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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05123586
Recruitment Status : Completed
First Posted : November 17, 2021
Last Update Posted : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: LY3361237 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 7, 2022
Actual Primary Completion Date : December 29, 2023
Actual Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3361237
Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC)
 Drug: LY3361237
Administered SC
Placebo Comparator: Placebo
Placebo administered SC and SOC given at matching intervals
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission fo Arthritis and/or Rash [ Time Frame: Week 24 ]
    Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and//or Rash


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response [ Time Frame: Week 24 ]
    Percentage of Participants Who Achieve SLEDAI-4 Response

  2. Percentage of Participants who achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 response) [ Time Frame: Week 24 ]
    Percentage of Participants who achieve SRI-4 response

  3. Pharmacokinetics (PK): Steady-state trough serum concentration of LY3361237 [ Time Frame: Week 24 ]
    PK: Steady-state trough serum concentration of LY3361237


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05123586


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05123586    
Other Study ID Numbers: 18248
J1V-MC-BT01 ( Other Identifier: Eli Lilly and Company )
2021-001406-30 ( EudraCT Number )
First Posted: November 17, 2021    Key Record Dates
Last Update Posted: March 4, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Autoimmune Disease
BTLA B and T Lymphocyte attenuator
Immune checkpoint
Inhibitory checkpoint agonist antibody
Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases