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Czechia, Hungary, Mexico, Poland, Puerto Rico, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: LY3462817 Low Dose

LY3462817 given intravenously (IV).

Experimental: LY3462817 High Dose

LY3462817 given IV.

Placebo Comparator: Placebo

Placebo given IV.

Interventions

Drug: - Placebo

Given IV

Drug: - LY3462817

Given IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mesa, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, 85210

Site Contact

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