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
- Tbilisi, GeorgiaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA) to test a study medicine, MK-1045, at different doses.
- Age
- 18 to 75 years
- Sex
- All sexes can join
- Disease stage
- SLE or RA diagnosed for at least 6 months, meeting the 2019 EULAR/ACR criteria (SLE) or the 2010 ACR-EULAR criteria (RA)
- Earlier treatment
- People with SLE must be taking at least one background therapy for SLE.
Main reasons for not taking part
- Known active infection, or a major infection needing hospital or anti-infective treatment within 8 weeks before Day 1 dosing
- Hepatitis B, hepatitis C or HIV infection
- Active, latent or inadequately treated tuberculosis (TB)
- Cancer history, unless disease free for 5 years or more (some skin and cervical cancers excepted)
- Symptomatic heart failure (NYHA class III or IV), or heart attack or unstable angina within 6 months before Screening
Read by machine on 9 November 2026.
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 Georgia
- Arensia Exploartory Medicine (Site 1301)Tbilisi, GeorgiaTaking 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.