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A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)

RecruitingPhase 1Ages 18 Years - 75 YearsAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Has a body mass index between 18 and 32 kg/m\^2, inclusive * Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) 2019 classification criteria * SLE: Is taking at least one background therapy for SLE * RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA Exclusion Criteria: * Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing * History of serious recurrent or chronic infection * Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus * Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB * Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE * For RA participants, has a history of any arthritis with onset before age 17 years * Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments * History of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before Day 1 dosing * Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study. * Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening * Has a severe chronic pulmonary disease requiring oxygen therapy * Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease
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What it tests

  • MK-1045
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Where

21 sites
Gold Coast University Hospital ( Site 1601)
Southport, Australia
Anima Diepenbeek ( Site 0601)
Diepenbeek, Belgium
UZ Gent ( Site 0602)
Ghent, Belgium
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)
Beijing, China
The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502)
Luoyang, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)
Wuhan, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505)
Shanghai, China
Clinica de la Costa S.A.S. ( Site 0101)
Barranquilla, Colombia

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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