A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus

Study Purpose

The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Are diagnosed with SLE at least 24 weeks before Day 1 of study.

- Have documentation of having a score of 10 or more points on the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.

- Have a SLEDAI-2K score ≥6 at screening (Day 1) and clinical Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥4 (not including any items related to laboratory values) at randomization (Day 2) - Must be receiving at least 1 background standard-of-care medication for SLE.

Exclusion Criteria:

- Participants are excluded if they have received any of the following medications or therapies within the indicated timeframe prior to the randomization visit (Day 2).

- 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 received parenteral corticosteroids within 12 weeks before starting study treatment or are expected to require parenteral corticosteroids during the study.

- Have a current or recent acute, active infection.

- Have had a serious, chronic, recurring conditions of herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis) - Have human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV), hepatitis C infection (HCV), active tuberculosis (TB) - Have active fibromyalgia or active occurrence of an inflammatory condition that, in the investigator's opinion, would make it difficult to appropriately assess SLE activity for the purposes of this study.

- Have experienced a cardiac event within 24 weeks to 12 months prior to screening.

- Have a history of clinically significant or uncontrolled illness that in the opinion of the investigator could put the participant at risk to participate in the study.

- Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.

- Are pregnant or are intending to become pregnant or to breastfeed at any time in the study

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05123586
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Eli Lilly and Company
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation	Eli Lilly and Company
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Czechia, France, Mexico, Poland, Puerto Rico, Taiwan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: LY3361237

Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC)

Placebo Comparator: Placebo

Placebo administered SC and SOC given at matching intervals

Interventions

Drug: - LY3361237

Administered SC

Drug: - Placebo

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mesa, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, 85210

Site Contact

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