Status:
RECRUITING
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 whe...
Eligibility Criteria
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
- 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
- Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease
Key Trial Info
Start Date :
February 19 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 16 2029
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT07363590
Start Date
February 19 2026
End Date
July 16 2029
Last Update
March 9 2026
Active Locations (3)
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1
Anima Diepenbeek ( Site 0601)
Diepenbeek, Limburg, Belgium, 3590
2
Arensia Exploartory Medicine ( Site 1301)
Tbilisi, Georgia, 0112
3
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001)
Chisinau, Moldova, 2025