A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEli Lilly and Company

About this trial

The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m²), inclusive.

Are 18 to 75 years of age, inclusive.

Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg/m², inclusive.

Have a clinical diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 6 months prior to screening.

Disqualifiers

Have known allergies to LY4298445, related compounds, or any components of the formulation

Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1.

Have severe active lupus-associated renal disease (lupus nephritis) defined clinically and/or by

urine protein/creatinine ratio greater than 200 milligrams per millimole (mg/mmol) (as an estimate of approximate proteinuria greater than 2 reams (g) per day) or

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4298445

    Drug

    Administered SC

  • LY4298445

    Drug

    Administered IV

Treatment groups

68 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: LY4298445 (Part A1)Experimental treatment 1 intervention
Group B: LY4298445 Placebo (Part A1)Placebo comparator 1 intervention
Group C: LY4298445 (Part A2)Experimental treatment 1 intervention
Group D: LY4298445 (Part B)Experimental treatment 1 intervention
Group E: LY4298445 (Part C)Experimental treatment 1 intervention
Group F: LY4298445 Placebo (Part C)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Time frame
Baseline up to Week 52

Secondary outcomes

1

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4298445

PK: AUC of LY4298445

Time frame
Baseline up to Approximately Week 57
2

PK: Maximum Concentration (Cmax) of LY4298445

PK: Cmax of LY4298445

Time frame
Baseline up to Week 52
3

Pharmacodynamic (PD): Degree of Peripheral B Cell Depletion Following Biopsy in Participants

PD: Peripheral B cell depletion

Time frame
Baseline up to Week 52

Other outcomes

Sponsors and contacts

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