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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05123586
• Other study ID #: 18248
• Secondary ID: J1V-MC-BT012021-
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

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

External Links

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