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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05123586
Collaborator
(none)
90
Enrollment
47
Locations
2
Arms
25.3
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 7, 2022
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Apr 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3361237

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

Drug: LY3361237
Administered SC
Placebo Comparator: Placebo

Placebo administered SC and SOC given at matching intervals

Drug: Placebo
Administered SC

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission fo Arthritis and/or Rash [Week 24]

    Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and//or Rash

Secondary Outcome Measures

  1. Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response [Week 24]

    Percentage of Participants Who Achieve SLEDAI-4 Response

  2. Percentage of Participants who achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 response) [Week 24]

    Percentage of Participants who achieve SRI-4 response

  3. Pharmacokinetics (PK): Steady-state trough serum concentration of LY3361237 [Week 24]

    PK: Steady-state trough serum concentration of LY3361237

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona Arthritis & Rheumatology Associates, P. C. Mesa Arizona United States 85210
2 Arizona Arthritis & Rheumatology Associates Phoenix Arizona United States 85037
3 Arizona Arthritis & Rheumatology Research - Sun City Sun City Arizona United States 85351
4 Newport Huntington Med Grp Huntington Beach California United States 92648
5 Desert Medical Advances Palm Desert California United States 92260
6 Clinical Research of West Florida, Inc. (Clearwater) Clearwater Florida United States 33765
7 University of Florida College of Medicine Gainesville Florida United States 32610
8 Ezy Medical Research Miami Florida United States 33175
9 Clinical Research of West Florida Tampa Florida United States 33606
10 Atlanta Research Center for Rheumatology Marietta Georgia United States 30060
11 Qualmedica Research, LLC Evansville Indiana United States 47715
12 University of Iowa Iowa City Iowa United States 52242
13 Clinvest Research LLC Springfield Missouri United States 65807
14 Columbia University Medical Center New York New York United States 10032
15 SUNY Upstate Medical University Syracuse New York United States 13210
16 University of North Carolina Hillsborough North Carolina United States 27278
17 Paramount Medical Research Middleburg Heights Ohio United States 44130
18 Tekton Research, Inc. Austin Texas United States 78745
19 Rheumatology Center Of Houston Houston Texas United States 77004
20 Houston Rheumatology & Arthritis Specialists Katy Texas United States 77494
21 Clínica Privada Independencia Munro Buenos Aires Argentina
22 Instituto de Investigaciones Clinicas Zarate Zárate Buenos Aires Argentina 2800
23 APRILLUS Asistencia E Investigacion de Arcis Salud Caba Ciudad Autónoma De Buenos Aire Argentina 1406
24 Centro de Investigaciones Médicas Tucuman SAN M. DE Tucuman Tucumán Argentina T4000AXL
25 DOM Centro de Reumatología Ciudad Autónoma de Buenos Aire Argentina C1111
26 CENUDIAB Ciudad Autónoma de Buenos Aire Argentina C1440AAD
27 Revmatologie.s.r.o. Brno Brno-město Czechia 63800
28 Artroscan, s.r.o. Ostrava Moravskoslezský Kraj Czechia 722 00
29 Vseobecna fakultni nemocnice v Praze Praha 2 Czechia 12808
30 Nouvel Hôpital Civil (NHC) Strasbourg Alsace France 67091
31 Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan Toulouse Haute-Garo France 31059
32 Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes France 44093
33 Centro Medico del Angel Mexicali Baja California Mexico 21100
34 CIMAB SA de CV Torreon Coahuila Mexico 27000
35 CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas Mexico City Distrito Federal Mexico 06700
36 Clinica de Investigacion en Reumatologia y Obesidad S. C. Guadalajara Jalisco Mexico 44650
37 Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V. Zapopan Jalisco Mexico 45070
38 Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy Bydgoszcz Kujawsko-pomorskie Poland 85-168
39 Twoja Przychodnia Centrum Medyczne Nowa Sol Nowa Sol, Lubuskie Poland 67-100
40 Nova Reuma Społka Partnerska Bialystok Podlaskie Poland 15-707
41 Twoja Przychodnia Poznanskie Centrum Medyczne Poznań Wielkopolskie Poland 61-293
42 Centro Reumatologico Caguas Caguas Puerto Rico 00725
43 Latin Clinical Trial Center San Juan Puerto Rico 00909
44 Mindful Medical Research San Juan Puerto Rico 00918
45 GCM Medical Group, PSC - Hato Rey Site San Juan Puerto Rico 917
46 Chang Gung Medical Foundation-Linkou Branch Taoyuan City Taoyuan Taiwan 333
47 Taipei Veterans General Hospital Taipei City Taiwan 11217

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05123586
Other Study ID Numbers:
  • 18248
  • J1V-MC-BT01
  • 2021-001406-30
First Posted:
Nov 17, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Autoimmune Disease
BTLA B and T Lymphocyte attenuator
Immune checkpoint
Inhibitory checkpoint agonist antibody
Lupus
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Aug 18, 2022