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An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis

NCT05848258

CompletedPhase 2

Sponsor: Eli Lilly and Company

Conditions: Rheumatoid Arthritis

Interventions: LY3871801, Placebo

Countries: United States, Argentina, Czechia, France, Germany, Hungary, India, Mexico

The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Have a diagnosis of adult-onset 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 a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (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 IIIa or 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 (54)
  • Huntington Beach, California, United States
  • Doral, Florida, United States
  • Ocoee, Florida, United States
  • Weston, Florida, United States
  • Winter Park, Florida, United States
  • Willowbrook, Illinois, United States
  • Lake Charles, Louisiana, United States
  • Brooklyn, New York, United States
  • New York, New York, United States
  • Salisbury, North Carolina, United States
  • Houston, Texas, United States
  • Bellevue, Washington, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • San Fernando, Argentina
  • San Isidro, Argentina
  • Uherské Hradiště, Czechia
  • La Roche-sur-Yon, France
  • Montpellier, France
  • Nice, France
  • Orléans, France
  • Paris, France
  • Reims, France
  • Strasbourg, France
  • Cologne, Germany
  • Hamburg, Germany
  • Budapest, Hungary
  • Budapest, Hungary
  • Encs, Hungary
  • + 24 more on CT.gov