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Rheumatoid ArthritisPhase 2NCT05848258

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

A Phase 2 study testing LY3871801 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 54 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
LY3871801
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
54 sitesin 10 countries
Study dates
23 May 2023to 22 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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 locations and contacts

54 sites in 10 countries.

54 sites in 10 countries

United States12 sites

  • Overlake Arthritis and Osteoporosis Center

    Bellevue, Washington, 98004

  • Joseph S. and Diane H. Steinberg Ambulatory Care Center

    Brooklyn, New York, 11201

  • Integrity Clinical Research

    Doral, Florida, 33122

  • Accurate Clinical Research, Inc

    Houston, Texas, 77089

  • Newport Huntington Medical Group

    Huntington Beach, California, 92648

  • Accurate Clinical Research, Inc

    Lake Charles, Louisiana, 70605

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Advanced Clinical Research of Orlando - Ocoee

    Ocoee, Florida, 34761

  • Accellacare - Salisbury

    Salisbury, North Carolina, 28144

  • Encore Medical Research - Weston

    Weston, Florida, 33331

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

Mexico9 sites

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua City, 31000

  • Hospital Aranda de La Parra

    León, 37000

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

    Mérida, 97070

  • Medical Care and Research SA de CV

    Mérida, 97070

  • Biológicos Especializados

    Mexico City, 06700

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, 66460

  • Cicmex Centro de Investigación Clínica de México

    Morelia, 58020

  • Centro de Atención e Investigación Cardiovascular del Potosí

    San Luis Potosí City, 78200

  • CIMAB SA de CV

    Torreón, 27000

Other trials in Mexico

France7 sites

  • CHD Vendee

    La Roche-sur-Yon, 85000

  • CHU Montpellier Lapeyronie Hospital

    Montpellier, 34295

  • CHU de Nice

    Nice, 06000

  • Centre Hospitalier Regional D'Orleans

    Orléans, 45067

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris, 75679

  • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche

    Reims, 51092

  • CHU Strasbourg-Hautepierre

    Strasbourg, 67098

Other trials in France

Hungary7 sites

  • Revita Clinic

    Budapest, 1027

  • Óbudai Egészségügyi Centrum

    Budapest, 1036

  • CRU Hungary Kft.

    Encs, 3860

  • Vásárhelyi Sárkányfű KFT

    Hódmezővásárhely, 6800

  • Kistarcsai Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Regia Med Kft

    Székesfehérvár, 8000

  • Vital Medical Center

    Veszprém, 8200

Other trials in Hungary

Argentina5 sites

  • CIPREC

    Buenos Aires, C1061AAS

  • Mautalen Salud e Investigación

    Buenos Aires, C1128AAF

  • CENUDIAB

    Buenos Aires, C1440AAD

  • Medicina Reumatológica

    San Fernando, 1646

  • Instituto de Alta Complejidad San Isidro

    San Isidro, 1642

Other trials in Argentina

India5 sites

  • Avron Hospitals

    Ahmedabad, 380013

  • Sushruta Multispeciality Hospital & Research Centre

    Hubli, 580021

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, 441108

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, 411001

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007

Other trials in India

Poland4 sites

  • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, 15-707

  • Nzoz Bif-Med

    Bytom, 41-902

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

  • Centrum Medyczne Reuma Park

    Warsaw, 02-665

Other trials in Poland

Germany2 sites

  • Universitaetsklinikum Koeln

    Cologne, 50937

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

    Hamburg, 20095

Other trials in Germany

United Kingdom2 sites

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Czechia1 site

  • Medical Plus

    Uherské Hradiště, 686 01

Other trials in Czechia

About this study

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

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).

Being tested
LY3871801, Placebo
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3871801Drug

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT05848258
Study groupRoleWhat they receive
LY3871801 Phase 2aExperimentalParticipants will receive LY3871801 administered orally.
Receives: Drug: LY3871801
Placebo Phase 2aPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo
LY3871801 Dose 1 Phase 2bExperimentalParticipants will receive LY3871801 administered orally.
Receives: Drug: LY3871801
LY3871801 Dose 2 Phase 2bExperimentalParticipants will receive LY3871801 administered orally.
Receives: Drug: LY3871801
LY3871801 Dose 3 Phase 2bExperimentalParticipants will receive LY3871801 administered orally.
Receives: Drug: LY3871801
Placebo Phase 2bPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)

    Measured: Baseline, Week 12

  2. Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50

    Measured: Baseline to Week 12

Secondary outcomes (15)

  1. Phase 2a: Percentage of Participants Achieving ACR20/50/70

    Measured: Baseline to Week 12

  2. Phase 2b: Change from Baseline in DAS28-hsCRP

    Measured: Baseline, Week 12

  3. Phase 2b: Percentage of Participants Achieving ACR20/70

    Measured: Week 12

  4. Change from Baseline in Simplified Disease Activity Index (SDAI)

    Measured: Baseline, Week 12

  5. Change from Baseline in Clinical Disease Activity Index (CDAI)

    Measured: Baseline, Week 12

  6. Change from Baseline in ACR Core Set Values 68 Tender Joint Counts

    Measured: Baseline, Week 12

  7. Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts

    Measured: Baseline, Week 12

  8. Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS)

    Measured: Baseline, Week 12

  9. Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS

    Measured: Baseline, Week 12

  10. Change from Baseline for Participant's Assessment of Arthritis Pain (VAS)

    Measured: Baseline, Week 12

  11. Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)

    Measured: Baseline, Week 12

  12. Change from Baseline the Duration and Severity of Morning Joint Stiffness

    Measured: Baseline, Week 12

  13. Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score

    Measured: Baseline, Week 12

  14. Change from Baseline for SF-36 Mental Component Summary Score

    Measured: Baseline, Week 12

  15. Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801

    Measured: Baseline through Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2023
  2. Study start23 May 2023
  3. Primary completion8 Dec 2025
  4. Study completion22 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05848258
Sponsor's protocol ID
18516
Other IDs
J3P-MC-FTAF, 2022-502994-40-00
Status last verified
May 2026
First submitted
28 Apr 2023
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3871801 in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 54 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Mexico, France, Hungary, Argentina and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05848258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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