A Study of LY3462817 in Participants With Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).

Key facts

Study ID

NCT04634253

Run by

Eli Lilly and Company

People needed

98

Starts

2021-01-04

Expected to finish

2022-06-29

Last updated by the study team

2023-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening
• 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

You may not qualify if…

• Class IV RA according to ACR revised response 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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