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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Two-Arm, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LY3361237 as a Treatment for Adults With At Least Moderately Active Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: LY3361237
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3361237<br>Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC) | Drug: LY3361237<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Placebo administered SC and SOC given at matching intervals | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission fo Arthritis and/or Rash | Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and//or Rash | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response | Percentage of Participants Who Achieve SLEDAI-4 Response | Week 24 | 
| Percentage of Participants who achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 response) | Percentage of Participants who achieve SRI-4 response | Week 24 | 
| Pharmacokinetics (PK): Steady-state trough serum concentration of LY3361237 | PK: Steady-state trough serum concentration of LY3361237 | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BTLA B and T Lymphocyte attenuator, Immune checkpoint, Inhibitory checkpoint agonist antibody, Lupus, Autoimmune Disease