A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus
- Registration Number
- NCT05123586
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 85
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3361237 LY3361237 Participants are administered LY3361237 subcutaneously (SC) and standard of care (SOC) Placebo Placebo Placebo administered SC and SOC given at matching intervals
- Primary Outcome Measures
Name Time Method Percentage of Participants With Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash Week 24 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve Systemic Lupus Erythematosus Disease Activity Index-4 (SLEDAI-4) Response Week 24 Percentage of participants who achieved SLEDAI-4 response was assessed. A SLEDAI-4 response is defined as a ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).
Percentage of Participants Who Achieve Systemic Lupus Erythematosus Responder Index-4 (SRI-4 Response) Week 24 Percentage of participants who achieved SRI-4 response was assessed. SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Pharmacokinetics (PK): Steady-state Trough Serum Concentration of LY3361237 at Week 24 Week 24 PK: Steady-state trough serum concentration of LY3361237 at Week 24 was assessed.
Trial Locations
- Locations (47)
Atlanta Research Center for Rheumatology
🇺🇸Marietta, Georgia, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Ezy Medical Research
🇺🇸Miami, Florida, United States
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Newport Huntington Med Grp
🇺🇸Huntington Beach, California, United States
Desert Medical Advances
🇺🇸Rancho Mirage, California, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
Qualmedica Research, LLC
🇺🇸Evansville, Indiana, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
University of North Carolina
🇺🇸Hillsborough, North Carolina, United States
Paramount Medical Research
🇺🇸Middleburg Heights, Ohio, United States
Tekton Research, Inc.
🇺🇸Moore, Oklahoma, United States
Rheumatology Center Of Houston
🇺🇸Houston, Texas, United States
Houston Rheumatology & Arthritis Specialists
🇺🇸Katy, Texas, United States
Clínica Privada Independencia
🇦🇷Munro, Buenos Aires, Argentina
APRILLUS Asistencia E Investigacion
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina
DOM Centro de Reumatología
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
CENUDIAB
🇦🇷Ciudad Autónoma de Buenos Aire, Argentina
Artroscan, s.r.o.
🇨🇿Ostrava, Moravskoslezský Kraj, Czechia
Revmatologie.s.r.o.
🇨🇿Brno, Brno-město, Czechia
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
🇫🇷Nantes, France
Nouvel Hôpital Civil (NHC)
🇫🇷Strasbourg, Alsace, France
Centre Hospitalier Regional D'Orleans
🇫🇷Orléans, Centre, France
Centro Medico del Angel
🇲🇽Mexicali, Baja California, Mexico
CIMAB SA de CV
🇲🇽Torreon, Coahuila, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
🇲🇽Guadalajara, Jalisco, Mexico
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.
🇲🇽Zapopan, Jalisco, Mexico
Mindful Medical Research
🇵🇷San Juan, Puerto Rico
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
Tri-Service General Hospital
🇨🇳Taipei City, Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan City, Taoyuan, Taiwan
Instituto de Investigaciones Clinicas Zarate
🇦🇷Zárate, Santa Fe, Argentina
Arizona Arthritis & Rheumatology Associates, P. C.
🇺🇸Mesa, Arizona, United States
Nova Reuma Społka Partnerska
🇵🇱Bialystok, Podlaskie, Poland
Arizona Arthritis & Rheumatology Research - Sun City
🇺🇸Sun City, Arizona, United States
Twoja Przychodnia Centrum Medyczne Nowa Sol
🇵🇱Nowa Sol,, Lubuskie, Poland
Twoja Przychodnia Poznanskie Centrum Medyczne
🇵🇱Poznań, Wielkopolskie, Poland
Centro Reumatologico Caguas
🇵🇷Caguas, Puerto Rico
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
🇫🇷Toulouse, Haute-Garo, France
Arizona Arthritis & Rheumatology Associates
🇺🇸Phoenix, Arizona, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
Tekton Research, Inc
🇺🇸Austin, Texas, United States