> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-peresolimab-ly3462817-in-participants-with-0dbaefe8-15e1-45f3-962f-1647df769ef8 > Record changed: 2026-10-13 # A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis NCT05516758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) Recruitment status Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) Participants 491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) Start date 2022-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) Number of sites 131 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Acronym** RESOLUTION-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Short title** A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Official title** A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Status and phase **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Recruitment status** Terminated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Reason stopped** Study terminated due to an unfavourable benefit-risk profile observed in interim data analysis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Dates **Completion date** 2025-01-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **First posted** 2022-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Registry last updated** 2025-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Primary completion date** 2023-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Start date** 2022-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Size and sites **Actual participants** 491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Participants** 491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Number of sites** 131 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Identifiers **Registry ID** NCT05516758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **ClinicalTrials.gov ID** NCT05516758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Outcomes ### Primary outcomes 1. Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) Response at Week 12 Timeframe: 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. ### Secondary outcomes 1. Percentage of Participants Achieving 50% Improvement in American College of Rheumatology Criteria (ACR50) Response at Week 12 Timeframe: 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. 2. Percentage of Participants Achieving 70% Improvement in American College of Rheumatology Criteria (ACR70) Response at Week 12 Timeframe: 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. 3. 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 Timeframe: 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. 4. Percentage of Participants With Remission According to DAS28-hsCRP Score <2.6 at Week 12 Timeframe: 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. 5. Percentage of Participants Achieving LDA According to Clinical Disease Activity Index (CDAI) Score ≤10 at Week 12 Timeframe: 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. 6. Percentage of Participants Achieving Remission According to CDAI Score ≤2.8 at Week 12 Timeframe: 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. 7. Change From Baseline in DAS28-hsCRP Score at Week 12 Timeframe: Baseline, 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. 8. Change From Baseline in CDAI Score at Week 12 Timeframe: Baseline, 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. 9. Change From Baseline in HAQ-DI Score at Week 12 Timeframe: Baseline, 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. 10. Minimum Observed Concentration of Peresolimab by Treatment-Emergent Anti-Drug Antibody (TE ADA) Status Timeframe: Baseline through Week 12 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: 1\. 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\. 2\. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Sites - Accel Research Sites - Birmingham Clinical Research UnitBirmingham, United States - Arizona Arthritis & Rheumatology Research PLLCGilbert, United States - Arizona Arthritis & Rheumatology Research, PLLCGlendale, United States - Arizona Arthritis & Rheumatology Research, PLLCMesa, United States - Arizona Arthritis & Rheumatology Associates, PLLCPhoenix, United States - Medvin Clinical Research - MetyasCovina, United States - St Joseph Heritage HealthcareFullerton, United States - Newport Huntington Medical GroupHuntington Beach, United States - Desert Medical AdvancesRancho Mirage, United States - Dan La, MD IncTujunga, United States - Wolverine Clinical TrialsTustin, United States - Medvin Clinical Research - SuWhittier, United States - Denver Arthritis ClinicDenver, United States - Tekton Research - Fort Collins - East Harmony RoadFort Collins, United States - HARAC Research CorpAvon Park, United States - Encore Medical Research of Boynton BeachBoynton Beach, United States - Clinical Research of West Florida, Inc. (Clearwater)Clearwater, United States - Suncoast Clinical Research, Inc.New Port Richey, United States - Baycare Medical GroupSt. Petersburg, United States - West Broward Rheumatology AssociatesTamarac, United States - Clinical Research of West FloridaTampa, United States - ForCare Clinical ResearchTampa, United States - Baycare Medical GroupTampa, United States - Great Lakes Clinical Trials - RavenswoodChicago, United States - Hinsdale Orthopaedics - llinois Bone & Joint InstituteHinsdale, United States And 106 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/356796) ### Other registry identifiers (3) - 2022-501425-20-00 - J1A-MC-KDAF - U1111-1283-9566 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05516758) ## Related records ### Drugs (1) - [Peresolimab](https://trialight.com/data/asset/peresolimab-b6de4252-e07c-47e4-b1a0-b81657648fef.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (7) - [Arthritic joint disease](https://trialight.com/data/condition/arthritic-joint-disease-594ede40-773b-5c20-afc1-eb18dabbe039.md) - [Arthropathy](https://trialight.com/data/condition/arthropathy-bbc05db6-678e-5b8c-abde-9076b91012cc.md) - [Autoimmune disease](https://trialight.com/data/condition/autoimmune-disease-8a8fd8aa-2d04-5f24-b839-ba96a70c11e9.md) - [Connective tissue disorder](https://trialight.com/data/condition/connective-tissue-disorder-3df54ecd-c080-5b4c-b60d-fab4846ea17b.md) - [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md) - [Rheumatic disorder](https://trialight.com/data/condition/rheumatic-disorder-e863530e-2c28-5a33-b1be-d12fa4d746b9.md) - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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