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

NCT ID: NCT07363590
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 21 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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

Study locations

21 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Australia, Belgium, China, Colombia, Georgia, Italy, Japan, Moldova, Peru, Romania, Thailand

Queensland, Australia: 1
Limburg, Belgium: 1
Oost-Vlaanderen, Belgium: 1
Beijing Municipality, China: 1
Henan, China: 1
Hubei, China: 1
Shanghai Municipality, China: 1
Atlántico, Colombia: 1
Departamento de Córdoba, Colombia: 1
Valle del Cauca Department, Colombia: 1
Milano, Italy: 1
Tokyo, Japan: 2
Bucharest, Romania: 1
Cluj, Romania: 1
Bangkok, Thailand: 2

Sample of listed locations

Gold Coast University Hospital ( Site 1601) — Southport, Queensland, 4215, Australia — Site recruitment status not specified in the registry data
Anima Diepenbeek ( Site 0601) — Diepenbeek, Limburg, 3590, Belgium — Site recruitment status not specified in the registry data
UZ Gent ( Site 0602) — Ghent, Oost-Vlaanderen, 9000, Belgium — Site recruitment status not specified in the registry data
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501) — Beijing, Beijing Municipality, 100005, China — Site recruitment status not specified in the registry data
The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502) — Luoyang, Henan, 471003, China — Site recruitment status not specified in the registry data
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504) — Wuhan, Hubei, 430058, China — Site recruitment status not specified in the registry data
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505) — Shanghai, Shanghai Municipality, 200001, China — Site recruitment status not specified in the registry data
Clinica de la Costa S.A.S. ( Site 0101) — Barranquilla, Atlántico, 080020, Colombia — Site recruitment status not specified in the registry data
Oncomédica S.A.S ( Site 0103) — Montería, Departamento de Córdoba, 230002, Colombia — Site recruitment status not specified in the registry data
Fundacion Valle del Lili ( Site 0102) — Cali, Valle del Cauca Department, 760032, Colombia — Site recruitment status not specified in the registry data
Arensia Exploartory Medicine ( Site 1301) — Tbilisi, 0112, Georgia — Site recruitment status not specified in the registry data
Istituto Clinico Humanitas- IRCCS ( Site 1902) — Rozzano, Milano, 20089, Italy — Site recruitment status not specified in the registry data
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901) — Roma, 00168, Italy — Site recruitment status not specified in the registry data
The University of Tokyo Hospital ( Site 0301) — Bunkyo, Tokyo, 113-8655, Japan — Site recruitment status not specified in the registry data
Keio University Hospital ( Site 0302) — Shinjyuku, Tokyo, 160-8582, Japan — Site recruitment status not specified in the registry data
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001) — Chisinau, 2025, Moldova — Site recruitment status not specified in the registry data
Clinica San Juan Bautista ( Site 0203) — Lima, 15419, Peru — Site recruitment status not specified in the registry data
ARENSIA Clinics ( Site 0902) — Bucharest, Bucharest, 011658, Romania — Site recruitment status not specified in the registry data
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901) — Cluj-Napoca, Cluj, 400006, Romania — Site recruitment status not specified in the registry data
Chulalongkorn University ( Site 0501) — Pathumwan, Bangkok, 10330, Thailand — Site recruitment status not specified in the registry data
Ramathibodi Hospital ( Site 0503) — Ratchathewi, Bangkok, 10400, Thailand — Site recruitment status not specified in the registry data

Study details

Start date: February 19, 2026
Primary completion date: July 16, 2029
First posted: January 23, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07363590
Registry last updated: September 14, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07363590 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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