A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

Study Purpose

The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.

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 rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.

- Have moderately-to-severely active RA, at screening and baseline, defined by the presence of.

- ≥6 swollen joints based on 66 joint count, and.

- ≥6 tender joints based on 68 joint count.

- Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.

Exclusion Criteria:

- Have Class IV RA according to ACR revised criteria.

- Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to.

- poorly controlled diabetes or hypertension.

- chronic kidney disease stage IIIb, IV, or V.

- symptomatic heart failure according to New York Heart Association Class II, III, or IV.

- myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization.

- severe chronic pulmonary disease, for example, requiring oxygen therapy.

- major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to, - systemic lupus erythematosus.

- psoriatic arthritis.

- axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis.

- reactive arthritis.

- gout.

- scleroderma.

- polymyositis.

- dermatomyositis.

- active fibromyalgia, or.

- multiple sclerosis

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.	NCT05516758
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	Argentina, Canada, China, Greece, Hungary, Italy, Japan, Mexico, Poland, Puerto Rico, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Peresolimab Dose 1

Participants will be given peresolimab by subcutaneous injection.

Experimental: Peresolimab Dose 2

Participants will be given peresolimab by subcutaneous injection.

Experimental: Peresolimab Dose 3

Participants will be given peresolimab by subcutaneous injection.

Active Comparator: Placebo

Participants will be give placebo by subcutaneous injection.

Interventions

Drug: - Peresolimab

Administered subcutaneously (SC)

Drug: - Placebo

Administered SC

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.

Birmingham, Alabama

Status

Recruiting

Address

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, 35216

Site Contact

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