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

NCT ID: NCT05516758

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 491 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2025-01-17

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.

Conditions

Rheumatoid Arthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Peresolimab 1000 mg SC Q4W

Participants received peresolimab 1000 milligram (mg) subcutaneously (SC) once every 4 weeks (Q4W) from Week 0 to Week 24. At Week 24, based on their Clinical Disease Activity Index (CDAI) score, participants continued peresolimab 1000 mg SC Q4W from Week 24 to Week 60.

Group Type: EXPERIMENTAL

Peresolimab

Intervention Type: DRUG

Administered SC

Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W

Participants received peresolimab 1000 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 1000 mg SC once every 12 weeks (Q12W) from Week 24 to Week 60.

Group Type: EXPERIMENTAL

Peresolimab

Intervention Type: DRUG

Administered SC

Peresolimab 400 mg SC Q4W

Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants continued peresolimab 400 mg SC Q4W from Week 24 to Week 60.

Group Type: EXPERIMENTAL

Peresolimab

Intervention Type: DRUG

Administered SC

Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W

Participants received peresolimab 400 mg SC Q4W from Week 0 to Week 24. At Week 24, based on their CDAI score, participants switched to peresolimab 400 mg SC Q12W from Week 24 to Week 60.

Group Type: EXPERIMENTAL

Peresolimab

Intervention Type: DRUG

Administered SC

Peresolimab 100 mg SC Q4W

Participants received peresolimab 100 mg SC Q4W from Week 0 to Week 60.

Group Type: EXPERIMENTAL

Peresolimab

Intervention Type: DRUG

Administered SC

Placebo SC Q4W to Peresolimab 1000 mg SC Q4W

Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 1000 mg SC Q4W from Week 12 to Week 60.

Group Type: EXPERIMENTAL

Peresolimab

Intervention Type: DRUG

Administered SC

Placebo

Intervention Type: DRUG

Administered SC

Placebo SC Q4W to Peresolimab 400 mg SC Q4W

Participants received peresolimab-matched placebo SC Q4W from Week 0 to Week 12 and then switched to peresolimab 400 mg SC Q4W from Week 12 to Week 60.

Group Type: EXPERIMENTAL

Peresolimab

Intervention Type: DRUG

Administered SC

Placebo

Intervention Type: DRUG

Administered SC

Interventions

Peresolimab

Administered SC

Intervention Type: DRUG

Placebo

Administered SC

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Arizona Arthritis & Rheumatology Research PLLC

Gilbert, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Glendale, Arizona, United States

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, United States

Arizona Arthritis & Rheumatology Associates, PLLC

Phoenix, Arizona, United States

Medvin Clinical Research - Metyas

Covina, California, United States

St Joseph Heritage Healthcare

Fullerton, California, United States

Newport Huntington Medical Group

Huntington Beach, California, United States

Desert Medical Advances

Rancho Mirage, California, United States

Dan La, MD Inc

Tujunga, California, United States

Wolverine Clinical Trials

Tustin, California, United States

Medvin Clinical Research - Su

Whittier, California, United States

Denver Arthritis Clinic

Denver, Colorado, United States

Tekton Research - Fort Collins - East Harmony Road

Fort Collins, Colorado, United States

HARAC Research Corp

Avon Park, Florida, United States

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, United States

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, United States

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Baycare Medical Group

St. Petersburg, Florida, United States

West Broward Rheumatology Associates

Tamarac, Florida, United States

Clinical Research of West Florida

Tampa, Florida, United States

ForCare Clinical Research

Tampa, Florida, United States

Baycare Medical Group

Tampa, Florida, United States

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Hinsdale Orthopaedics - llinois Bone & Joint Institute

Hinsdale, Illinois, United States

Accurate Clinical Research

Lake Charles, Louisiana, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

AA Medical Research Center

Grand Blanc, Michigan, 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

St Louis, Missouri, United States

Arthritis & Osteoporosis Associates - Freehold

Freehold, New Jersey, United States

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 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

Cape Fear Arthritis Care

Leland, North Carolina, United States

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Piedmont Arthritis Clinic

Greenville, South Carolina, United States

Tekton Research, Inc

Austin, Texas, United States

Accurate Clinical Management

Baytown, Texas, United States

Metroplex Clinical Research Center

Dallas, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Accurate Clinical Management - Houston

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Accurate Clinical Research

Houston, Texas, United States

Laila A Hassan, MD, PA

Houston, Texas, United States

DM Clinical Research - Tomball

Tomball, Texas, United States

DM Clinical Research/Rheumatology Clinic of Houston

Tomball, Texas, United States

Sound Clinical Research, LLC

Bothell, Washington, United States

Arthritis Northwest, PLLC

Spokane, Washington, United States

Rheumatology & Pulmonary Clinic

Beckley, West Virginia, 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

CIPREC

Buenos Aires, Buenos Aires F.D., Argentina

APRILLUS Asistencia E Investigacion

CABA, Buenos Aires F.D., Argentina

Clinica Adventista Belgrano

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Médicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Fundación Respirar

