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

NCT05516758

TerminatedPhase 2

Sponsor: Eli Lilly and Company

Conditions: Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases

Interventions: Peresolimab, Placebo

Countries: United States, Argentina, Canada, China, Greece, Hungary, Japan, Mexico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (131)
  • Birmingham, Alabama, United States
  • Gilbert, Arizona, United States
  • Glendale, Arizona, United States
  • Mesa, Arizona, United States
  • Phoenix, Arizona, United States
  • Covina, California, United States
  • Fullerton, California, United States
  • Huntington Beach, California, United States
  • Rancho Mirage, California, United States
  • Tujunga, California, United States
  • Tustin, California, United States
  • Whittier, California, United States
  • Denver, Colorado, United States
  • Fort Collins, Colorado, United States
  • Avon Park, Florida, United States
  • Boynton Beach, Florida, United States
  • Clearwater, Florida, United States
  • New Port Richey, Florida, United States
  • St. Petersburg, Florida, United States
  • Tamarac, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Hinsdale, Illinois, United States
  • Lake Charles, Louisiana, United States
  • Bay City, Michigan, United States
  • Grand Blanc, Michigan, United States
  • Rochester Hills, Michigan, United States
  • Springfield, Missouri, United States
  • + 101 more on CT.gov