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, Hungary, India, Mexico, Poland, 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.

Newport Huntington Medical Group, Huntington Beach 5358705, California 5332921

Status

Recruiting

Address

Newport Huntington Medical Group

Huntington Beach 5358705, California 5332921, 92648

Integrity Clinical Research, Doral 4153471, Florida 4155751

Status

Active, not recruiting

Address

Integrity Clinical Research

Doral 4153471, Florida 4155751, 33122

Ocoee 4166776, Florida 4155751

Status

Active, not recruiting

Address

Advanced Clinical Research of Orlando - Ocoee

Ocoee 4166776, Florida 4155751, 34761

Encore Medical Research - Weston, Weston 4178003, Florida 4155751

Status

Recruiting

Address

Encore Medical Research - Weston

Weston 4178003, Florida 4155751, 33331

Conquest Research, Winter Park 4178560, Florida 4155751

Status

Recruiting

Address

Conquest Research

Winter Park 4178560, Florida 4155751, 32789

Willow Rheumatology and Wellness PLLC, Willowbrook 4916709, Illinois 4896861

Status

Recruiting

Address

Willow Rheumatology and Wellness PLLC

Willowbrook 4916709, Illinois 4896861, 60527

Accurate Clinical Research, Inc, Lake Charles 4330236, Louisiana 4331987

Status

Recruiting

Address

Accurate Clinical Research, Inc

Lake Charles 4330236, Louisiana 4331987, 70605

Brooklyn 5110302, New York 5128638

Status

Recruiting

Address

Joseph S. and Diane H. Steinberg Ambulatory Care Center

Brooklyn 5110302, New York 5128638, 11201

Icahn School of Medicine at Mount Sinai, New York 5128581, New York 5128638

Status

Not yet recruiting

Address

Icahn School of Medicine at Mount Sinai

New York 5128581, New York 5128638, 10029

Accellacare - Salisbury, Salisbury 4489985, North Carolina 4482348

Status

Recruiting

Address

Accellacare - Salisbury

Salisbury 4489985, North Carolina 4482348, 28144

Accurate Clinical Research, Inc, Houston 4699066, Texas 4736286

Status

Recruiting

Address

Accurate Clinical Research, Inc

Houston 4699066, Texas 4736286, 77089

Bellevue 5786882, Washington 5815135

Status

Recruiting

Address

Overlake Arthritis and Osteoporosis Center

Bellevue 5786882, Washington 5815135, 98004

International Sites

CIPREC, Buenos Aires 3435910, Argentina

Status

Not yet recruiting

Address

CIPREC

Buenos Aires 3435910, , C1061AAS

Mautalen Salud e Investigación, Buenos Aires 3435910, Argentina

Status

Not yet recruiting

Address

Mautalen Salud e Investigación

Buenos Aires 3435910, , C1128AAF

CENUDIAB, Buenos Aires 3435910, Argentina

Status

Not yet recruiting

Address

CENUDIAB

Buenos Aires 3435910, , C1440AAD

Medicina Reumatológica, San Fernando 3429095, Argentina

Status

Recruiting

Address

Medicina Reumatológica

San Fernando 3429095, , 1646

Instituto de Alta Complejidad San Isidro, San Isidro 3428992, Argentina

Status

Not yet recruiting

Address

Instituto de Alta Complejidad San Isidro

San Isidro 3428992, , 1642

Medical Plus, Uherské Hradiště 3063739, Czechia

Status

Recruiting

Address

Medical Plus

Uherské Hradiště 3063739, , 686 01

CHD Vendee, La Roche-sur-Yon 3006767, France

Status

Recruiting

Address

CHD Vendee

La Roche-sur-Yon 3006767, , 85000

CHU Montpellier Lapeyronie Hospital, Montpellier 2992166, France

Status

Not yet recruiting

Address

CHU Montpellier Lapeyronie Hospital

Montpellier 2992166, , 34295

CHU de Nice, Nice 2990440, France

Status

Recruiting

Address

CHU de Nice

Nice 2990440, , 06000

Centre Hospitalier Regional D'Orleans, Orléans 2989317, France

Status

Recruiting

Address

Centre Hospitalier Regional D'Orleans

Orléans 2989317, , 45067

Paris 2988507, France

Status

Recruiting

Address

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris 2988507, , 75679

Reims 2984114, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche

Reims 2984114, , 51092

CHU Strasbourg-Hautepierre, Strasbourg 2973783, France

Status

Recruiting

Address

CHU Strasbourg-Hautepierre

Strasbourg 2973783, , 67098

Universitaetsklinikum Koeln, Cologne 2886242, Germany

Status

Completed

Address

Universitaetsklinikum Koeln

Cologne 2886242, , 50937

Hamburg 2911298, Germany

Status

Completed

Address

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

Hamburg 2911298, , 20095

Revita Clinic, Budapest 3054643, Hungary

Status

Recruiting

Address

Revita Clinic

Budapest 3054643, , 1027

Clinexpert Kft., Budapest 3054643, Hungary

Status

Recruiting

Address

Clinexpert Kft.

