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

NCT05516758 | Terminated Phase 2 Results FDA Drug

• 4 other identifiers: 18525J1A-MC-KDAF2022-501425-20-00U1111-1283-9566
• Study Type: interventional
• Target: 491
• Locations: 11 countries
• Sites: 131

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

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12

  The ACR20 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR20 responders were participants with at least 20% improvement from baseline in tender joint count (TJC) and swollen joint count (SJC), and at least 20% improvement in 3 of the 5 remaining core measures: Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response= (number of ACR20 responders)/ (number of participants analyzed) \*100.

  Week 12

Secondary Outcomes (10)

• Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 12

  Week 12

• Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70) Response at Week 12

  Week 12

• Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Score Modified to Include the 28 Diarthrodial Joint Count-High-Sensitivity C-Reactive Protein (DAS28-hsCRP) ≤3.2 at Week 12

  Week 12

• Percentage of Participants With Remission According to DAS28-hsCRP Score <2.6 at Week 12

  Week 12

• Percentage of Participants Achieving LDA According to Clinical Disease Activity Index (CDAI) Score ≤10 at Week 12

  Week 12

Study Arms (7)

Peresolimab 1000 mg SC Q4W

EXPERIMENTAL

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.

Drug: Peresolimab

Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W

EXPERIMENTAL

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.

Drug: Peresolimab

Peresolimab 400 mg SC Q4W

EXPERIMENTAL

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.

Drug: Peresolimab

Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W

EXPERIMENTAL

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.

Drug: Peresolimab

Peresolimab 100 mg SC Q4W

EXPERIMENTAL

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

Drug: Peresolimab

Placebo SC Q4W to Peresolimab 1000 mg SC Q4W

EXPERIMENTAL

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.

Drug: Peresolimab; Drug: Placebo

Placebo SC Q4W to Peresolimab 400 mg SC Q4W

EXPERIMENTAL

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.

Drug: Peresolimab; Drug: Placebo

Interventions

Placebo DRUG

Administered SC

Placebo SC Q4W to Peresolimab 1000 mg SC Q4W; Placebo SC Q4W to Peresolimab 400 mg SC Q4W

Peresolimab DRUG

Administered SC

Peresolimab 100 mg SC Q4W; Peresolimab 1000 mg SC Q4W; Peresolimab 1000 mg SC Q4W to Peresolimab 1000 mg SC Q12W; Peresolimab 400 mg SC Q4W; Peresolimab 400 mg SC Q4W to Peresolimab 400 mg SC Q12W; Placebo SC Q4W to Peresolimab 1000 mg SC Q4W; Placebo SC Q4W to Peresolimab 400 mg SC Q4W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (131)

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, 35216, United States

Location

Arizona Arthritis & Rheumatology Research PLLC

Gilbert, Arizona, 85297, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Glendale, Arizona, 85306, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, 85210, United States

Location

Arizona Arthritis & Rheumatology Associates, PLLC

Phoenix, Arizona, 85037, United States

Location

Medvin Clinical Research - Metyas

Covina, California, 91722, United States

Location

St Joseph Heritage Healthcare

Fullerton, California, 92835, United States

Location

Newport Huntington Medical Group

Huntington Beach, California, 92648, United States

Location

Desert Medical Advances

Rancho Mirage, California, 92270, United States

Location

Dan La, MD Inc

Tujunga, California, 91042, United States

Location

Wolverine Clinical Trials

Tustin, California, 92780, United States

Location

Medvin Clinical Research - Su

Whittier, California, 90602, United States

Location

Denver Arthritis Clinic

Denver, Colorado, 80230, United States

Location

Tekton Research - Fort Collins - East Harmony Road

Fort Collins, Colorado, 80528, United States

Location

HARAC Research Corp

Avon Park, Florida, 33825, United States

Location

Encore Medical Research of Boynton Beach

Boynton Beach, Florida, 33436, United States

Location

Clinical Research of West Florida, Inc. (Clearwater)

Clearwater, Florida, 33765, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Baycare Medical Group

