A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— RESOLUTION-1  

Official title:

A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05516758
• Other study ID #: 18525
• Secondary ID: J1A-MC-KDAF2022-
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 31, 2022
• Est. completion date: January 23, 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 491
• Est. completion date: January 23, 2025
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Collagen Diseases
• Connective Tissue Diseases
• Immune System Diseases
• Joint Diseases
• Musculoskeletal Diseases
• Rheumatic Diseases
• Rheumatoid Arthritis

Intervention

Drug:
• Peresolimab
Administered subcutaneously (SC)
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	CIPREC	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Fundación Respirar	Buenos Aires
Argentina	APRILLUS Asistencia E Investigacion	Caba	Ciudad Aut
Argentina	Clinica Adventista Belgrano	Caba	Ciudad Autónoma De Buenos Aire
Argentina	Organizacion Medica de Investigacion	Caba	Buenos Aires
Argentina	Centro Privado de Medicina Familiar / Mindout Research	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	Hospital Córdoba	Córdoba
Argentina	Instituto Medico Strusberg	Córdoba
Argentina	CER San Juan	San Juan
Argentina	Centro de Investigaciones Reumatológicas	San Miguel de Tucumán	Tucumán
Argentina	Centro Medico Privado de Reumatologia	San Miguel De Tucumán	Tucumán
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.	Quebec
Canada	Centre de Recherche Musculo-Squelettique	Trois-Rivières	Quebec
China	Afflilated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Huashan Hospital Affiliated Fudan University	Shanghai	Shanghai
China	The First Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	ShenZhen People's Hospital	Shenzhen	Guangdong
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
Greece	University Hospital of Alexandroupolis	Alexandroupolis	Évros
Greece	General Hospital of Athens Hippokratio	Athens	Attikí
Greece	General Hospital of Athens Laiko	Athens	Attikí
Greece	Attikon General University Hospital	Chaidari	Attikí
Greece	University General Hospital of Heraklion	Heraklion	Krítí
Hungary	Qualiclinic	Budapest
Hungary	Revita Clinic	Budapest	Pest
Hungary	Vital Medical Center	Veszprem	Veszprém City
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	National Hospital Organization Chibahigashi National Hospital	Chiba
Japan	Hiroshima Clinic	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Shinkokura Hospital	Kitakyushu	Fukuoka
Japan	Tobata General Hospital	Kitakyushu	Fukuoka
Japan	University of Occupational and Enviromental Health	Kitakyushu	Fukuoka
Japan	Bayside Misato Medical Center	Kochi
Japan	Shinonoi General Hospital	Nagano
Japan	Nagaoka Red Cross Hospital	Nagaoka	Niigata
Japan	Nagasaki Internal Medicine- Rheumatology Hospital	Nagasaki
Japan	Chubu Rosai Hospital	Nagoya	Aichi
Japan	Koujunkai Daido Clinic	Nagoya	Aichi
Japan	Okayama City General Medical Center Okayama City Hospital	Okayama
Japan	Yoshida Internal Medicine Clinic	Sakaki	Nagano
Japan	Sagawa Akira Rheumatology Clinic	Sapporo	Hokkaido
Japan	Tonan Hospital	Sapporo	Hokkaido
Japan	Sasebo Chuo Hospital	Sasebo	Nagasaki
Japan	Hirose Clinic - Tokorozawa	Tokorozawa	Saitama
Japan	Machida Municipal Hospital	Tokyo
Japan	Juntendo University Urayasu Hospital	Urayasu	Chiba
Mexico	Investigacion y Biomedicina de Chihuahua	Chihuahua
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S. C.	Guadalajara	Jalisco
Mexico	Kohler and Milstein Research S.A. de C.V.	Mérida	Yucatán
Mexico	Centro Medico del Angel	Mexicali	Baja California
Mexico	Clinstile, S.A. de C.V.	Mexico	Distrito Federal
Poland	Nova Reuma Spolka Partnerska	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej	Bydgoszcz	Kujawsko-pomorskie
Poland	BIF-MED	Bytom	Slaskie
Poland	Ambulatorium Barbara Bazela	Elblag	Warminsko-mazurskie
Poland	Twoja Przychodnia Centrum Medyczne Nowa Sol	Nowa Sol	Lubuskie
Poland	Ai Centrum Medyczne Sp. Z O.O. Sp.K.	Poznan	Wielkopolskie
Poland	Twoja Przychodnia Poznanskie Centrum Medyczne	Poznan	Wielkopolskie
Poland	Centrum Medyczne Reuma Park	Warszawa	Mazowieckie
Poland	Medycyna Kliniczna	Warszawa	Mazowieckie
Poland	Rheuma Medicus- Zak??ad Opieki Zdrowotnej	Warszawa	Mazowieckie
Puerto Rico	Centro Reumatologico Caguas	Caguas
Puerto Rico	GCM Medical Group, PSC - Hato Rey Site	San Juan
Puerto Rico	Latin Clinical Trial Center	San Juan
Puerto Rico	Mindful Medical Research	San Juan
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña	A Coruña	A Coruña [La Coruña]
