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

Lilly

Status and phase: Terminated; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Placebo; Drug: LY3361237

Study type: Interventional

Funder types: Industry

Identifiers

NCT05123586

J1V-MC-BT01 (Other Identifier)

18248

2021-001406-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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85 participants in 2 patient groups, including a placebo group

LY3361237

Experimental group

Description:

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

Treatment:

Drug: LY3361237

Placebo

Placebo Comparator group

Description:

Placebo administered SC and SOC given at matching intervals

Treatment:

Drug: Placebo