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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT05123586

Run by

Eli Lilly and Company

People needed

85

Starts

2022-03-07

Expected to finish

2023-12-29

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Arthritis & Rheumatology Associates, P. C. — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Associates — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Research - Sun City — Sun City, Arizona, United States
• Newport Huntington Med Grp — Huntington Beach, California, United States
• Desert Medical Advances — Rancho Mirage, California, United States
• Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
• Ezy Medical Research — Miami, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Atlanta Research Center for Rheumatology — Marietta, Georgia, United States
• Qualmedica Research, LLC — Evansville, Indiana, United States
• Tekton Research, Inc — Wichita, Kansas, United States
• Clinvest Research LLC — Springfield, Missouri, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• University of North Carolina — Hillsborough, North Carolina, United States
• Paramount Medical Research — Middleburg Heights, Ohio, United States
• Tekton Research, Inc. — Moore, Oklahoma, United States
• Tekton Research, Inc — Austin, Texas, United States
• Rheumatology Center Of Houston — Houston, Texas, United States
• Houston Rheumatology & Arthritis Specialists — Katy, Texas, United States
• Clínica Privada Independencia — Munro, Buenos Aires, Argentina
• Instituto de Investigaciones Clinicas Zarate — Zárate, Buenos Aires, Argentina
• APRILLUS Asistencia E Investigacion — CABA, Ciudad Autónoma de Buenos Aire, Argentina
• Instituto de Investigaciones Clinicas Zarate — Zárate, Santa Fe Province, Argentina
• Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman, Tucumán Province, Argentina
• APRILLUS Asistencia E Investigacion — Ciudad Autónoma de Buenos Aire, Argentina

Full record on ClinicalTrials.gov

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