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

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

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 Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Drug: LY3361237

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autónoma de Buenos Aire, Argentina, C1440AAD
    • CENUDIAB
  • Ciudad Autónoma de Buenos Aire, Argentina, 1406
    • APRILLUS Asistencia e Investigacion
  • Ciudad Autónoma de Buenos Aire, Argentina, C1111
    • DOM Centro de Reumatología
  • Buenos Aires
    • Munro, Buenos Aires, Argentina
      • Clinica Privada Independencia
    • Zárate, Buenos Aires, Argentina, B2800DGH
      • Instituto de Investigaciones Clínicas Zarate
  • Ciudad Autónoma De Buenos Aire
    • Caba, Ciudad Autónoma De Buenos Aire, Argentina, 1046
      • APRILLUS Asistencia e Investigacion
  • Santa Fe
    • Zárate, Santa Fe, Argentina, 2800
      • Instituto de Investigaciones Clínicas Zarate
  • Tucumán
    • SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
      • Centro de Investigaciones Medicas Tucuman
• Czechia
  • Praha 2, Czechia, 12808
    • Vseobecna fakultni nemocnice v Praze
  • Brno-město
    • Brno, Brno-město, Czechia, 63800
      • Revmatologie.s.r.o.
  • Moravskoslezský Kraj
    • Ostrava, Moravskoslezský Kraj, Czechia, 722 00
      • Artroscan, s.r.o.
• France
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
  • Alsace
    • Strasbourg, Alsace, France, 67091
      • Nouvel Hôpital Civil (NHC)
  • Centre
    • Orléans, Centre, France, 45067
      • Centre Hospitalier Régional D'orléans
  • Haute-Garo
    • Toulouse, Haute-Garo, France, 31059
      • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
• Mexico
  • Baja California
    • Mexicali, Baja California, Mexico, 21100
      • Centro Medico del Angel
  • Coahuila
    • Torreon, Coahuila, Mexico, 27000
      • CIMAB SA de CV
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Clinica de Investigacion en Reumatologia y Obesidad S. C.
    • Zapopan, Jalisco, Mexico, 45070
      • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
      • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
  • Lubuskie
    • Nowa Sol,, Lubuskie, Poland, 67-100
      • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-707
      • Nova Reuma Społka Partnerska
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 61-293
      • Twoja Przychodnia Poznanskie Centrum Medyczne
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Centro Reumatologico Caguas
  • San Juan, Puerto Rico, 00918
    • Mindful Medical Research
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center
  • San Juan, Puerto Rico, 917
    • GCM Medical Group, PSC - Hato Rey Site
• Taiwan
  • Taipei City, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Chang Gung Memorial Hospital at Kaohsiung
  • Taipei
    • Taipei City, Taipei, Taiwan, 114
      • Tri-Service General Hospital
  • Taoyuan
    • Taoyuan City, Taoyuan, Taiwan, 333
      • Chang Gung Medical Foundation-Linkou Branch
• United States
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Arizona Arthritis & Rheumatology Associates, P. C.
    • Phoenix, Arizona, United States, 85037
      • Arizona Arthritis & Rheumatology Associates
    • Sun City, Arizona, United States, 85351
      • Arizona Arthritis & Rheumatology Research - Sun City
  • California
    • Huntington Beach, California, United States, 92648
      • Newport Huntington Med Grp
    • Rancho Mirage, California, United States, 92270
      • Desert Medical Advances
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc. (Clearwater)
    • Miami, Florida, United States, 33175
      • Ezy Medical Research
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Atlanta Research Center for Rheumatology
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC
  • Kansas
    • Wichita, Kansas, United States, 67218
      • Tekton Research, Inc
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • New York
    • Syracuse, New York, United States, 13210
      • Suny Upstate Medical University
  • North Carolina
    • Hillsborough, North Carolina, United States, 27278
      • University of North Carolina
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research
  • Oklahoma
    • Moore, Oklahoma, United States, 73160
      • Tekton Research, Inc.
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc
    • Houston, Texas, United States, 77004
      • Rheumatology Center Of Houston
    • Katy, Texas, United States, 77494
      • Houston Rheumatology & Arthritis Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash	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.	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 achieved SLEDAI-4 response was assessed. A SLEDAI-4 response is defined as a ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).	Week 24
Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)	Percentage of participants who achieved SRI-4 response was assessed. SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.	Week 24
Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24	PK: Steady-state trough serum concentration of LY3361237 at Week 24 was assessed.	Week 24

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Lupus; Immune checkpoint; Autoimmune Disease; BTLA B and T Lymphocyte attenuator; Inhibitory checkpoint agonist antibody
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 18248; J1V-MC-BT01 (Other Identifier: Eli Lilly and Company); 2021-001406-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No