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

Study Purpose

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).

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 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

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.

NCT05848258
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, Czechia, France, Germany, India, Mexico, Slovakia, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: LY3871801 Phase 2a

Participants will receive LY3871801 administered orally.

Placebo Comparator: Placebo Phase 2a

Participants will receive placebo.

Experimental: LY3871801 Dose 1 Phase 2b

Participants will receive LY3871801 administered orally.

Experimental: LY3871801 Dose 2 Phase 2b

Participants will receive LY3871801 administered orally.

Experimental: LY3871801 Dose 3 Phase 2b

Participants will receive LY3871801 administered orally.

Placebo Comparator: Placebo Phase 2b

Participants will receive placebo.

Interventions

Drug: - LY3871801

Administered orally

Drug: - Placebo

Administered orally

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.

Integrity Clinical Research, Doral, Florida

Status

Active, not recruiting

Address

Integrity Clinical Research

Doral, Florida, 33122

Ocoee, Florida

Status

Active, not recruiting

Address

Advanced Clinical Research of Orlando - Ocoee

Ocoee, Florida, 34761

Conquest Research, Winter Park, Florida

Status

Recruiting

Address

Conquest Research

Winter Park, Florida, 32789

PMG Research of Salisbury, Salisbury, North Carolina

Status

Recruiting

Address

PMG Research of Salisbury

Salisbury, North Carolina, 28144

International Sites

Medicina Reumatológica, San Fernando, Buenos Aires, Argentina

Status

Recruiting

Address

Medicina Reumatológica

San Fernando, Buenos Aires, 1646

Instituto de Alta Complejidad San Isidro, San Isidro, Buenos Aires, Argentina

Status

Recruiting

Address

Instituto de Alta Complejidad San Isidro

San Isidro, Buenos Aires, 1642

CIPREC, Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Status

Recruiting

Address

CIPREC

Buenos Aires, Ciudad Autónoma De Buenos Aires, C1061AAS

Mautalen Salud e Investigación, Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Status

Recruiting

Address

Mautalen Salud e Investigación

Buenos Aires, Ciudad Autónoma De Buenos Aires, C1128AAF

CENUDIAB, Ciudad Autónoma de Buenos Aire, Argentina

Status

Recruiting

Address

CENUDIAB

Ciudad Autónoma de Buenos Aire, , C1440AAD

Medical Plus, Uherske Hradiste, Zlínský Kraj, Czechia

Status

Recruiting

Address

Medical Plus

Uherske Hradiste, Zlínský Kraj, 686 01

CHU de Nice, Nice, Alpes-Maritimes, France

Status

Recruiting

Address

CHU de Nice

Nice, Alpes-Maritimes, 06000

CHU Strasbourg-Hautepierre, Strasbourg, Alsace, France

Status

Recruiting

Address

CHU Strasbourg-Hautepierre

Strasbourg, Alsace, 67098

Centre Hospitalier Regional D'Orleans, Orléans, Centre, France

Status

Recruiting

Address

Centre Hospitalier Regional D'Orleans

Orléans, Centre, 45067

Reims, Champagne-Ardenne, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche

Reims, Champagne-Ardenne, 51092

Nîmes, Gard, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029

CHU Montpellier Lapeyronie Hospital, Montpellier, Hérault, France

Status

Recruiting

Address

CHU Montpellier Lapeyronie Hospital

Montpellier, Hérault, 34295

Infirmerie Protestante de Lyon, Caluire et Cuire, Rhône, France

Status

Recruiting

Address

Infirmerie Protestante de Lyon

Caluire et Cuire, Rhône, 69300

CHD Vendee, La Roche-sur-Yon, Vendée, France

Status

Recruiting

Address

CHD Vendee

La Roche-sur-Yon, Vendée, 85000

Paris, France

Status

Recruiting

Address

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, , 75679

Fraunhofer, Frankfurt, Hessen, Germany

Status

Recruiting

Address

Fraunhofer

Frankfurt, Hessen, 60596

Rheumazentrum Prof.Neeck MVZ, Bad Doberan, Mecklenburg-Vorpommern, Germany

Status

Recruiting

Address

Rheumazentrum Prof.Neeck MVZ

Bad Doberan, Mecklenburg-Vorpommern, 18209

University Hospital of Cologne, Köln, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

