Testing MK-1045 Safety in People With Lupus or Rheumatoid Arthritis
Tests a study medicine, MK-1045, at different doses in adults with lupus or arthritis.
Plain-language title generated from the registry record
Registry title: A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Key facts
- Where
- Diepenbeek and Gent, BelgiumSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07363590, who can take part
Where in Belgium
- AnimaDiepenbeek, BelgiumTaking people
- Universitair Ziekenhuis GentGent, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07363590EU 2025-523412-36-00
- Record updated
- 2 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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; 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; 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.