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Clinical Trials in Italy / NCT07363590
Recruiting Phase 1

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

NCT07363590 · tracked via the Priya Life Science Italy tracker
Phase
Phase 1
Started
2026-02-19
Last updated
2026-09-14

Condition(s) studied

Systemic Lupus ErythematosusRheumatoid Arthritis

Investigational drug(s) / intervention(s)

MK-1045 →

MK-1045: IV infusion

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Gold Coast University Hospital ( Site 1601) Southport Queensland Recruiting
Anima Diepenbeek ( Site 0601) Diepenbeek Limburg Recruiting
UZ Gent ( Site 0602) Ghent Oost-Vlaanderen Recruiting
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501) Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502) Luoyang Henan Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504) Wuhan Hubei Recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505) Shanghai Shanghai Municipality Recruiting
Clinica de la Costa S.A.S. ( Site 0101) Barranquilla Atlántico Recruiting
Oncomédica S.A.S ( Site 0103) Montería Departamento de Córdoba Recruiting
Fundacion Valle del Lili ( Site 0102) Cali Valle del Cauca Department Recruiting
Arensia Exploartory Medicine ( Site 1301) Tbilisi Georgia Recruiting
Istituto Clinico Humanitas- IRCCS ( Site 1902) Rozzano Milano Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901) Roma Italy Recruiting
The University of Tokyo Hospital ( Site 0301) Bunkyo Tokyo Recruiting
Keio University Hospital ( Site 0302) Shinjyuku Tokyo Recruiting
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001) Chisinau Moldova Recruiting
Clinica San Juan Bautista ( Site 0203) Lima Peru Recruiting
ARENSIA Clinics ( Site 0902) Bucharest Bucharest Recruiting
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901) Cluj-Napoca Cluj Recruiting
Chulalongkorn University ( Site 0501) Pathumwan Bangkok Recruiting
Ramathibodi Hospital ( Site 0503) Ratchathewi Bangkok Recruiting

More Merck Sharp & Dohme LLC trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07363590 on ClinicalTrials.gov ↗ ← All trials in Italy