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Monoclonal Antibodies

LY3361237 for Lupus

Phase 2
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be receiving at least 1 background standard-of-care medication for SLE
Be older than 18 years old
Must not have
Are currently receiving oral corticosteroids at doses >20 mg per day of prednisone (or equivalent) or have adjusted the dosage of corticosteroids within 2 weeks before starting study treatment
Have a current or recent acute, active infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24

Summary

This trial is testing a new medication called LY3361237 to see if it helps people with moderately active systemic lupus erythematosus (SLE). The study will last several months and include multiple visits. The goal is to find out if LY3361237 can reduce the symptoms and activity of SLE.

Who is the study for?
This trial is for individuals with moderately active systemic lupus erythematosus (SLE) who have been diagnosed at least 24 weeks prior and are on standard SLE medication. Participants must have certain scores indicating active disease but cannot be on high doses of corticosteroids or have had recent severe infections, HIV, hepatitis, TB, or significant cardiac events.
What is being tested?
The study tests the efficacy and safety of LY3361237 in managing SLE symptoms compared to a placebo. Over up to 34 weeks and possibly 15 visits, participants will receive either the investigational drug or a placebo while continuing their usual SLE treatments.
What are the potential side effects?
While specific side effects for LY3361237 aren't listed here, common side effects in trials like this may include injection site reactions, increased risk of infection due to immune system suppression, gastrointestinal issues, headaches, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission fo Arthritis and/or Rash
Secondary study objectives
Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response
Percentage of Participants who achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 response)
Pharmacokinetics (PK): Steady-state trough serum concentration of LY3361237

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3361237Experimental Treatment1 Intervention
Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC)
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered SC and SOC given at matching intervals
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3361237
2021
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,657 Previous Clinical Trials
3,224,805 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,380 Previous Clinical Trials
423,659 Total Patients Enrolled

Media Library

LY3361237 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05123586 — Phase 2
Lupus Research Study Groups: Placebo, LY3361237
Lupus Clinical Trial 2023: LY3361237 Highlights & Side Effects. Trial Name: NCT05123586 — Phase 2
LY3361237 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05123586 — Phase 2
Lupus Patient Testimony for trial: Trial Name: NCT05123586 — Phase 2
~24 spots leftby Oct 2025
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