A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
- Conditions
- Rheumatoid ArthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT05516758
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 491
-
Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
-
Have moderately-to-severely active RA, at screening and baseline, defined by the presence of
- ≥6 swollen joints based on 66 joint count, and
- ≥6 tender joints based on 68 joint count.
-
Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.
-
Have Class IV RA according to ACR revised criteria.
-
Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
-
poorly controlled diabetes or hypertension
-
chronic kidney disease stage IIIb, IV, or V
-
symptomatic heart failure according to New York Heart Association Class II, III, or IV
-
myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization
-
severe chronic pulmonary disease, for example, requiring oxygen therapy
-
major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,
- systemic lupus erythematosus
- psoriatic arthritis
- axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis
- reactive arthritis
- gout
- scleroderma
- polymyositis
- dermatomyositis
- active fibromyalgia, or
- multiple sclerosis
-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peresolimab Dose 1 Peresolimab Participants will be given peresolimab by subcutaneous injection. Peresolimab Dose 2 Peresolimab Participants will be given peresolimab by subcutaneous injection. Placebo Placebo Participants will be give placebo by subcutaneous injection. Peresolimab Dose 3 Peresolimab Participants will be given peresolimab by subcutaneous injection.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving American College of Rheumatology (ACR)20 Baseline to Week 12 ACR20 - 20% improvement in the ACR core set values
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI) Week 12 Percentage of Participants Achieving ACR50 or ACR70 Baseline to Week 12 ACR50 - 50% improvement in the ACR core set values or ACR70 - 70% improvement in the ACR core set values
Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) Week 12 Change from Baseline in Patient-Reported ACR Core Set Values in Patient's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI) Baseline, Week 12 Change from Baseline in CDAI Baseline, Week 12 Change from Baseline in DAS28-hsCRP Baseline, Week 12 Pharmacokinetics (PK): Observed Trough Drug Concentration Baseline to Week 12
Trial Locations
- Locations (127)
St Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Mesa, Arizona, United States
Wolverine Clinical Trials
🇺🇸Tustin, California, United States
Great Lakes Clinical Trials - Ravenswood
🇺🇸Chicago, Illinois, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
Laila A Hassan, MD, PA
🇺🇸Houston, Texas, United States
General Hospital of Athens Laiko
🇬🇷Athens, Attikí, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, Krítí, Greece
University Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Évros, Greece
Desert Medical Advances
🇺🇸Rancho Mirage, California, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Piedmont Arthritis Clinic
🇺🇸Greenville, South Carolina, United States
Medvin Clinical Research - Su
🇺🇸Whittier, California, United States
Albuquerque Center for Rheumatology
🇺🇸Albuquerque, New Mexico, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Tekton Research, Inc
🇺🇸Austin, Texas, United States
Dan La, MD Inc
🇺🇸Tujunga, California, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Paramount Medical Research & Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
Centro Reumatologico Caguas
🇵🇷Caguas, Puerto Rico
Nzoz Bif-Med
🇵🇱Bytom, Śląskie, Poland
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
🇨🇦Quebec, Canada
Accurate Clinical Management
🇺🇸Baytown, Texas, United States
Centro de Investigaciones Reumatológicas
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
University of Occupational and Enviromental Health
🇯🇵Kitakyushu, Fukuoka, Japan
Fundación Respirar
🇦🇷Buenos Aires, Argentina
Afflilated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Tongji Hospital Tongji Medical,Science & Technology
🇨🇳Wuhan, Hubei, China
Revita Clinic
🇭🇺Budapest, Pest, Hungary
Cape Fear Arthritis Care
🇺🇸Leland, North Carolina, United States
Organizacion Medica de Investigacion
🇦🇷Caba, Buenos Aires, Argentina
Centro Privado de Medicina Familiar / Mindout Research
🇦🇷Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Mindful Medical Research
🇵🇷San Juan, Puerto Rico
Aggarwal and Associates Limited
🇨🇦Brampton, Ontario, Canada
Clinstile, S.A. de C.V.
🇲🇽Mexico, Distrito Federal, Mexico
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
ShenZhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Chubu Rosai Hospital
🇯🇵Nagoya, Aichi, Japan
Qualiclinic
🇭🇺Budapest, Hungary
Yoshida Internal Medicine Clinic
🇯🇵Sakaki, Nagano, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Ambulatorium Sp. z o.o.
🇵🇱Elbląg, Warmińsko-mazurskie, Poland
Koujunkai Daido Clinic
🇯🇵Nagoya, Aichi, Japan
Hospital Córdoba
🇦🇷Córdoba, Argentina
Sagawa Akira Rheumatology Clinic
🇯🇵Sapporo, Hokkaido, Japan
CHUAC-Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, A Coruña [La Coruña], Spain
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Tonan Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hospital Quiron Infanta Luisa
🇪🇸Sevilla, Spain
CHUS - Hospital Clinico Universitario
🇪🇸Santiago de Compostela, Galicia [Galicia], Spain
Tobata General Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Szpital Uniwersytecki Nr 2 w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
🇵🇱Poznan, Wielkopolskie, Poland
Twoja Przychodnia Poznanskie Centrum Medyczne
🇵🇱Poznań, Wielkopolskie, Poland
Clínica Gaias - Santiago
🇪🇸Santiago de Compostela, A Coruña [La Coruña], Spain
National Hospital Organization Chibahigashi National Hospital
🇯🇵Chiba, Japan
Osi Bilbao-Basurto
🇪🇸Bilbao, País Vasco, Spain
Kohler and Milstein Research S.A. de C.V.
🇲🇽Mérida, Yucatán, Mexico
Investigacion y Biomedicina de Chihuahua
🇲🇽Chihuahua, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
🇲🇽Guadalajara, Jalisco, Mexico
CIPREC
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Médicas Tucuman
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
APRILLUS Asistencia E Investigacion
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
Nova Reuma Społka Partnerska
🇵🇱Bialystok, Podlaskie, Poland
Centro Medico del Angel
🇲🇽Mexicali, Baja California, Mexico
The First Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Sasebo Chuo Hospital
🇯🇵Sasebo, Nagasaki, Japan
Hirose Clinic - Tokorozawa
🇯🇵Tokorozawa, Saitama, Japan
Nagaoka Red Cross Hospital
🇯🇵Nagaoka, Niigata, Japan
Hiroshima Clinic
🇯🇵Hiroshima, Japan
Bayside Misato Medical Center
🇯🇵Kochi, Japan
Okayama City General Medical Center Okayama City Hospital
🇯🇵Okayama, Japan
Machida Municipal Hospital
🇯🇵Tokyo, Japan
Vital Medical Center
🇭🇺Veszprem, Veszprém City, Hungary
Accel Research Sites - Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States
Arizona Arthritis & Rheumatology Associates, PLLC
🇺🇸Phoenix, Arizona, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Health Research of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
HARAC Research Corp
🇺🇸Avon Park, Florida, United States
Arizona Arthritis & Rheumatology Research PLLC
🇺🇸Gilbert, Arizona, United States
Medvin Clinical Research - Metyas
🇺🇸Covina, California, United States
Newport Huntington Medical Group
🇺🇸Huntington Beach, California, United States
Encore Medical Research of Boynton Beach
🇺🇸Boynton Beach, Florida, United States
Tekton Research - Fort Collins - East Harmony Road
🇺🇸Fort Collins, Colorado, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
Baycare Medical Group
🇺🇸Tampa, Florida, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
West Broward Rheumatology Associates
🇺🇸Tamarac, Florida, United States
AA Medical Research Center
🇺🇸Grand Blanc, Michigan, United States
Hinsdale Orthopaedics - llinois Bone & Joint Institute
🇺🇸Hinsdale, Illinois, United States
Arthritis & Osteoporosis Associates - Freehold
🇺🇸Freehold, New Jersey, United States
Arthritis and Rheumatology Center of MI - Rochester Hills
🇺🇸Rochester Hills, Michigan, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Saint Louis Rheumatology
🇺🇸Saint Louis, Missouri, United States
DJL Clinical Research, PLLC
🇺🇸Charlotte, North Carolina, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
🇺🇸Brooklyn, New York, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Sound Clinical Research, LLC
🇺🇸Bothell, Washington, United States
DM Clinical Research - Tomball
🇺🇸Tomball, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Accurate Clinical Management - Houston
🇺🇸Houston, Texas, United States
Rheumatology & Pulmonary Clinic
🇺🇸Beckley, West Virginia, United States
DM Clinical Research/Rheumatology Clinic of Houston
🇺🇸Tomball, Texas, United States
Arthritis Northwest, PLLC
🇺🇸Spokane, Washington, United States
Clinica Adventista Belgrano
🇦🇷Caba, Ciudad Autónoma De Buenos Aire, Argentina
Instituto Medico Strusberg
🇦🇷Córdoba, Argentina
Centre de Recherche Musculo-Squelettique
🇨🇦Trois-Rivières, Quebec, Canada
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
🇦🇷San Juan, Argentina
Attikon General University Hospital
🇬🇷Chaidari, Attikí, Greece
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
Huashan Hospital Affiliated Fudan University
🇨🇳Shanghai, Shanghai, China
General Hospital of Athens Hippokratio
🇬🇷Athens, Attikí, Greece
Shinonoi General Hospital
🇯🇵Nagano, Japan
Juntendo University Urayasu Hospital
🇯🇵Urayasu, Chiba, Japan
Shinkokura Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Nagasaki Internal Medicine- Rheumatology Hospital
🇯🇵Nagasaki, Japan
Rheuma Medicus- Zak��ad Opieki Zdrowotnej
🇵🇱Warszawa, Mazowieckie, Poland
Twoja Przychodnia NCM
🇵🇱Nowa Sol, Lubuskie, Poland
Centrum Medyczne Reuma Park
🇵🇱Warszawa, Mazowieckie, Poland
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China