RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-05-23

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05848258

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559

ClinicalTrials.gov@lilly.com

Principal Investigator

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 Locations (Sites)

Newport Huntington Medical Group

Huntington Beach, California, 92648

United States

Integrity Clinical Research

Doral, Florida, 33122

United States

Advanced Clinical Research of Orlando - Ocoee

Ocoee, Florida, 34761

United States

Encore Medical Research - Weston

Weston, Florida, 33331

United States

Conquest Research

Winter Park, Florida, 32789

United States

Bingham Memorial Hospital

Blackfoot, Idaho, 83221

United States

Hinsdale Orthopaedics - Illinois Bone & Joint Institute

Hinsdale, Illinois, 60521

United States

Accurate Clinical Research, Inc

Lake Charles, Louisiana, 70605

United States

Joseph S. and Diane H. Steinberg Ambulatory Care Center

Brooklyn, New York, 11201

United States

Accellacare - Salisbury

Salisbury, North Carolina, 28144

United States

Accurate Clinical Research, Inc

Houston, Texas, 77089

United States

Overlake Arthritis and Osteoporosis Center

Bellevue, Washington, 98004

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-23

Study Completion Date2026-07

Study Record Updates

Study Start Date2023-05-23

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

Rheumatoid Arthritis