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NCT07363590RecruitingPhase 1

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

A Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
21 (estimated)
First submitted
16 Jan 2026
Start date
19 Feb 2026
Primary completion date
16 Jul 2029
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT07363590
EU CT number
2025-523412-36-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 21
  • From 19 Feb 2026 to the primary completion date, 16 Jul 2029
  • 24 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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
  • Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments
  • 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

Age

  • For RA participants, has a history of any arthritis with onset before age 17 years
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gold Coast University Hospital ( Site 1601)
Coordinator of this site? Confirm its status
SouthportAustraliaRecruiting
Anima Diepenbeek ( Site 0601)
Coordinator of this site? Confirm its status
DiepenbeekBelgiumRecruiting
UZ Gent ( Site 0602)
Coordinator of this site? Confirm its status
GhentBelgiumRecruiting
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502)
Coordinator of this site? Confirm its status
LuoyangChinaRecruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505)
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Clinica de la Costa S.A.S. ( Site 0101)
Coordinator of this site? Confirm its status
BarranquillaColombiaRecruiting
Fundacion Valle del Lili ( Site 0102)
Coordinator of this site? Confirm its status
CaliColombiaRecruiting
Oncomédica S.A.S ( Site 0103)
Coordinator of this site? Confirm its status
MonteríaColombiaRecruiting
Arensia Exploartory Medicine ( Site 1301)
Coordinator of this site? Confirm its status
TbilisiGeorgiaRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901)
Coordinator of this site? Confirm its status
RomaItalyRecruiting
Istituto Clinico Humanitas- IRCCS ( Site 1902)
Coordinator of this site? Confirm its status
RozzanoItalyRecruiting
The University of Tokyo Hospital ( Site 0301)
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BunkyoJapanActive, not recruiting
Keio University Hospital ( Site 0302)
Coordinator of this site? Confirm its status
ShinjyukuJapanRecruiting
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001)
Coordinator of this site? Confirm its status
ChisinauMoldovaRecruiting
Clinica San Juan Bautista ( Site 0203)
Coordinator of this site? Confirm its status
LimaPeruRecruiting
ARENSIA Clinics ( Site 0902)
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BucharestRomaniaRecruiting
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901)
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaRecruiting
Chulalongkorn University ( Site 0501)
Coordinator of this site? Confirm its status
PathumwanThailandRecruiting
Ramathibodi Hospital ( Site 0503)
Coordinator of this site? Confirm its status
RatchathewiThailandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.