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

Description

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).

Conditions

Rheumatoid Arthritis

Study Overview

Study Details

Study overview

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).

An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis

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

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Huntington Beach

Newport Huntington Medical Group, Huntington Beach, California, United States, 92648

Doral

Integrity Clinical Research, Doral, Florida, United States, 33122

Ocoee

Advanced Clinical Research of Orlando - Ocoee, Ocoee, Florida, United States, 34761

Weston

Encore Medical Research - Weston, Weston, Florida, United States, 33331

Winter Park

Conquest Research, Winter Park, Florida, United States, 32789

Blackfoot

Bingham Memorial Hospital, Blackfoot, Idaho, United States, 83221

Hinsdale

Hinsdale Orthopaedics - Illinois Bone & Joint Institute, Hinsdale, Illinois, United States, 60521

Lake Charles

Accurate Clinical Research, Inc, Lake Charles, Louisiana, United States, 70605

Brooklyn

Joseph S. and Diane H. Steinberg Ambulatory Care Center, Brooklyn, New York, United States, 11201

Salisbury

Accellacare - Salisbury, Salisbury, North Carolina, United States, 28144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-07