University Hospital of Cologne

Köln, Nordrhein-Westfalen, 50937

Rheumazentrum Ratingen Studienambulanz, Ratingen, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Rheumazentrum Ratingen Studienambulanz

Ratingen, Nordrhein-Westfalen, 40878

Magdeburg, Sachsen-Anhalt, Germany

Status

Recruiting

Address

Institut für Präventive Medizin & Klinische Forschung GbR

Magdeburg, Sachsen-Anhalt, 39110

Hamburg, Germany

Status

Recruiting

Address

HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH

Hamburg, , 20095

Avron Hospitals, Ahmedabad, Gujarat, India

Status

Recruiting

Address

Avron Hospitals

Ahmedabad, Gujarat, 380013

Hubli, Karnataka, India

Status

Recruiting

Address

Sushruta Multispeciality Hospital & Research Centre

Hubli, Karnataka, 580021

Nagpur, Maharashtra, India

Status

Recruiting

Address

Government Medical College And Hospital - Nagpur

Nagpur, Maharashtra, 440009

Nagpur, Maharashtra, India

Status

Recruiting

Address

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur, Maharashtra, 441108

Pune, Maharashtra, India

Status

Recruiting

Address

Grant Medical Foundation - Ruby Hall Clinic

Pune, Maharashtra, 411001

CIMAB SA de CV, Torreon, Coahuila, Mexico

Status

Recruiting

Address

CIMAB SA de CV

Torreon, Coahuila, 27000

Biológicos Especializados, Mexico City, Distrito Federal, Mexico

Status

Recruiting

Address

Biológicos Especializados

Mexico City, Distrito Federal, 06700

Hospital Aranda de La Parra, Leon, Guanajuato, Mexico

Status

Recruiting

Address

Hospital Aranda de La Parra

Leon, Guanajuato, 37000

Morelia, Michoacán, Mexico

Status

Recruiting

Address

Cicmex Centro de Investigación Clínica de México

Morelia, Michoacán, 58020

Monterrey, Nuevo León, Mexico

Status

Recruiting

Address

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, 66460

Medical Care and Research SA de CV, Merida, Yucatán, Mexico

Status

Recruiting

Address

Medical Care and Research SA de CV

Merida, Yucatán, 97070

Mérida, Yucatán, Mexico

Status

Recruiting

Address

Kohler and Milstein Research S.A. de C.V.

Mérida, Yucatán, 97070

Investigacion y Biomedicina de Chihuahua, Chihuahua, Mexico

Status

Recruiting

Address

Investigacion y Biomedicina de Chihuahua

Chihuahua, , 31000

Querétaro, Mexico

Status

Recruiting

Address

Estudios Clínicos Internacionales (ECI) - Querétaro

Querétaro, , 76000

San Luis Potosí, Mexico

Status

Recruiting

Address

Centro de Atención e Investigación Cardiovascular del Potosí

San Luis Potosí, , 78200

Cliniq s.r.o., Bratislava, Bratislavský Kraj, Slovakia

Status

Recruiting

Address

Cliniq s.r.o.

Bratislava, Bratislavský Kraj, 82119

The Dudley Group NHS Foundation Trust, Dudley, England, United Kingdom

Status

Recruiting

Address

The Dudley Group NHS Foundation Trust

Dudley, England, DY1 2HQ

Newcastle upon Tyne, North Tyneside, United Kingdom

Status

Recruiting

Address

Northumbria Healthcare NHS Foundation Trust

Newcastle upon Tyne, North Tyneside, NE29 8NH

New Cross Hospital, Wolverhampton, United Kingdom

Status

Recruiting

Address

New Cross Hospital

Wolverhampton, , WV10 0QP