Rheumatoid ArthritisPhase 2RESOLUTION-1NCT05516758
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
A Phase 2 study testing Peresolimab in people with Rheumatoid Arthritis and Arthritis, run by Eli Lilly and Company at 131 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Arthritis, Joint Diseases
- What is being tested?
- Peresolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 491 participants
- Where
- 131 sitesin 11 countries
- Study dates
- 31 Aug 2022to 17 Jan 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
131 sites in 11 countries.
131 sites in 11 countries
United States54 sites
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Tekton Research, Inc
Austin, Texas, 78745
HARAC Research Corp
Avon Park, Florida, 33825
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Accurate Clinical Management
Baytown, Texas, 77521
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, 25801
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216
Sound Clinical Research, LLC
Bothell, Washington, 98021
Encore Medical Research of Boynton Beach
Boynton Beach, Florida, 33436
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 11201
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28211
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
Medvin Clinical Research - Metyas
Covina, California, 91722
Metroplex Clinical Research Center
Dallas, Texas, 75231
Denver Arthritis Clinic
Denver, Colorado, 80230
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Tekton Research - Fort Collins - East Harmony Road
Fort Collins, Colorado, 80528
Arthritis & Osteoporosis Associates - Freehold
Freehold, New Jersey, 07728
St Joseph Heritage Healthcare
Fullerton, California, 92835
Arizona Arthritis & Rheumatology Research PLLC
Gilbert, Arizona, 85297
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306
AA Medical Research Center
Grand Blanc, Michigan, 48439
Piedmont Arthritis Clinic
Greenville, South Carolina, 29601
Hinsdale Orthopaedics - llinois Bone & Joint Institute
Hinsdale, Illinois, 60521
Biopharma Informatic, LLC
Houston, Texas, 77043
Accurate Clinical Management - Houston
Houston, Texas, 77084
Biopharma Informatic, LLC
Houston, Texas, 77084
Accurate Clinical Research
Houston, Texas, 77089
Laila A Hassan, MD, PA
Houston, Texas, 77089
Newport Huntington Medical Group
Huntington Beach, California, 92648
Accurate Clinical Research
Lake Charles, Louisiana, 70605
Cape Fear Arthritis Care
Leland, North Carolina, 28451
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, 85210
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103
Arizona Arthritis & Rheumatology Associates, PLLC
Phoenix, Arizona, 85037
Desert Medical Advances
Rancho Mirage, California, 92270
Arthritis and Rheumatology Center of MI - Rochester Hills
Rochester Hills, Michigan, 48307
Arthritis Northwest, PLLC
Spokane, Washington, 99204
Clinvest Research LLC
Springfield, Missouri, 65807
Saint Louis Rheumatology
St Louis, Missouri, 63119
Baycare Medical Group
St. Petersburg, Florida, 33705
West Broward Rheumatology Associates
Tamarac, Florida, 33321
Clinical Research of West Florida
Tampa, Florida, 33606
ForCare Clinical Research
Tampa, Florida, 33613
Baycare Medical Group
Tampa, Florida, 33614
DM Clinical Research - Tomball
Tomball, Texas, 77375
DM Clinical Research/Rheumatology Clinic of Houston
Tomball, Texas, 77377
Dan La, MD Inc
Tujunga, California, 91042
Wolverine Clinical Trials
Tustin, California, 92780
Medvin Clinical Research - Su
Whittier, California, 90602
Japan21 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
National Hospital Organization Chibahigashi National Hospital
Chiba, 260-8712
Hiroshima Clinic
Hiroshima, 733-0032
Hiroshima University Hospital
Hiroshima, 734-8551
Shinkokura Hospital
Kitakyushu, Fukuoka, 803-0816
Tobata General Hospital
Kitakyushu, Fukuoka, 804-0025
University of Occupational and Enviromental Health
Kitakyushu, Fukuoka, 807-8556
Bayside Misato Medical Center
Kochi, 781-0112
Shinonoi General Hospital
Nagano, 388-8004
Nagaoka Red Cross Hospital
Nagaoka, Niigata, 940-2108
Nagasaki Internal Medicine- Rheumatology Hospital
Nagasaki, 850-0832
Chubu Rosai Hospital
Nagoya, Aichi-ken, 455-8530
Koujunkai Daido Clinic
Nagoya, Aichi-ken, 457-8511
Okayama City General Medical Center Okayama City Hospital
Okayama, 700-8557
Yoshida Internal Medicine Clinic
Sakaki, Nagano, 389-0606
Sagawa Akira Rheumatology Clinic
Sapporo, Hokkaido, 060-0001
Tonan Hospital
Sapporo, Hokkaido, 060-0004
Sasebo Chuo Hospital
Sasebo, Nagasaki, 857-1195
Hirose Clinic - Tokorozawa
Tokorozawa, Saitama, 359-1111
Machida Municipal Hospital
Tokyo, 194-0023
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021
Argentina11 sites
CIPREC
Buenos Aires, Buenos Aires F.D., C1061AAS
Fundación Respirar
Buenos Aires, C1426ABP
Organizacion Medica de Investigacion
CABA, Buenos Aires, C1015
APRILLUS Asistencia E Investigacion
CABA, Buenos Aires F.D., 1406
Clinica Adventista Belgrano
CABA, Ciudad Autónoma de Buenos Aire, C1430EGF
Centro Privado de Medicina Familiar / Mindout Research
Ciudad Autónoma de Buenos Aire, Buenos Aires, 1417
Hospital Córdoba
Córdoba, 5004
Instituto Medico Strusberg
Córdoba, X5000EDC
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan, 5400
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, 4000
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucumán, Tucumán Province, T4000AXL
Poland10 sites
Nova Reuma Społka Partnerska
Bialystok, Podlaskie Voivodeship, 15-707
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
Nzoz Bif-Med
Bytom, Silesian Voivodeship, 41-902
Ambulatorium Sp. z o.o.
