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Completed

NCT Number: NCT05848258

An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CENUDIAB, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3871801

Drug

Administered orally

Placebo

Drug

Administered orally

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Rigel Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 8, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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