Budapest 3054643, , 1033

Óbudai Egészségügyi Centrum, Budapest 3054643, Hungary

Status

Recruiting

Address

Óbudai Egészségügyi Centrum

Budapest 3054643, , 1036

CRU Hungary Kft., Encs 721159, Hungary

Status

Recruiting

Address

CRU Hungary Kft.

Encs 721159, , 3860

Vásárhelyi Sárkányfű KFT, Hódmezővásárhely 719965, Hungary

Status

Recruiting

Address

Vásárhelyi Sárkányfű KFT

Hódmezővásárhely 719965, , 6800

Kistarcsai Flor Ferenc Korhaz, Kistarcsa 3050290, Hungary

Status

Recruiting

Address

Kistarcsai Flor Ferenc Korhaz

Kistarcsa 3050290, , 2143

Regia Med Kft, Székesfehérvár 3044774, Hungary

Status

Recruiting

Address

Regia Med Kft

Székesfehérvár 3044774, , 8000

Vital Medical Center, Veszprém 3042929, Hungary

Status

Not yet recruiting

Address

Vital Medical Center

Veszprém 3042929, , 8200

Avron Hospitals, Ahmedabad 1279233, India

Status

Recruiting

Address

Avron Hospitals

Ahmedabad 1279233, , 380013

Hubli 10434157, India

Status

Recruiting

Address

Sushruta Multispeciality Hospital & Research Centre

Hubli 10434157, , 580021

Nagpur 1262180, India

Status

Not yet recruiting

Address

Government Medical College And Hospital - Nagpur

Nagpur 1262180, , 440009

Nagpur 1262180, India

Status

Recruiting

Address

All India Institute of Medical Sciences (AIIMS) - Nagpur

Nagpur 1262180, , 441108

Pune 1259229, India

Status

Recruiting

Address

Grant Medical Foundation - Ruby Hall Clinic

Pune 1259229, , 411001

Medipoint Hospitals Pvt. Ltd., Pune 1259229, India

Status

Recruiting

Address

Medipoint Hospitals Pvt. Ltd.

Pune 1259229, , 411007

All India Institute of Medical Sciences, Raipur 1258980, India

Status

Recruiting

Address

All India Institute of Medical Sciences

Raipur 1258980, , 492099

Investigacion y Biomedicina de Chihuahua, Chihuahua City 4014338, Mexico

Status

Recruiting

Address

Investigacion y Biomedicina de Chihuahua

Chihuahua City 4014338, , 31000

Hospital Aranda de La Parra, León 9010779, Mexico

Status

Recruiting

Address

Hospital Aranda de La Parra

León 9010779, , 37000

Biológicos Especializados, Mexico City 3530597, Mexico

Status

Recruiting

Address

Biológicos Especializados

Mexico City 3530597, , 06700

Mérida 3523349, Mexico

Status

Recruiting

Address

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

Mérida 3523349, , 97070

Medical Care and Research SA de CV, Mérida 3523349, Mexico

Status

Recruiting

Address

Medical Care and Research SA de CV

Mérida 3523349, , 97070

Monterrey 3995465, Mexico

Status

Recruiting

Address

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey 3995465, , 66460

Morelia 3995402, Mexico

Status

Recruiting

Address

Cicmex Centro de Investigación Clínica de México

Morelia 3995402, , 58020

San Luis Potosí City 3985606, Mexico

Status

Recruiting

Address

Centro de Atención e Investigación Cardiovascular del Potosí

San Luis Potosí City 3985606, , 78200

CIMAB SA de CV, Torreón 3981254, Mexico

Status

Recruiting

Address

CIMAB SA de CV

Torreón 3981254, , 27000

Bialystok 776069, Poland

Status

Recruiting

Address

Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

Bialystok 776069, , 15-707

Nzoz Bif-Med, Bytom 3101950, Poland

Status

Recruiting

Address

Nzoz Bif-Med

Bytom 3101950, , 41-902

MICS Centrum Medyczne Warszawa, Warsaw 756135, Poland

Status

Recruiting

Address

MICS Centrum Medyczne Warszawa

Warsaw 756135, , 00-874

Centrum Medyczne Reuma Park, Warsaw 756135, Poland

Status

Recruiting

Address

Centrum Medyczne Reuma Park

Warsaw 756135, , 02-665

Hull Royal Infirmary, Hull 2645425, United Kingdom

Status

Not yet recruiting

Address

Hull Royal Infirmary

Hull 2645425, , HU3 2JZ

New Cross Hospital, Wolverhampton 2633691, United Kingdom

Status

Completed

Address

New Cross Hospital

Wolverhampton 2633691, , WV10 0QP