St. Petersburg, Florida, 33705, United States

Location

West Broward Rheumatology Associates

Tamarac, Florida, 33321, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33606, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Baycare Medical Group

Tampa, Florida, 33614, United States

Location

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, 60640, United States

Location

Hinsdale Orthopaedics - llinois Bone & Joint Institute

Hinsdale, Illinois, 60521, United States

Location

Accurate Clinical Research

Lake Charles, Louisiana, 70605, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

AA Medical Research Center

Grand Blanc, Michigan, 48439, United States

Location

Arthritis and Rheumatology Center of MI - Rochester Hills

Rochester Hills, Michigan, 48307, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65807, United States

Location

Saint Louis Rheumatology

St Louis, Missouri, 63119, United States

Location

Arthritis & Osteoporosis Associates - Freehold

Freehold, New Jersey, 07728, United States

Location

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, 87102, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Joseph S. and Diane H. Steinberg Ambulatory Care Center

Brooklyn, New York, 11201, United States

Location

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28211, United States

Location

Cape Fear Arthritis Care

Leland, North Carolina, 28451, United States

Location

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Piedmont Arthritis Clinic

Greenville, South Carolina, 29601, United States

Location

Tekton Research, Inc

Austin, Texas, 78745, United States

Location

Accurate Clinical Management

Baytown, Texas, 77521, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Accurate Clinical Management - Houston

Houston, Texas, 77084, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

Accurate Clinical Research

Houston, Texas, 77089, United States

Location

Laila A Hassan, MD, PA

Houston, Texas, 77089, United States

Location

DM Clinical Research - Tomball

Tomball, Texas, 77375, United States

Location

DM Clinical Research/Rheumatology Clinic of Houston

Tomball, Texas, 77377, United States

Location

Sound Clinical Research, LLC

Bothell, Washington, 98021, United States

Location

Arthritis Northwest, PLLC

Spokane, Washington, 99204, United States

Location

Rheumatology & Pulmonary Clinic

Beckley, West Virginia, 25801, United States

Location

Organizacion Medica de Investigacion

CABA, Buenos Aires, C1015, Argentina

Location

Centro Privado de Medicina Familiar / Mindout Research

Ciudad Autónoma de Buenos Aire, Buenos Aires, 1417, Argentina

Location

CIPREC

Buenos Aires, Buenos Aires F.D., C1061AAS, Argentina

Location

APRILLUS Asistencia E Investigacion

CABA, Buenos Aires F.D., 1406, Argentina

Location

Clinica Adventista Belgrano

CABA, Ciudad Autónoma de Buenos Aire, C1430EGF, Argentina

Location

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro de Investigaciones Médicas Tucuman

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Fundación Respirar

Buenos Aires, C1426ABP, Argentina

Location

Hospital Córdoba

Córdoba, 5004, Argentina

Location

Instituto Medico Strusberg

Córdoba, X5000EDC, Argentina

Location

Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

San Juan, 5400, Argentina

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G9A 3Y2, Canada

Location

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

Québec, G1V 3M7, Canada

Location

Afflilated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

Location

ShenZhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Tongji Hospital Tongji Medical,Science & Technology

Wuhan, Hubei, 430030, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Jiangxi Pingxiang People's Hospital

Pingxiang, Jiangxi, 337055, China

Location

Huashan Hospital Affiliated Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

General Hospital of Athens Hippokratio

Athens, Attikí, 115 27, Greece

Location

General Hospital of Athens Laiko

Athens, Attikí, 11527, Greece

Location

Attikon General University Hospital

Chaïdári, Attikí, 12462, Greece

Location

University General Hospital of Heraklion

Heraklion, Krítí, 711 10, Greece

Location

University Hospital of Alexandroupolis

Alexandroupoli, Évros, 68100, Greece

Location

Revita Clinic

Budapest, Pest County, 1027, Hungary

Location

Vital Medical Center

Veszprém, Veszprém City, 8200, Hungary

Location

Qualiclinic

Budapest, 1036, Hungary

Location

Chubu Rosai Hospital

Nagoya, Aichi-ken, 455-8530, Japan

Location

Koujunkai Daido Clinic

Nagoya, Aichi-ken, 457-8511, Japan

Location

Juntendo University Urayasu Hospital

Urayasu, Chiba, 279-0021, Japan

Location

Shinkokura Hospital

Kitakyushu, Fukuoka, 803-0816, Japan

Location

Tobata General Hospital

Kitakyushu, Fukuoka, 804-0025, Japan

Location

University of Occupational and Enviromental Health

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Sagawa Akira Rheumatology Clinic

Sapporo, Hokkaido, 060-0001, Japan

Location

Tonan Hospital

Sapporo, Hokkaido, 060-0004, Japan

Location

Yoshida Internal Medicine Clinic

Sakaki, Nagano, 389-0606, Japan

Location

Sasebo Chuo Hospital

Sasebo, Nagasaki, 857-1195, Japan

Location

Nagaoka Red Cross Hospital

Nagaoka, Niigata, 940-2108, Japan

Location

Hirose Clinic - Tokorozawa

Tokorozawa, Saitama, 359-1111, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

National Hospital Organization Chibahigashi National Hospital

Chiba, 260-8712, Japan

Location

Hiroshima Clinic

Hiroshima, 733-0032, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Bayside Misato Medical Center

Kochi, 781-0112, Japan

Location

Shinonoi General Hospital

Nagano, 388-8004, Japan

Location

Nagasaki Internal Medicine- Rheumatology Hospital

Nagasaki, 850-0832, Japan

Location

Okayama City General Medical Center Okayama City Hospital

Okayama, 700-8557, Japan

Location

Machida Municipal Hospital

Tokyo, 194-0023, Japan

Location

Centro Medico del Angel

Mexicali, Estado de Baja California, 21100, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad S. C.

Guadalajara, Jalisco, 44650, Mexico

Location

Clinstile, S.A. de C.V.

Mexico City, Mexico City, 06700, Mexico

Location

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

Mérida, Yucatán, 97070, Mexico

Location

Investigacion y Biomedicina de Chihuahua

Chihuahua City, 31000, Mexico

Location

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

Poznan, Greater Poland Voivodeship, 61-113, Poland

Location

Twoja Przychodnia Poznanskie Centrum Medyczne

Poznan, Greater Poland Voivodeship, 61-293, Poland

Location

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Twoja Przychodnia NCM

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Rheuma Medicus- Zak��ad Opieki Zdrowotnej

Warsaw, Masovian Voivodeship, 02-118, Poland

Location

Centrum Medyczne Reuma Park

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

Nova Reuma Społka Partnerska

Bialystok, Podlaskie Voivodeship, 15-707, Poland

Location

Nzoz Bif-Med

Bytom, Silesian Voivodeship, 41-902, Poland

Location

Ambulatorium Sp. z o.o.

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Location

Centro Reumatologico Caguas

Caguas, 00725, Puerto Rico

Location

Latin Clinical Trial Center

San Juan, 00909, Puerto Rico

Location

GCM Medical Group, PSC - Hato Rey Site

San Juan, 00917, Puerto Rico

Location

Mindful Medical Research

San Juan, 00918, Puerto Rico

Location

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], 15006, Spain

Location

Clínica Gaias - Santiago

Santiago de Compostela, A Coruña [La Coruña], 15702, Spain

Location

Osi Bilbao-Basurto

Bilbao, Basque Country, 48013, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

CHUS - Hospital Clinico Universitario

Santiago de Compostela, Galicia [Galicia], 15706, Spain

Location

Hospital Quiron Infanta Luisa

Seville, 41010, Spain

Location

Related Links

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

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

08005455979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: August 31, 2022
• Primary Completion: November 20, 2023
• Study Completion: January 17, 2025
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: : Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (21); US (54); CN (9); PR (4); CA (3); HU (3); PL (10); ME (5); ES (6); GR (5); AR (11)