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

NCT05123586 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 18248J1V-MC-BT012021-001406-30
• Study Type: interventional
• Target: 85
• Locations: 8 countries
• Sites: 50

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Autoimmune Disease; BTLA B and T Lymphocyte attenuator; Immune checkpoint; Inhibitory checkpoint agonist antibody; Lupus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response

  Week 24

• Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response)

  Week 24

• Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24

  Week 24

Study Arms (2)

LY3361237

EXPERIMENTAL

Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC)

Drug: LY3361237

Placebo

PLACEBO COMPARATOR

Placebo administered SC and SOC given at matching intervals

Drug: Placebo

Interventions

LY3361237 DRUG

Administered SC

LY3361237

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (50)

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, 85210, United States

Location

Arizona Arthritis & Rheumatology Associates

Phoenix, Arizona, 85037, United States

Location

Arizona Arthritis & Rheumatology Research - Sun City

Sun City, Arizona, 85351, United States

Location

Newport Huntington Med Grp

Huntington Beach, California, 92648, United States

Location

Desert Medical Advances

Rancho Mirage, California, 92270, United States

Location

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, 33765, United States

Location

Ezy Medical Research

Miami, Florida, 33175, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33606, United States

Location

Atlanta Research Center for Rheumatology

Marietta, Georgia, 30060, United States

Location

Qualmedica Research, LLC

Evansville, Indiana, 47715, United States

Location

Tekton Research, Inc

Wichita, Kansas, 67218, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65807, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of North Carolina

Hillsborough, North Carolina, 27278, United States

Location

Paramount Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

Tekton Research, Inc.

Moore, Oklahoma, 73160, United States

Location

Tekton Research, Inc

Austin, Texas, 78745, United States

Location

Rheumatology Center Of Houston

Houston, Texas, 77004, United States

Location

Houston Rheumatology & Arthritis Specialists

Katy, Texas, 77494, United States

Location

Clínica Privada Independencia

Munro, Buenos Aires, Argentina

Location

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, B2800DGH, Argentina

Location

APRILLUS Asistencia E Investigacion

CABA, Ciudad Autónoma de Buenos Aire, 1046, Argentina

Location

Instituto de Investigaciones Clinicas Zarate

Zárate, Santa Fe Province, 2800, Argentina

Location

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina

Location

APRILLUS Asistencia E Investigacion

Ciudad Autónoma de Buenos Aire, 1406, Argentina

Location

DOM Centro de Reumatología

Ciudad Autónoma de Buenos Aire, C1111, Argentina

Location

CENUDIAB

Ciudad Autónoma de Buenos Aire, C1440AAD, Argentina

Location

Revmatologie.s.r.o.

Brno, Brno-město, 63800, Czechia

Location

Artroscan, s.r.o.

Ostrava, Moravskoslezský kraj, 722 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

Location

Nouvel Hôpital Civil (NHC)

Strasbourg, Alsace, 67091, France

Location

Centre Hospitalier Regional D'Orleans

Orléans, Centre-Val de Loire, 45067, France

Location

Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

Toulouse, Haute-Garo, 31059, France

Location

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, 44093, France

Location

CIMAB SA de CV

Torreón, Coahuila, 27000, Mexico

Location

Centro Medico del Angel

Mexicali, Estado de Baja California, 21100, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Jalisco, 44650, Mexico

Location

Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.

Zapopan, Jalisco, 45070, Mexico

Location

Twoja Przychodnia Poznanskie Centrum Medyczne

Poznan, Greater Poland Voivodeship, 61-293, Poland

Location

Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

Nova Reuma Społka Partnerska

Bialystok, Podlaskie Voivodeship, 15-707, Poland

Location

Centro Reumatologico Caguas

Caguas, PR, 00725, Puerto Rico

Location

GCM Medical Group, PSC - Hato Rey Site

San Juan, PR, 917, Puerto Rico

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

Mindful Medical Research

San Juan, 00918, Puerto Rico

Location

Chang Gung Memorial Hospital at Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

Tri-Service General Hospital

Taipei City, Taipei, 114, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taoyuan, 333, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 17, 2021
• Study Start: March 7, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.

Locations

US (19); ME (4); PR (4); AR (8); TW (4); CZ (3); FR (4); PL (4)