CClinicalTrials.gg
CompletedNCT05848258Updated May 22, 2026

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

A Phase 2 interventional study of LY3871801 and Placebo in Rheumatoid Arthritis, sponsored by Eli Lilly and Company. Completed at 54 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's enrollment of 164 is above the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    LY3871801 Phase 2a

    Participants will receive LY3871801 administered orally.

    Drug: LY3871801

  • Placebo comparator
    Placebo Phase 2a

    Participants will receive placebo.

    Drug: Placebo

  • Experimental
    LY3871801 Dose 1 Phase 2b

    Participants will receive LY3871801 administered orally.

    Drug: LY3871801

  • Experimental
    LY3871801 Dose 2 Phase 2b

    Participants will receive LY3871801 administered orally.

    Drug: LY3871801

  • Experimental
    LY3871801 Dose 3 Phase 2b

    Participants will receive LY3871801 administered orally.

    Drug: LY3871801

  • Placebo comparator
    Placebo Phase 2b

    Participants will receive placebo.

    Drug: Placebo

Interventions

  • DrugLY3871801

    Administered orally

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline to Week 12

Secondary outcomes

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

    Time frame: Baseline to Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 12

  15. Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801

    Time frame: Baseline through Week 20

07

Study locations

54 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
  • Willow Rheumatology and Wellness PLLC
    Willowbrook, Illinois 60527, 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
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, 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
  • CIPREC
    Buenos Aires, C1061AAS, Argentina
  • Mautalen Salud e Investigación
    Buenos Aires, C1128AAF, Argentina
  • CENUDIAB
    Buenos Aires, C1440AAD, Argentina
  • Medicina Reumatológica
    San Fernando, 1646, Argentina
  • Instituto de Alta Complejidad San Isidro
    San Isidro, 1642, Argentina
  • Medical Plus
    Uherské Hradiště, 686 01, Czechia
  • CHD Vendee
    La Roche-sur-Yon, 85000, France
  • CHU Montpellier Lapeyronie Hospital
    Montpellier, 34295, France
  • CHU de Nice
    Nice, 06000, France
  • Centre Hospitalier Regional D'Orleans
    Orléans, 45067, France
  • Hopitaux Universitaires Paris Centre-Hopital Cochin
    Paris, 75679, France
  • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche
    Reims, 51092, France
  • CHU Strasbourg-Hautepierre
    Strasbourg, 67098, France
  • Universitaetsklinikum Koeln
    Cologne, 50937, Germany
  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH / -T
    Hamburg, 20095, Germany
  • Revita Clinic
    Budapest, 1027, Hungary
  • Óbudai Egészségügyi Centrum
    Budapest, 1036, Hungary
  • CRU Hungary Kft.
    Encs, 3860, Hungary
  • Vásárhelyi Sárkányfű KFT
    Hódmezővásárhely, 6800, Hungary
  • Kistarcsai Flor Ferenc Korhaz
    Kistarcsa, 2143, Hungary
  • Regia Med Kft
    Székesfehérvár, 8000, Hungary
  • Vital Medical Center
    Veszprém, 8200, Hungary
  • Avron Hospitals
    Ahmedabad, 380013, India
  • Sushruta Multispeciality Hospital & Research Centre
    Hubli, 580021, India
  • All India Institute of Medical Sciences (AIIMS) - Nagpur
    Nagpur, 441108, India
  • Grant Medical Foundation - Ruby Hall Clinic
    Pune, 411001, India
  • Medipoint Hospitals Pvt. Ltd.
    Pune, 411007, India
  • Investigacion y Biomedicina de Chihuahua
    Chihuahua City, 31000, Mexico
  • Hospital Aranda de La Parra
    León, 37000, Mexico
  • Biológicos Especializados
    Mexico City, 06700, Mexico
  • Kohler and Milstein Research S.A. de C.V.
    Mérida, 97070, Mexico
  • Medical Care and Research SA de CV
    Mérida, 97070, Mexico
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    Monterrey, 66460, Mexico
  • Cicmex Centro de Investigación Clínica de México
    Morelia, 58020, Mexico
  • Centro de Atención e Investigación Cardiovascular del Potosí
    San Luis Potosí City, 78200, Mexico
  • CIMAB SA de CV
    Torreón, 27000, Mexico
  • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
    Bialystok, 15-707, Poland
  • Nzoz Bif-Med
    Bytom, 41-902, Poland
  • MICS Centrum Medyczne Warszawa
    Warsaw, 00-874, Poland
  • Centrum Medyczne Reuma Park
    Warsaw, 02-665, Poland
  • Hull Royal Infirmary
    Hull, HU3 2JZ, United Kingdom
  • New Cross Hospital
    Wolverhampton, WV10 0QP, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05848258
Lead sponsor
Eli Lilly and Company
Collaborators
Rigel Pharmaceuticals
Responsible party
Sponsor
First posted
May 8, 2023
Start date
May 23, 2023
Primary completion
Dec 8, 2025
Completion
Apr 22, 2026
Last update
May 22, 2026

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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