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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: LY3871801; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05848258

J3P-MC-FTAF (Other Identifier)

2022-502994-40-00 (Other Identifier)

18516

Details and patient eligibility

About

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).

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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380 participants in 6 patient groups, including a placebo group

LY3871801 Phase 2a

Experimental group

Description:

Participants will receive LY3871801 administered orally.

Treatment:

Drug: LY3871801

Placebo Phase 2a

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo

LY3871801 Dose 1 Phase 2b

Experimental group

Description:

Participants will receive LY3871801 administered orally.

Treatment:

Drug: LY3871801

LY3871801 Dose 2 Phase 2b

Experimental group

Description:

Participants will receive LY3871801 administered orally.

Treatment:

Drug: LY3871801

LY3871801 Dose 3 Phase 2b

Experimental group

Description:

Participants will receive LY3871801 administered orally.

Treatment:

Drug: LY3871801

Placebo Phase 2b

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo