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

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

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.

Study Overview

• Status: Terminated
• Conditions: Immune System Diseases; Autoimmune Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: Peresolimab

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Córdoba, Argentina, 5004
    • Hospital Cordoba
  • Córdoba, Argentina, X5000EDC
    • Instituto Médico Strusberg
  • San Juan, Argentina, 5400
    • Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1015
      • Organizacion Medica de Investigacion
    • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1417
      • Centro Privado de Medicina Familiar / Mindout Research
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1061AAS
      • CIPREC
    • CABA, Buenos Aires F.D., Argentina, 1406
      • APRILLUS Asistencia e Investigacion
  • Ciudad Autónoma de Buenos Aire
    • CABA, Ciudad Autónoma de Buenos Aire, Argentina, C1430EGF
      • Clinica Adventista Belgrano
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
      • Centro de Investigaciones Medicas Tucuman
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Centro de Investigaciones Reumatológicas
• Canada
  • Québec, Canada, G1V 3M7
    • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Limited
  • Quebec
    • Trois-Rivières, Quebec, Canada, G9A 3Y2
      • Centre de Recherche Musculo-Squelettique
• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Afflilated Hospital of Bengbu Medical College
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Shantou, Guangdong, China, 515041
      • The First Affiliated Hospital of Shantou University Medical College
    • Shenzhen, Guangdong, China, 518020
      • ShenZhen People's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical,Science & Technology
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Jiangxi
    • Pingxiang, Jiangxi, China, 337055
      • Jiangxi Pingxiang People's Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital Affiliated Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
• Greece
  • Attikí
    • Athens, Attikí, Greece, 115 27
      • General Hospital of Athens Hippokratio
    • Athens, Attikí, Greece, 11527
      • General Hospital of Athens Laiko
    • Chaïdári, Attikí, Greece, 12462
      • Attikon General University Hospital
  • Krítí
    • Heraklion, Krítí, Greece, 711 10
      • University General Hospital of Heraklion
  • Évros
    • Alexandroupoli, Évros, Greece, 68100
      • University Hospital of Alexandroupolis
• Hungary
  • Budapest, Hungary, 1036
    • Qualiclinic
  • Pest County
    • Budapest, Pest County, Hungary, 1027
      • Revita Clinic
  • Veszprém City
    • Veszprém, Veszprém City, Hungary, 8200
      • Vital Medical Center
• Japan
  • Chiba, Japan, 260-8712
    • National Hospital Organization Chibahigashi National Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hiroshima, Japan, 733-0032
    • Hiroshima Clinic
  • Kochi, Japan, 781-0112
    • Bayside Misato Medical Center
  • Nagano, Japan, 388-8004
    • Shinonoi General Hospital
  • Nagasaki, Japan, 850-0832
    • Nagasaki Internal Medicine- Rheumatology Hospital
  • Okayama, Japan, 700-8557
    • Okayama City General Medical Center Okayama City Hospital
  • Tokyo, Japan, 194-0023
    • Machida Municipal Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 455-8530
      • Chubu Rosai Hospital
    • Nagoya, Aichi-ken, Japan, 457-8511
      • Koujunkai Daido Clinic
  • Chiba
    • Urayasu, Chiba, Japan, 279-0021
      • Juntendo University Urayasu Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 807-8556
      • University of Occupational and Enviromental Health
    • Kitakyushu, Fukuoka, Japan, 803-0816
      • Shinkokura Hospital
    • Kitakyushu, Fukuoka, Japan, 804-0025
      • Tobata General Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0001
      • Sagawa Akira Rheumatology Clinic
    • Sapporo, Hokkaido, Japan, 060-0004
      • Tonan Hospital
  • Nagano
    • Sakaki, Nagano, Japan, 389-0606
      • Yoshida Internal Medicine Clinic
  • Nagasaki
    • Sasebo, Nagasaki, Japan, 857-1195
      • Sasebo Chuo Hospital
  • Niigata
    • Nagaoka, Niigata, Japan, 940-2108
      • Nagaoka Red Cross Hospital
  • Saitama
    • Tokorozawa, Saitama, Japan, 359-1111
      • Hirose Clinic - Tokorozawa
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
• Mexico
  • Chihuahua City, Mexico, 31000
    • Investigacion y Biomedicina de Chihuahua
  • Estado de Baja California
    • Mexicali, Estado de Baja California, Mexico, 21100
      • Centro Medico del Angel
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44650
      • Clinica de Investigacion en Reumatologia y Obesidad S. C.
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06700
      • Clinstile, S.A. de C.V.
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Kohler and Milstein Research S.A. de C.V.
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-113
      • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
    • Poznan, Greater Poland Voivodeship, Poland, 61-293
      • Twoja Przychodnia Poznanskie Centrum Medyczne
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
      • Szpital Uniwersytecki Nr 2 w Bydgoszczy
  • Lubusz Voivodeship
    • Nowa Sól, Lubusz Voivodeship, Poland, 67-100
      • Twoja Przychodnia NCM
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-665
      • Centrum Medyczne Reuma Park
    • Warsaw, Masovian Voivodeship, Poland, 00-874
      • MICS Centrum Medyczne Warszawa
    • Warsaw, Masovian Voivodeship, Poland, 02-118
      • Rheuma Medicus- Zak��ad Opieki Zdrowotnej
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-707
      • Nova Reuma Społka Partnerska
  • Silesian Voivodeship
    • Bytom, Silesian Voivodeship, Poland, 41-902
      • Nzoz Bif-Med
  • Warmian-Masurian Voivodeship
    • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
      • Ambulatorium sp. z o.o.
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Centro Reumatologico Caguas
  • San Juan, Puerto Rico, 00918
    • Mindful Medical Research
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group, PSC - Hato Rey Site
• Spain
  • Seville, Spain, 41010
    • Hospital Quiron Infanta Luisa
  • A Coruña [La Coruña]
    • A Coruña, A Coruña [La Coruña], Spain, 15006
      • CHUAC-Complejo Hospitalario Universitario A Coruña
    • Santiago de Compostela, A Coruña [La Coruña], Spain, 15702
      • Clínica Gaias - Santiago
  • Basque Country
    • Bilbao, Basque Country, Spain, 48013
      • Osi Bilbao-Basurto
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marqués de Valdecilla
  • Galicia [Galicia]
    • Santiago de Compostela, Galicia [Galicia], Spain, 15706
      • CHUS - Hospital Clinico Universitario
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Accel Research Sites - Birmingham Clinical Research Unit
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Arizona Arthritis & Rheumatology Research PLLC
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Mesa, Arizona, United States, 85210
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Phoenix, Arizona, United States, 85037
      • Arizona Arthritis & Rheumatology Associates, PLLC
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research - Metyas
    • Fullerton, California, United States, 92835
      • St Joseph Heritage Healthcare
    • Huntington Beach, California, United States, 92648
      • Newport Huntington Medical Group
    • Rancho Mirage, California, United States, 92270
      • Desert Medical Advances
    • Tujunga, California, United States, 91042
      • Dan La, MD Inc
    • Tustin, California, United States, 92780
      • Wolverine Clinical Trials
    • Whittier, California, United States, 90602
      • Medvin Clinical Research - Su
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic
    • Fort Collins, Colorado, United States, 80528
      • Tekton Research - Fort Collins - East Harmony Road
  • Florida
    • Avon Park, Florida, United States, 33825
      • HARAC Research Corp
    • Boynton Beach, Florida, United States, 33436
      • Encore Medical Research of Boynton Beach
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc. (Clearwater)
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • St. Petersburg, Florida, United States, 33705
      • BayCare Medical Group
    • Tamarac, Florida, United States, 33321
      • West Broward Rheumatology Associates
    • Tampa, Florida, United States, 33613
      • Forcare Clinical Research
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida
    • Tampa, Florida, United States, 33614
      • BayCare Medical Group
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials - Ravenswood
    • Hinsdale, Illinois, United States, 60521
      • Hinsdale Orthopaedics - llinois Bone & Joint Institute
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Accurate Clinical Research
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
    • Grand Blanc, Michigan, United States, 48439
      • AA Medical Research Center
    • Rochester Hills, Michigan, United States, 48307
      • Arthritis and Rheumatology Center of MI - Rochester Hills
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
    • St Louis, Missouri, United States, 63119
      • Saint Louis Rheumatology
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Arthritis & Osteoporosis Associates - Freehold
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Center for Rheumatology
  • New York
    • Brooklyn, New York, United States, 11201
      • Joseph S. and Diane H. Steinberg Ambulatory Care Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • DJL Clinical Research, PLLC
    • Leland, North Carolina, United States, 28451
      • Cape Fear Arthritis Care
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research & Consulting, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Piedmont Arthritis Clinic
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Management
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Houston, Texas, United States, 77043
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research
    • Houston, Texas, United States, 77089
      • Laila A Hassan, MD, PA
    • Houston, Texas, United States, 77084
      • Accurate Clinical Management - Houston
    • Tomball, Texas, United States, 77377
      • DM Clinical Research/Rheumatology Clinic of Houston
    • Tomball, Texas, United States, 77375
      • DM Clinical Research - Tomball
  • Washington
    • Bothell, Washington, United States, 98021
      • Sound Clinical Research, LLC
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest, PLLC
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Rheumatology & Pulmonary Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Peresolimab; Administered SC
Experimental: 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.	Drug: Peresolimab; Administered SC
Experimental: 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.	Drug: Peresolimab; Administered SC
Experimental: 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.	Drug: Peresolimab; Administered SC
Experimental: Peresolimab 100 mg SC Q4W; Participants received peresolimab 100 mg SC Q4W from Week 0 to Week 60.	Drug: Peresolimab; Administered SC
Experimental: 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.	Drug: Placebo; Administered SC; Drug: Peresolimab; Administered SC
Experimental: 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.	Drug: Placebo; Administered SC; Drug: Peresolimab; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 12	The ACR50 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR50 responders were participants with at least 50% improvement from baseline in TJC and SJC, and at least 50% 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, HAQ-DI which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100.	Week 12
Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70) Response at Week 12	The ACR70 response was a composite measure of clinical, laboratory, and functional assessments used to evaluate improvement in rheumatoid arthritis signs and symptoms. ACR70 responders were participants with at least 70% improvement from baseline in TJC and SJC, and at least 70% 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, HAQ-DI which measures participants' perceived degree of difficulty performing daily activities, and acute phase reactant as measured by hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100.	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	DAS28-hsCRP LDA was defined as DAS28-hsCRP score of ≤3.2. The Disease Activity Score (DAS) based on 28 joint counts consisted of a composite numerical score derived from the following variables: tender joint count (0 to 28), swollen joint count (0 to 28), high-sensitivity C-reactive protein (hsCRP, mg/mL), and the patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56*square root (sqrt) (TJC28) plus (+) 0.28*sqrt (SJC28)+ 0.014* participant's global assessment of disease activity+ 0.36*natural log(hsCRP+1) + 0.96. Total Scores ranged from 1.0 to 9.4, with lower scores indicating less disease activity.	Week 12
Percentage of Participants With Remission According to DAS28-hsCRP Score <2.6 at Week 12	DAS28-hsCRP remission is defined as DAS28-hsCRP <2.6. DAS based on 28 joints consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP=0.56*sqrt (TJC28) + 0.28*sqrt (SJC28) + 0.014* patient's global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Total Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.	Week 12
Percentage of Participants Achieving LDA According to Clinical Disease Activity Index (CDAI) Score ≤10 at Week 12	Low disease activity was defined as a CDAI score of ≤10. CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.	Week 12
Percentage of Participants Achieving Remission According to CDAI Score ≤2.8 at Week 12	Remission was defined as a CDAI score of ≤2.8. CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity.	Week 12
Change From Baseline in DAS28-hsCRP Score at Week 12	DAS based on 28 joints consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and patient's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP = 0.56*sqrt (TJC28) + 0.28*sqrt (SJC28)+ 0.014* patient's global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Total scores ranged 1.0-9.4; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition. Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) with treatment, stratification factors, baseline value, visit, treatment-by-visit interaction as fixed factors and participant as a random factor.	Baseline, Week 12
Change From Baseline in CDAI Score at Week 12	CDAI is a tool for measurement of disease activity in rheumatoid arthritis that does not require laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity(scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity).CDAI is calculated by summing values of 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. Negative change from baseline indicates improvement. LS Mean was calculated using MMRM with treatment, stratification factors, baseline value, visit, treatment-by-visit interaction as fixed factors and participant as a random factor.	Baseline, Week 12
Change From Baseline in HAQ-DI Score at Week 12	HAQ-DI was a patient-reported questionnaire used in rheumatoid arthritis to assess physical function over the past week. It covered 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Total score was computed as the sum of domain scores and divided by the number of domains answered. The total score ranges from 0 to 3, with higher scores indicating greater physical limitations. LS Mean was calculated using MMRM with treatment, stratification factors, baseline value, visit and treatment-by-visit interaction as fixed effects and participant as a random effect.	Baseline, Week 12
Minimum Observed Concentration of Peresolimab by Treatment-Emergent Anti-Drug Antibody (TE ADA) Status	Minimum observed concentration of peresolimab was assessed and stratified by Treatment-Emergent Anti-Drug Antibody (TE-ADA) status (TE ADA positive and TE ADA negative). A TE ADA evaluable participant was defined as TE ADA positive if they met the following criteria: Had baseline status of ADA Not Present and at least 1 postbaseline status of ADA Present with titer ≥ 2×minimum required dilution (MRD) of the ADA assay (Treatment Induced TE ADA). The MRD of peresolimab is 1:10.; Had baseline and postbaseline status of ADA Present, with the postbaseline titer being 2 dilutions (4-fold) greater than the baseline titer. TE-ADA negative participants were defined as those not meeting the TE ADA positive criteria.	Baseline through Week 12

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin and Connective Tissue Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Arthritis, Rheumatoid; Musculoskeletal Diseases; Immune System Diseases; Connective Tissue Diseases; Rheumatic Diseases
• Other Study ID Numbers: 18525; J1A-MC-KDAF (Other Identifier: Eli Lilly and Company); 2022-501425-20-00 (Other Identifier: EU Trial Number); U1111-1283-9566 (Other Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No