A Study of LY3462817 in Participants With Rheumatoid Arthritis
NCT ID: NCT04634253
Last Updated: 2023-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2021-01-04
2022-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LY3462817 300 mg
Participants received Intravenous (IV) infusion of 300 mg LY3462817 solution.
LY3462817
Given IV
LY3462817 700 mg
Participants received IV infusion of 700 mg LY3462817 solution.
LY3462817
Given IV
Placebo
Participants received IV infusion of 0.9% sodium chloride solution (Placebo).
Placebo
Given IV
Interventions
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Placebo
Given IV
LY3462817
Given IV
Eligibility Criteria
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Inclusion Criteria
* Have moderately to severely active RA defined by the presence of ≥6 swollen joints (based on 66 joint count) and ≥6 tender joints (based on 68 joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility
* Have at least 1 of the following:
* positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at screening, OR
* previous radiographs documenting bony erosions in hands or feet consistent with RA
* Have C-reactive protein (CRP) \>1.2 times upper limit of normal (ULN) per the central laboratory at screening
* Demonstrated an inadequate response to, or loss of response or intolerance to:
* at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment OR
* at least 1 biologic DMARD/tsDMARD treatment
Exclusion Criteria
* Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of:
* basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
* cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline
* Have presence of confirmed cervical dysplasia
* Have had various types of infection within 3 months of screening or develops any of these infections before the randomization visit.
* Have any of the following:
* Human immunodeficiency virus (HIV) infection
* Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction (PCR) positive for HBV DNA
* Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)
* Active tuberculosis (TB)
* Have failed more than 2 biologic DMARDs (bDMARDs) or tsDMARDs (e.g. excluded if have received 2 bDMARDs and 1 tsDMARD)
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P. C.
Phoenix, Arizona, United States
Desert Medical Advances
Palm Desert, California, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Medical Plus
Uherské Hradiště, Zlín, Czechia
PV Medical Services s.r.o.
Zlín, , Czechia
CRU Hungary Kft.
Miskolc, Borsod-Abauj Zemplen county, Hungary
Revita Clinic
Budapest, Pest County, Hungary
Vital Medical Center
Veszprém, Veszprém City, Hungary
Budai Irgalmasrendi Korhaz
Budapest, , Hungary
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
Budapest, , Hungary
Centro Medico del Angel
Mexicali, Estado de Baja California, Mexico
Centro de Estudios de Investigacion Basica y Clinica, S.C.
Guadalajara, Jalisco, Mexico
RM Pharma Specialists S.A. de C.V.
Mexico City, Mexico City, Mexico
Köhler & Milstein Research
Mérida, Yucatán, Mexico
Investigacion y Biomedicina de Chihuahua
Chihuahua City, , Mexico
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, Poland
Reumatika - Centrum Reumatologii
Warsaw, Masovian Voivodeship, Poland
Nzoz Bif-Med
Bytom, Silesian Voivodeship, Poland
Centro Reumatologico Caguas
Caguas, , Puerto Rico
Latin Clinical Trial Center
San Juan, , Puerto Rico
Royal Free Hospital
Barnet, , United Kingdom
Countries
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References
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Tuttle J, Emery P, Nirula A. Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. Reply. N Engl J Med. 2023 Jul 27;389(4):378-379. doi: 10.1056/NEJMc2307020. No abstract available.
Tuttle J, Drescher E, Simon-Campos JA, Emery P, Greenwald M, Kivitz A, Rha H, Yachi P, Kiley C, Nirula A. A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis. N Engl J Med. 2023 May 18;388(20):1853-1862. doi: 10.1056/NEJMoa2209856.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3462817 in Participants With Rheumatoid Arthritis
Other Identifiers
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J1A-MC-KDAD
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002673-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17424
Identifier Type: -
Identifier Source: org_study_id
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