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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
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29
21
Participants Needed
12
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a study medicine called MK-1045 in adults with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The study focuses on understanding how people respond to different dose levels of MK-1045. This research is sponsored by Merck Sharp & Dohme LLC and is designed as a Phase 1 clinical trial to assess safety and how the drug behaves in the body over time. Participants will receive MK-1045 through intravenous (IV) infusions. The dosing plan includes single intravenous doses at varying levels, as well as a series of three step-up doses over a three-week period, progressing from a prime dose to a target dose. The study is randomized, with participants assigned to different dosing panels to evaluate safety and drug behavior at each stage. During the study, participants will be monitored for side effects, including any adverse events and the reasons for stopping the study drug. Blood tests will measure how much MK-1045 is in the body and the effect on B cell counts at various times up to 52 weeks. Safety and drug effects are carefully tracked with follow-ups lasting up to approximately one year. Overall participation may last for several months, depending on the study part.
CONDITIONS
Brief 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...
- Has a body mass index between 18 and 32 kg/m^2, inclusive
- Has a diagnosis of systemic lupus erythematosus (SLE) for at least 6 months and meets the 2019 EULAR/ACR classification criteria
- Is taking at least one background therapy for SLE
- Has a diagnosis of rheumatoid arthritis (RA) for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA
- Aged between 18 and 75 years
You will not qualify if you...
- Has a known active infection (excluding fungal infection of nail beds) or any major infection requiring hospitalization or anti-infective treatment within 8 weeks prior to dosing
- History of serious recurrent or chronic infection
- Known 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
- History of arthritis onset before age 17 for RA participants
- Current inflammatory conditions other than SLE or RA that could affect disease assessments
- History of cancer except certain treated skin or cervical cancers and disease free for less than 5 years
- Major surgery within 3 months prior to screening or planned during the study
- Symptomatic heart failure (NYHA class III or IV), recent heart attack, or unstable angina within 6 months prior to screening
- Severe chronic lung disease requiring oxygen therapy
- Current active or suspected lymphoproliferative disease including lymphoma or related symptoms
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 52 weeks
Participants receive intravenous (IV) doses of MK-1045 at varying dose levels or step-up doses over a 3-week dosing interval depending on the study part.
Multiple visits for dosing and assessments over the treatment period
Trial Site Locations
Total: 12 locations
1
Gold Coast University Hospital ( Site 1601)
Southport, Queensland, Australia, 4215
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2
Anima Diepenbeek ( Site 0601)
Diepenbeek, Limburg, Belgium, 3590
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3
UZ Gent ( Site 0602)
Ghent, Oost-Vlaanderen, Belgium, 9000
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4
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)
Beijing, Beijing Municipality, China, 100005
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5
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)
Wuhan, Hubei, China, 430058
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6
Arensia Exploartory Medicine ( Site 1301)
Tbilisi, Georgia, 0112
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7
Istituto Clinico Humanitas- IRCCS ( Site 1902)
Rozzano, Milano, Italy, 20089
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8
The University of Tokyo Hospital ( Site 0301)
Bunkyo, Tokyo, Japan, 113-8655
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9
Keio University Hospital ( Site 0302)
Shinjyuku, Tokyo, Japan, 160-8582
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10
PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001)
Chisinau, