Clinical trial NCT05516758: A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Official title: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-08-26
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology (ACR)20
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving ACR50 or ACR70
timeFrame: Baseline to Week 12
measure: Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
timeFrame: Week 12
measure: Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI)
timeFrame: Week 12
measure: Change from Baseline in DAS28-hsCRP
timeFrame: Baseline, Week 12
measure: Change from Baseline in CDAI
timeFrame: Baseline, Week 12
measure: 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)
timeFrame: Baseline, Week 12
measure: Pharmacokinetics (PK): Observed Trough Drug Concentration
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites - Birmingham Clinical Research Unit
state: Alabama
city: Gilbert
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, PLLC
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research - Metyas
state: California
city: Fullerton
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: Rancho Mirage
country: United States
facility: Desert Medical Advances
state: California
city: Tujunga
country: United States
facility: Dan La, MD Inc
state: California
city: Tustin
country: United States
facility: Wolverine Clinical Trials
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research - Su
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Fort Collins
country: United States
facility: Tekton Research - Fort Collins - East Harmony Road
state: Colorado
city: Avon Park
country: United States
facility: HARAC Research Corp
state: Florida
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Baycare Medical Group
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Baycare Medical Group
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Hinsdale
country: United States
facility: Hinsdale Orthopaedics - llinois Bone & Joint Institute
state: Illinois
city: Lake Charles
country: United States
facility: Accurate Clinical Research
state: Louisiana
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Grand Blanc
country: United States
facility: AA Medical Research Center
state: Michigan
city: Rochester Hills
country: United States
facility: Arthritis and Rheumatology Center of MI - Rochester Hills
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis Rheumatology
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Freehold
country: United States
facility: Arthritis & Osteoporosis Associates - Freehold
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Brooklyn
country: United States
facility: Joseph S. and Diane H. Steinberg Ambulatory Care Center
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic
state: South Carolina
city: Austin
country: United States
facility: Tekton Research, Inc
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Management
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management - Houston
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Houston
country: United States
facility: Laila A Hassan, MD, PA
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research/Rheumatology Clinic of Houston
state: Texas
city: Bothell
country: United States
facility: Sound Clinical Research, LLC
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Beckley
country: United States
facility: Rheumatology & Pulmonary Clinic
state: West Virginia
city: Caba
country: Argentina
facility: Organizacion Medica de Investigacion
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro Privado de Medicina Familiar / Mindout Research
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: APRILLUS Asistencia E Investigacion
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: Clinica Adventista Belgrano
state: Ciudad Autónoma De Buenos Aire
city: San Miguel de Tucumán
country: Argentina
facility: Centro de Investigaciones Reumatológicas
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Córdoba
country: Argentina
facility: Hospital Córdoba
city: Córdoba
country: Argentina
facility: Instituto Medico Strusberg
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Trois-Rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Quebec
country: Canada
facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
city: Bengbu
country: China
facility: Afflilated Hospital of Bengbu Medical College
state: Anhui
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shantou
country: China
facility: The First Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: ShenZhen People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Shanghai
country: China
facility: Huashan Hospital Affiliated Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Athens
country: Greece
facility: General Hospital of Athens Hippokratio
state: Attikí
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
state: Attikí
city: Chaidari
country: Greece
facility: Attikon General University Hospital
state: Attikí
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Krítí
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Évros
city: Budapest
country: Hungary
facility: Revita Clinic
state: Pest
city: Veszprem
country: Hungary
facility: Vital Medical Center
state: Veszprém City
city: Budapest
country: Hungary
facility: Qualiclinic
city: Nagoya
country: Japan
facility: Chubu Rosai Hospital
state: Aichi
city: Nagoya
country: Japan
facility: Koujunkai Daido Clinic
state: Aichi
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Kitakyushu
country: Japan
facility: Shinkokura Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Tobata General Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: University of Occupational and Enviromental Health
state: Fukuoka
city: Sapporo
country: Japan
facility: Sagawa Akira Rheumatology Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Tonan Hospital
state: Hokkaido
city: Sakaki
country: Japan
facility: Yoshida Internal Medicine Clinic
state: Nagano
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Nagaoka
country: Japan
facility: Nagaoka Red Cross Hospital
state: Niigata
city: Tokorozawa
country: Japan
facility: Hirose Clinic - Tokorozawa
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Clinic
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kochi
country: Japan
facility: Bayside Misato Medical Center
city: Nagano
country: Japan
facility: Shinonoi General Hospital
city: Nagasaki
country: Japan
facility: Nagasaki Internal Medicine- Rheumatology Hospital
city: Okayama
country: Japan
facility: Okayama City General Medical Center Okayama City Hospital
city: Tokyo
country: Japan
facility: Machida Municipal Hospital
city: Mexicali
country: Mexico
facility: Centro Medico del Angel
state: Baja California
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.
state: Jalisco
city: Mérida
country: Mexico
facility: Kohler and Milstein Research S.A. de C.V.
state: Yucatán
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy
state: Kujawsko-pomorskie
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia NCM
state: Lubuskie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Warszawa
country: Poland
facility: Rheuma Medicus- Zak��ad Opieki Zdrowotnej
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park
state: Mazowieckie
city: Bialystok
country: Poland
facility: Nova Reuma Społka Partnerska
state: Podlaskie
city: Elbląg
country: Poland
facility: Ambulatorium Sp. z o.o.
state: Warmińsko-mazurskie
city: Poznan
country: Poland
facility: Ai Centrum Medyczne Sp. Z O.O. Sp.K.
state: Wielkopolskie
city: Poznań
country: Poland
facility: Twoja Przychodnia Poznanskie Centrum Medyczne
state: Wielkopolskie
city: Bytom
country: Poland
facility: Nzoz Bif-Med
state: Śląskie
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico Caguas
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: Santiago de Compostela
country: Spain
facility: Clínica Gaias - Santiago
state: A Coruña [La Coruña]
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: Galicia [Galicia]
city: Bilbao
country: Spain
facility: Osi Bilbao-Basurto
state: País Vasco
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: