Actively Recruiting
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-04
21
Participants Needed
8
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index between 18 and 32 kg/m^2, inclusive
- Diagnosis of systemic lupus erythematosus (SLE) for at least 6 months meeting EULAR/ACR 2019 criteria
- Taking at least one background therapy for SLE
- Diagnosis of rheumatoid arthritis (RA) for at least 6 months meeting 2010 ACR-EULAR criteria
You will not qualify if you...
- Known active infection or major infection requiring hospitalization or treatment within 8 weeks prior to Day 1 dosing
- History of serious recurrent or chronic infection
- Infection with hepatitis B, hepatitis C, or HIV
- Evidence of active, latent, or inadequately treated tuberculosis
- Significant or uncontrolled medical disease unrelated to RA or SLE
- RA diagnosed before age 17 years
- Current inflammatory condition other than SLE or RA interfering with disease activity assessment
- History of cancer within 5 years except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after surgical removal
- Major surgery within 3 months before screening or planned during the study
- Symptomatic heart failure (NYHA class III or IV), recent myocardial infarction, or unstable angina within 6 months before screening
- Severe chronic lung disease requiring oxygen therapy
- Active lymphoproliferative disease or signs suggesting it
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Anima Diepenbeek ( Site 0601)
Diepenbeek, Limburg, Belgium, 3590
Actively Recruiting
2
Arensia Exploartory Medicine ( Site 1301)
Tbilisi, Georgia, 0112
Actively Recruiting
3
Istituto Clinico Humanitas- IRCCS ( Site 1902)
Rozzano, Milano, Italy, 20089
Actively Recruiting
4
The University of Tokyo Hospital ( Site 0301)
Bunkyo, Tokyo, Japan, 113-8655
Actively Recruiting
5
Keio University Hospital ( Site 0302)
Shinjyuku, Tokyo, Japan, 160-8582
Actively Recruiting
6
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001)
Chisinau, Moldova, 2025
Actively Recruiting
7
ARENSIA Clinics ( Site 0902)
Bucharest, Bucharest, Romania, 011658
Actively Recruiting
8
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901)
Cluj-Napoca, Cluj, Romania, 400006
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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