NCT05123586TerminatedPhase 2
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Eli Lilly and Company
- Enrollment
- 85
- Locations
- 47
- Primary Endpoint
- Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LY3361237
Experimental
Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC)
Intervention: LY3361237 (Drug)
Placebo
Placebo Comparator
Placebo administered SC and SOC given at matching intervals
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash
Time Frame: Week 24
Remission of arthritis and/or rash is defined by the following: if only arthritis is present at baseline, then the primary endpoint is met if arthritis is absent at Week 24; if only rash is present at baseline, then the primary endpoint is met if rash is absent at Week 24; if both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Secondary Outcomes
- Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response(Week 24)
- Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)(Week 24)
- Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24(Week 24)
Investigators
Study Sites (47)
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