A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
NCT ID: NCT05123586
Last Updated: 2025-01-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
85 participants
INTERVENTIONAL
2022-03-07
2023-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3361237
Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC)
LY3361237
Administered SC
Placebo
Placebo administered SC and SOC given at matching intervals
Placebo
Administered SC
Interventions
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LY3361237
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Associates
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Research - Sun City
Sun City, Arizona, United States
Newport Huntington Med Grp
Huntington Beach, California, United States
Desert Medical Advances
Rancho Mirage, California, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States
Ezy Medical Research
Miami, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Atlanta Research Center for Rheumatology
Marietta, Georgia, United States
Qualmedica Research, LLC
Evansville, Indiana, United States
Tekton Research, Inc
Wichita, Kansas, United States
Clinvest Research LLC
Springfield, Missouri, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of North Carolina
Hillsborough, North Carolina, United States
Paramount Medical Research
Middleburg Heights, Ohio, United States
Tekton Research, Inc.
Moore, Oklahoma, United States
Tekton Research, Inc
Austin, Texas, United States
Rheumatology Center Of Houston
Houston, Texas, United States
Houston Rheumatology & Arthritis Specialists
Katy, Texas, United States
Clínica Privada Independencia
Munro, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, Argentina
APRILLUS Asistencia E Investigacion
CABA, Ciudad Autónoma de Buenos Aire, Argentina
Instituto de Investigaciones Clinicas Zarate
Zárate, Santa Fe Province, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, Argentina
APRILLUS Asistencia E Investigacion
Ciudad Autónoma de Buenos Aire, , Argentina
DOM Centro de Reumatología
Ciudad Autónoma de Buenos Aire, , Argentina
CENUDIAB
Ciudad Autónoma de Buenos Aire, , Argentina
Revmatologie.s.r.o.
Brno, Brno-město, Czechia
Artroscan, s.r.o.
Ostrava, Moravskoslezský kraj, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Nouvel Hôpital Civil (NHC)
Strasbourg, Alsace, France
Centre Hospitalier Regional D'Orleans
Orléans, Centre-Val de Loire, France
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
Toulouse, Haute-Garo, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, , France
CIMAB SA de CV
Torreón, Coahuila, Mexico
Centro Medico del Angel
Mexicali, Estado de Baja California, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, Mexico
Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco, Mexico
Twoja Przychodnia Poznanskie Centrum Medyczne
Poznan, Greater Poland Voivodeship, Poland
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, Poland
Nova Reuma Społka Partnerska
Bialystok, Podlaskie Voivodeship, Poland
Centro Reumatologico Caguas
Caguas, PR, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, PR, Puerto Rico
Latin Clinical Trial Center
San Juan, , Puerto Rico
Mindful Medical Research
San Juan, , Puerto Rico
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Tri-Service General Hospital
Taipei City, Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taoyuan, Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol: Protocol ISA J1V-MC-BT01 (a)
Document Type: Study Protocol: Master Protocol J1V-MC-IMMA
Document Type: Statistical Analysis Plan: Statistical Analysis Plan J1V-MC-BT01 Version 3
Document Type: Statistical Analysis Plan: Statistical Analysis Plan J1V-MC-IMMA Version 2
Related Links
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A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
Other Identifiers
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J1V-MC-BT01
Identifier Type: OTHER
Identifier Source: secondary_id
2021-001406-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18248
Identifier Type: -
Identifier Source: org_study_id
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