A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Recruiting · NCT07363590 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
MK-1045
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
21 locations listed.
- PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001) - Chisinau, Moldova
- Clinica San Juan Bautista ( Site 0203) - Lima, Peru
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901) - Roma, Italy
- Arensia Exploartory Medicine ( Site 1301) - Tbilisi, Georgia
- Clinica de la Costa S.A.S. ( Site 0101) - Barranquilla, Atlántico, Colombia
- Chulalongkorn University ( Site 0501) - Pathumwan, Bangkok, Thailand
- Ramathibodi Hospital ( Site 0503) - Ratchathewi, Bangkok, Thailand
- Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501) - Beijing, Beijing Municipality, China
- ARENSIA Clinics ( Site 0902) - Bucharest, Bucharest, Romania
- ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901) - Cluj-Napoca, Cluj, Romania
- Oncomédica S.A.S ( Site 0103) - Montería, Departamento de Córdoba, Colombia
- The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502) - Luoyang, Henan, China
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504) - Wuhan, Hubei, China
- Anima Diepenbeek ( Site 0601) - Diepenbeek, Limburg, Belgium
- Istituto Clinico Humanitas- IRCCS ( Site 1902) - Rozzano, Milano, Italy
- UZ Gent ( Site 0602) - Ghent, Oost-Vlaanderen, Belgium
- Gold Coast University Hospital ( Site 1601) - Southport, Queensland, Australia
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505) - Shanghai, Shanghai Municipality, China
- The University of Tokyo Hospital ( Site 0301) - Bunkyo, Tokyo, Japan
- Keio University Hospital ( Site 0302) - Shinjyuku, Tokyo, Japan
- Fundacion Valle del Lili ( Site 0102) - Cali, Valle del Cauca Department, Colombia