Elblag, Warmian-Masurian Voivodeship, 82-300
Twoja Przychodnia NCM
Nowa Sól, Lubusz Voivodeship, 67-100
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, Greater Poland Voivodeship, 61-113
Twoja Przychodnia Poznanskie Centrum Medyczne
Poznan, Greater Poland Voivodeship, 61-293
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship, 00-874
Rheuma Medicus- Zak��ad Opieki Zdrowotnej
Warsaw, Masovian Voivodeship, 02-118
Centrum Medyczne Reuma Park
Warsaw, Masovian Voivodeship, 02-665
China9 sites
Afflilated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Xiangya Hospital Central South University
Changsha, Hunan, 410008
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Huashan Hospital Affiliated Fudan University
Shanghai, Shanghai Municipality, 200040
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
ShenZhen People's Hospital
Shenzhen, Guangdong, 518020
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei, 430030
Spain6 sites
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006
Osi Bilbao-Basurto
Bilbao, Basque Country, 48013
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Clínica Gaias - Santiago
Santiago de Compostela, A Coruña [La Coruña], 15702
CHUS - Hospital Clinico Universitario
Santiago de Compostela, Galicia [Galicia], 15706
Hospital Quiron Infanta Luisa
Seville, 41010
Greece5 sites
University Hospital of Alexandroupolis
Alexandroupoli, Évros, 68100
General Hospital of Athens Hippokratio
Athens, Attikí, 115 27
General Hospital of Athens Laiko
Athens, Attikí, 11527
Attikon General University Hospital
Chaïdári, Attikí, 12462
University General Hospital of Heraklion
Heraklion, Krítí, 711 10
Mexico5 sites
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, 44650
Kohler and Milstein Research S.A. de C.V.
Mérida, Yucatán, 97070
Centro Medico del Angel
Mexicali, Estado de Baja California, 21100
Clinstile, S.A. de C.V.
Mexico City, Mexico City, 06700
Puerto Rico4 sites
Centro Reumatologico Caguas
Caguas, 00725
Latin Clinical Trial Center
San Juan, 00909
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917
Mindful Medical Research
San Juan, 00918
Canada3 sites
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, G1V 3M7
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G9A 3Y2
Hungary3 sites
Revita Clinic
Budapest, Pest County, 1027
Qualiclinic
Budapest, 1036
Vital Medical Center
Veszprém, Veszprém City, 8200
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases
- Being tested
- Peresolimab, Placebo
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeresolimabDrug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Peresolimab |
| Peresolimab 100 mg SC Q4W | Experimental | Participants received peresolimab 100 mg SC Q4W from Week 0 to Week 60. Receives: 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. Receives: 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. Receives: Drug: Peresolimab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start31 Aug 2022
- Primary completion20 Nov 2023
- Study completion17 Jan 2025
Why it stopped: Study terminated due to an unfavourable benefit-risk profile observed in interim data analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516758
- Sponsor's protocol ID
- 18525
- Other IDs
- J1A-MC-KDAF, 2022-501425-20-00, U1111-1283-9566
- Acronym
- RESOLUTION-1
- Status last verified
- Nov 2025
- First submitted
- 24 Aug 2022
- Last updated
- 4 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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