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

NCT07363590

RecruitingPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Systemic Lupus Erythematosus, Rheumatoid Arthritis

Interventions: MK-1045

Countries: Australia, Belgium, China, Colombia, Georgia, Italy, Japan, Moldova

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (18)
  • Southport, Queensland, Australia
  • Diepenbeek, Limburg, Belgium
  • Ghent, Oost-Vlaanderen, Belgium
  • Beijing, Beijing Municipality, China
  • Luoyang, Henan, China
  • Wuhan, Hubei, China
  • Barranquilla, Atlántico, Colombia
  • Montería, Departamento de Córdoba, Colombia
  • Cali, Valle del Cauca Department, Colombia
  • Tbilisi, Georgia
  • Rozzano, Milano, Italy
  • Roma, Italy
  • Bunkyo, Tokyo, Japan
  • Shinjyuku, Tokyo, Japan
  • Chisinau, Moldova
  • Bucharest, Bucharest, Romania
  • Cluj-Napoca, Cluj, Romania
  • Pathumwan, Bangkok, Thailand