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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05123586
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Czechia, Mexico, Poland, Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: LY3361237

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

Placebo Comparator: Placebo

Placebo administered SC and SOC given at matching intervals

Interventions

Drug: - LY3361237

Administered SC

Drug: - Placebo

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mesa, Arizona

Status

Not yet recruiting

Address

Arizona Arthritis & Rheumatology Associates, P. C.

Mesa, Arizona, 85210

Phoenix, Arizona

Status

Not yet recruiting

Address

Arizona Arthritis & Rheumatology Associates

Phoenix, Arizona, 85037

Sun City, Arizona

Status

Not yet recruiting

Address

Arizona Arthritis & Rheumatology Research - Sun City

Sun City, Arizona, 85351

Newport Huntington Med Grp, Huntington Beach, California

Status

Recruiting

Address

Newport Huntington Med Grp

Huntington Beach, California, 92648

Desert Medical Advances, Palm Desert, California

Status

Recruiting

Address

Desert Medical Advances

Palm Desert, California, 92260

Clearwater, Florida

Status

Recruiting

Address

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, 33765

Ezy Medical Research, Miami, Florida

Status

Not yet recruiting

Address

Ezy Medical Research

Miami, Florida, 33175

Clinical Research of West Florida, Tampa, Florida

Status

Recruiting

Address

Clinical Research of West Florida

Tampa, Florida, 33606

Atlanta Research Center for Rheumatology, Marietta, Georgia

Status

Not yet recruiting

Address

Atlanta Research Center for Rheumatology

Marietta, Georgia, 30060

Qualmedica Research, LLC, Evansville, Indiana

Status

Recruiting

Address

Qualmedica Research, LLC

Evansville, Indiana, 47715

Clinvest Research LLC, Springfield, Missouri

Status

Recruiting

Address

Clinvest Research LLC

Springfield, Missouri, 65807

SUNY Upstate Medical University, Syracuse, New York

Status

Not yet recruiting

Address

SUNY Upstate Medical University

Syracuse, New York, 13210

University of North Carolina, Hillsborough, North Carolina

Status

Not yet recruiting

Address

University of North Carolina

Hillsborough, North Carolina, 27278

Paramount Medical Research, Middleburg Heights, Ohio

Status

Recruiting

Address

Paramount Medical Research

Middleburg Heights, Ohio, 44130

Tekton Research, Inc., Austin, Texas

Status

Recruiting

Address

Tekton Research, Inc.

Austin, Texas, 78745

Rheumatology Center Of Houston, Houston, Texas

Status

Not yet recruiting

Address

Rheumatology Center Of Houston

Houston, Texas, 77004

Katy, Texas

Status

Recruiting

Address

Houston Rheumatology & Arthritis Specialists

Katy, Texas, 77494

International Sites

Clínica Privada Independencia, Munro, Buenos Aires, Argentina

Status

Recruiting

Address

Clínica Privada Independencia

Munro, Buenos Aires,

Zárate, Buenos Aires, Argentina

Status

Recruiting

Address

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, 2800

Caba, Ciudad Autónoma De Buenos Aire, Argentina

Status

Recruiting

Address

APRILLUS Asistencia E Investigacion de Arcis Salud

Caba, Ciudad Autónoma De Buenos Aire, 1406

SAN M. DE Tucuman, Tucumán, Argentina

Status

Recruiting

Address

Centro de Investigaciones Médicas Tucuman

SAN M. DE Tucuman, Tucumán, T4000AXL

DOM Centro de Reumatología, Ciudad Autónoma de Buenos Aire, Argentina

Status

Recruiting

Address

DOM Centro de Reumatología

Ciudad Autónoma de Buenos Aire, , C1111

CENUDIAB, Ciudad Autónoma de Buenos Aire, Argentina

Status

Recruiting

Address

CENUDIAB

Ciudad Autónoma de Buenos Aire, , C1440AAD

Revmatologie.s.r.o., Brno, Brno-město, Czechia

Status

Recruiting

Address

Revmatologie.s.r.o.

Brno, Brno-město, 63800

Artroscan, s.r.o., Ostrava, Moravskoslezský Kraj, Czechia

Status

Recruiting

Address

Artroscan, s.r.o.

Ostrava, Moravskoslezský Kraj, 722 00

Vseobecna fakultni nemocnice v Praze, Praha 2, Czechia

Status

Not yet recruiting

Address

Vseobecna fakultni nemocnice v Praze

Praha 2, , 12808

Centro Medico del Angel, Mexicali, Baja California, Mexico

Status

Recruiting

Address

Centro Medico del Angel

Mexicali, Baja California, 21100

CIMAB SA de CV, Torreon, Coahuila, Mexico

Status

Recruiting

Address

CIMAB SA de CV

Torreon, Coahuila, 27000

Mexico City, Distrito Federal, Mexico

Status

Not yet recruiting

Address

CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

Mexico City, Distrito Federal, 06700

Guadalajara, Jalisco, Mexico

Status

Not yet recruiting

Address

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Jalisco, 44650

Szpital Uniwersytecki Nr 2 w Bydgoszczy, Bydgoszcz, Kujawsko-pomorskie, Poland

Status

Recruiting

Address

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, Kujawsko-pomorskie, 85-168

Nowa Sol, Lubuskie, Poland

Status

Recruiting

Address

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sol, Lubuskie, 67-100

Nova Reuma Społka Partnerska, Bialystok, Podlaskie, Poland

Status

Recruiting

Address

Nova Reuma Społka Partnerska

Bialystok, Podlaskie, 15-707

Poznan, Wielkopolskie, Poland

Status

Recruiting

Address

Twoja Przychodnia Poznanskie Centrum Medyczne

Poznan, Wielkopolskie, 61-293

Centro Reumatologico Caguas, Caguas, Puerto Rico

Status

Not yet recruiting

Address

Centro Reumatologico Caguas

Caguas, , 00725

Latin Clinical Trial Center, San Juan, Puerto Rico

Status

Recruiting

Address

Latin Clinical Trial Center

San Juan, , 00909

Mindful Medical Research, San Juan, Puerto Rico

Status

Not yet recruiting

Address

Mindful Medical Research

San Juan, , 00918

GCM Medical Group, PSC - Hato Rey Site, San Juan, Puerto Rico

Status

Recruiting

Address

GCM Medical Group, PSC - Hato Rey Site

San Juan, , 917