Buenos Aires, , Argentina

Hospital Córdoba

Córdoba, , Argentina

Instituto Medico Strusberg

Córdoba, , Argentina

Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

San Juan, , Argentina

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, Canada

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

Québec, , Canada

Afflilated Hospital of Bengbu Medical College

Bengbu, Anhui, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 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, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Jiangxi Pingxiang People's Hospital

Pingxiang, Jiangxi, China

Huashan Hospital Affiliated Fudan University

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

General Hospital of Athens Hippokratio

Athens, Attikí, Greece

General Hospital of Athens Laiko

Athens, Attikí, Greece

Attikon General University Hospital

Chaïdári, Attikí, Greece

University General Hospital of Heraklion

Heraklion, Krítí, Greece

University Hospital of Alexandroupolis

Alexandroupoli, Évros, Greece

Revita Clinic

Budapest, Pest County, Hungary

Vital Medical Center

Veszprém, Veszprém City, Hungary

Qualiclinic

Budapest, , Hungary

Chubu Rosai Hospital

Nagoya, Aichi-ken, Japan

Koujunkai Daido Clinic

Nagoya, Aichi-ken, Japan

Juntendo University Urayasu Hospital

Urayasu, Chiba, Japan

Shinkokura Hospital

Kitakyushu, Fukuoka, Japan

Tobata General Hospital

Kitakyushu, Fukuoka, Japan

University of Occupational and Enviromental Health

Kitakyushu, Fukuoka, Japan

Sagawa Akira Rheumatology Clinic

Sapporo, Hokkaido, Japan

Tonan Hospital

Sapporo, Hokkaido, Japan

Yoshida Internal Medicine Clinic

Sakaki, Nagano, Japan

Sasebo Chuo Hospital

Sasebo, Nagasaki, Japan

Nagaoka Red Cross Hospital

Nagaoka, Niigata, Japan

Hirose Clinic - Tokorozawa

Tokorozawa, Saitama, 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

Bayside Misato Medical Center

Kochi, , Japan

Shinonoi General Hospital

Nagano, , Japan

Nagasaki Internal Medicine- Rheumatology Hospital

Nagasaki, , Japan

Okayama City General Medical Center Okayama City Hospital

Okayama, , Japan

Machida Municipal Hospital

Tokyo, , Japan

Centro Medico del Angel

Mexicali, Estado de Baja California, Mexico

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Jalisco, Mexico

Clinstile, S.A. de C.V.

Mexico City, Mexico City, Mexico

Kohler and Milstein Research S.A. de C.V.

Mérida, Yucatán, Mexico

Investigacion y Biomedicina de Chihuahua

Chihuahua City, , Mexico

Ai Centrum Medyczne Sp. Z O.O. Sp.K.

Poznan, Greater Poland Voivodeship, Poland

Twoja Przychodnia Poznanskie Centrum Medyczne

Poznan, Greater Poland Voivodeship, Poland

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Twoja Przychodnia NCM

Nowa Sól, Lubusz Voivodeship, Poland

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, Poland

Rheuma Medicus- Zak��ad Opieki Zdrowotnej

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship, Poland

Nova Reuma Społka Partnerska

Bialystok, Podlaskie Voivodeship, Poland

Nzoz Bif-Med

Bytom, Silesian Voivodeship, Poland

Ambulatorium Sp. z o.o.

Elblag, Warmian-Masurian Voivodeship, Poland

Centro Reumatologico Caguas

Caguas, , Puerto Rico

Latin Clinical Trial Center

San Juan, , Puerto Rico

GCM Medical Group, PSC - Hato Rey Site

San Juan, , Puerto Rico

Mindful Medical Research

San Juan, , Puerto Rico

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], Spain

Clínica Gaias - Santiago

Santiago de Compostela, A Coruña [La Coruña], Spain

Osi Bilbao-Basurto

Bilbao, Basque Country, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

CHUS - Hospital Clinico Universitario

Santiago de Compostela, Galicia [Galicia], Spain

Hospital Quiron Infanta Luisa

Seville, , Spain

Countries

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lilly.com/en-US/trial/356796

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

Other Identifiers

J1A-MC-KDAF

Identifier Type: OTHER

Identifier Source: secondary_id

2022-501425-20-00

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1283-9566

Identifier Type: OTHER

Identifier Source: secondary_id

18525

Identifier Type: -

Identifier Source: org_study_id