🏛️ Verified NIH Record • Updated 2026-08-27

A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) (NCT07363590)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (13 items).

Location: Gold Coast University Hospital ( Site 1601) — Southport, Queensland

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (20 Sites)

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

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