Spain	Osi Bilbao-Basurto	Bilbao	País Vasco
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	CHUS - Hospital Clinico Universitario	Santiago de Compostela	Galicia [Galicia]
Spain	Clínica Gaias - Santiago	Santiago de Compostela	A Coruña [La Coruña]
Spain	Hospital Quiron Infanta Luisa	Sevilla
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	HARAC Research Corp	Avon Park	Florida
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Accurate Clinical Management	Baytown	Texas
United States	Rheumatology & Pulmonary Clinic	Beckley	West Virginia
United States	Accel Research Sites - Birmingham Clinical Research Unit	Birmingham	Alabama
United States	Sound Clinical Research, LLC	Bothell	Washington
United States	Encore Medical Research of Boynton Beach	Boynton Beach	Florida
United States	Joseph S. and Diane H. Steinberg Ambulatory Care Center	Brooklyn	New York
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Great Lakes Clinical Trials - Ravenswood	Chicago	Illinois
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	Medvin Clinical Research - Metyas	Covina	California
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Denver Arthritis Clinic	Denver	Colorado
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Tekton Research - Fort Collins - East Harmony Road	Fort Collins	Colorado
United States	Arthritis & Osteoporosis Associates - Freehold	Freehold	New Jersey
United States	Providence Medical Foundation	Fullerton	California
United States	Arizona Arthritis & Rheumatology Research PLLC	Gilbert	Arizona
United States	Arizona Arthritis & Rheumatology Research, PLLC	Glendale	Arizona
United States	AA Medical Research Center	Grand Blanc	Michigan
United States	Piedmont Arthritis Clinic	Greenville	South Carolina
United States	Hinsdale Orthopaedics - llinois Bone & Joint Institute	Hinsdale	Illinois
United States	Accurate Clinical Management - Houston	Houston	Texas
United States	Accurate Clinical Research	Houston	Texas
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Laila A Hassan, MD, PA	Houston	Texas
United States	Christine Thai, MD	Huntington Beach	California
United States	Accurate Clinical Research	Lake Charles	Louisiana
United States	Cape Fear Arthritis Care	Leland	North Carolina
United States	Arizona Arthritis & Rheumatology Research, PLLC	Mesa	Arizona
United States	Paramount Medical Research & Consulting, LLC	Middleburg Heights	Ohio
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Health Research of Oklahoma	Oklahoma City	Oklahoma
United States	Arizona Arthritis & Rheumatology Associates	Phoenix	Arizona
United States	Desert Medical Advances	Rancho Mirage	California
United States	Arthritis and Rheumatology Center of MI - Rochester Hills	Rochester Hills	Michigan
United States	Saint Louis Rheumatology	Saint Louis	Missouri
United States	Baycare Medical Group	Saint Petersburg	Florida
United States	Wolverine Clinical Trials	Santa Ana	California
United States	Arthritis Northwest, PLLC	Spokane	Washington
United States	Clinvest Research LLC	Springfield	Missouri
United States	West Broward Rheumatology Associates	Tamarac	Florida
United States	Baycare Medical Group	Tampa	Florida
United States	Clinical Research of West Florida	Tampa	Florida
United States	ForCare Clinical Research	Tampa	Florida
United States	DM Clinical Research - Tomball	Tomball	Texas
United States	DM Clinical Research/Rheumatology Clinic of Houston	Tomball	Texas
United States	Dan La, MD Inc	Tujunga	California
United States	Medvin Clinical Research - Su	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  China,  Greece,  Hungary,  Japan,  Mexico,  Poland,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving American College of Rheumatology (ACR)20	ACR20 - 20% improvement in the ACR core set values	Baseline to Week 12
Secondary	Percentage of Participants Achieving ACR50 or ACR70	ACR50 - 50% improvement in the ACR core set values or ACR70 - 70% improvement in the ACR core set values	Baseline to Week 12
Secondary	Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)		Week 12
Secondary	Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI)		Week 12
Secondary	Change from Baseline in DAS28-hsCRP		Baseline, Week 12
Secondary	Change from Baseline in CDAI		Baseline, Week 12
Secondary	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
Secondary	Pharmacokinetics (PK): Observed Trough Drug Concentration		Baseline to Week 12

External Links

•   A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (RESOLUTION-1)