Clinical trial NCT05123586: A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Autoimmune Disease
BTLA B and T Lymphocyte attenuator
Immune checkpoint
Inhibitory checkpoint agonist antibody
Lupus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response
timeFrame: Week 24
measure: Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)
timeFrame: Week 24
measure: Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P. C.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates
state: Arizona
city: Sun City
country: United States
facility: Arizona Arthritis & Rheumatology Research - Sun City
state: Arizona
city: Huntington Beach
country: United States
facility: Newport Huntington Med Grp
state: California
city: Rancho Mirage
country: United States
facility: Desert Medical Advances
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology
state: Georgia
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Wichita
country: United States
facility: Tekton Research, Inc
state: Kansas
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Hillsborough
country: United States
facility: University of North Carolina
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research
state: Ohio
city: Moore
country: United States
facility: Tekton Research, Inc.
state: Oklahoma
city: Austin
country: United States
facility: Tekton Research, Inc
state: Texas
city: Houston
country: United States
facility: Rheumatology Center Of Houston
state: Texas
city: Katy
country: United States
facility: Houston Rheumatology & Arthritis Specialists
state: Texas
city: Munro
country: Argentina
facility: Clínica Privada Independencia
state: Buenos Aires
city: Zárate
country: Argentina
facility: Instituto de Investigaciones Clinicas Zarate
state: Buenos Aires
city: Caba
country: Argentina
facility: APRILLUS Asistencia E Investigacion
state: Ciudad Autónoma De Buenos Aire
city: Zárate
country: Argentina
facility: Instituto de Investigaciones Clinicas Zarate
state: Santa Fe
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: APRILLUS Asistencia E Investigacion
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: DOM Centro de Reumatología
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: CENUDIAB
city: Brno
country: Czechia
facility: Revmatologie.s.r.o.
state: Brno-město
city: Ostrava
country: Czechia
facility: Artroscan, s.r.o.
state: Moravskoslezský Kraj
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil (NHC)
state: Alsace
city: Orléans
country: France
facility: Centre Hospitalier Regional D'Orleans
state: Centre
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
state: Haute-Garo
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
city: Mexicali
country: Mexico
facility: Centro Medico del Angel
state: Baja California
city: Torreon
country: Mexico
facility: CIMAB SA de CV
state: Coahuila
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.
state: Jalisco
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
state: Kujawsko-pomorskie
city: Nowa Sol,
country: Poland
facility: Twoja Przychodnia Centrum Medyczne Nowa Sol
state: Lubuskie
city: Bialystok
country: Poland
facility: Nova Reuma Społka Partnerska
state: Podlaskie
city: Poznań
country: Poland
facility: Twoja Przychodnia Poznanskie Centrum Medyczne
state: Wielkopolskie
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico Caguas
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
state: Taoyuan
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: