A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
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).
| Condition(s) | Systemic Lupus Erythematosus, Rheumatoid Arthritis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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 participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Locations | Southport, Queensland, Australia; Diepenbeek, Limburg, Belgium; Ghent, Oost-Vlaanderen, Belgium; Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Barranquilla, Atlántico, Colombia (+9 more sites) |
| Start date | 2026-02-19 |
| NCT ID | NCT07363590 |
| Official listing | https://clinicaltrials.gov/study/NCT07363590 |