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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

Study Summary

This trial will study a potential new treatment for lupus. It will last up to 34 weeks and involve up to 15 visits.

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.Check my eligibility
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.See study design
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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission fo Arthritis and/or Rash
Secondary outcome measures
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
2022
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,844 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,167 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards are associated with administering LY3361237 to patients?

"The safety of LY3361237 has been estimated to be a 2 out of 3 on the Power scale, as this is currently in Phase 2 trials which lacks efficacy data but does indicate some degree of safety."

Answered by AI

Could you provide information about the various centers in town that are conducting this medical trial?

"Currently, 23 clinical sites are opening recruitment for this trial. Patients can find a centre near them in Houston, Katy, or Huntington Beach as well as other locations. It is suggested to select the site nearest you so that commuting demands may be minimized if one decides to partake in the study."

Answered by AI

Could I be a suitable candidate for this trial?

"This experiment is looking to enrol 90 people with Libman-Sacks disease, aged between 18 and 65. Moreover, all applicants must comply with the European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) 2019 classification criteria for SLE which requires a score of 10 points or more, as well as present a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 at screening day 1 and this same index's score needs to be at least 4 when excluding laboratory values on randomization Day 2."

Answered by AI

Is the eligibility criteria for this research study limited to those under 60 years of age?

"Enrollment in this trial requires that patients are above the legal age of consent and below 65 years old."

Answered by AI

How many volunteers are participating in this medical trial?

"The sponsor of this study, Eli Lilly and Company, are seeking 90 participants that adhere to the set inclusions criteria. The trial will be conducted at Houston Rheumatology & Arthritis Specialists in Katy, California and Newport Huntington Med Grp in Huntington Beach, Arizona."

Answered by AI

Is this trial taking on new participants at the moment?

"Affirmative. Per the data hosted on clinicaltrials.gov, this medical trial is currently in its recruitment phase. This study was initially posted on March 7th 2022 and has been recently modified as of November 22nd 2022. Ninety patients need to be enrolled among a total of 23 sites."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Rheumatology Center Of Houston
Tekton Research, Inc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

To find a solution to my problem. I was diagnosed a little over a year ago and have had an extremely difficult time with flare-ups. I was unable to take the anti-malaria medication as it made me vomit. I would really like to help others that are suffering as much, if not more, than me to find a medication that really helps people with this horrible disease live a normal life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
2022. "A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123586.
~28 spots leftby Apr 2025
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