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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05123586
Other study ID # 18248
Secondary ID J1V-MC-BT012021-
Status Completed
Phase Phase 2
First received
Last updated
Start date March 7, 2022
Est. completion date December 29, 2023

Study information

Verified date March 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date December 29, 2023
Est. primary completion date December 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Drug:
LY3361237
Administered SC
Placebo
Administered SC

Locations

Country Name City State
Argentina APRILLUS Asistencia E Investigacion Caba Ciudad Autónoma De Buenos Aire
Argentina APRILLUS Asistencia E Investigacion Ciudad Autónoma de Buenos Aire
Argentina CENUDIAB Ciudad Autónoma de Buenos Aire
Argentina DOM Centro de Reumatología Ciudad Autónoma de Buenos Aire
Argentina Clínica Privada Independencia Munro Buenos Aires
Argentina Centro de Investigaciones Médicas Tucuman SAN M. DE Tucuman Tucumán
Argentina Instituto de Investigaciones Clinicas Zarate Zárate Santa Fe
Argentina Instituto de Investigaciones Clinicas Zarate Zárate Buenos Aires
Czechia Revmatologie.s.r.o. Brno Brno-mesto
Czechia Artroscan, s.r.o. Ostrava Moravskoslezský Kraj
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
France Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes
France Centre Hospitalier Regional D'Orleans Orléans Centre
France Nouvel Hôpital Civil (NHC) Strasbourg Alsace
France Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan Toulouse Haute-Garo
Mexico Clinica de Investigacion en Reumatologia y Obesidad S. C. Guadalajara Jalisco
Mexico Centro Medico del Angel Mexicali Baja California
Mexico CIMAB SA de CV Torreon Coahuila
Mexico Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V. Zapopan Jalisco
Poland Nova Reuma Spolka Partnerska Bialystok Podlaskie
Poland Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy Bydgoszcz Kujawsko-pomorskie
Poland Twoja Przychodnia Centrum Medyczne Nowa Sol Nowa Sol, Lubuskie
Poland Twoja Przychodnia Poznanskie Centrum Medyczne Poznan Wielkopolskie
Puerto Rico Centro Reumatologico Caguas Caguas
Puerto Rico GCM Medical Group, PSC - Hato Rey Site San Juan
Puerto Rico Latin Clinical Trial Center San Juan
Puerto Rico Mindful Medical Research San Juan
Taiwan Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Niao Sung Dist Kaohsiung
Taiwan Taipei Veterans General Hospital Taipei City
Taiwan Tri-Service General Hospital Taipei City Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan City Taoyuan
United States Tekton Research, Inc Austin Texas
United States Clinical Research of West Florida, Inc. (Clearwater) Clearwater Florida
United States Qualmedica Research, LLC Evansville Indiana
United States University of North Carolina Hillsborough North Carolina
United States Rheumatology Center Of Houston Houston Texas
United States Newport Huntington Med Grp Huntington Beach California
United States Houston Rheumatology & Arthritis Specialists Katy Texas
United States Atlanta Research Center for Rheumatology Marietta Georgia
United States Arizona Arthritis & Rheumatology Associates, P. C. Mesa Arizona
United States Ezy Medical Research Miami Florida
United States Paramount Medical Research Middleburg Heights Ohio
United States Tekton Research, Inc. Moore Oklahoma
United States Arizona Arthritis & Rheumatology Associates Phoenix Arizona
United States Desert Medical Advances Rancho Mirage California
United States Clinvest Research LLC Springfield Missouri
United States Arizona Arthritis & Rheumatology Research - Sun City Sun City Arizona
United States SUNY Upstate Medical University Syracuse New York
United States Clinical Research of West Florida Tampa Florida
United States Tekton Research, Inc Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Czechia,  France,  Mexico,  Poland,  Puerto Rico,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Percentage of Participants who achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 response) Percentage of Participants who achieve SRI-4 response Week 24
Secondary Pharmacokinetics (PK): Steady-state trough serum concentration of LY3361237 PK: Steady-state trough serum concentration of LY3361237 Week 24
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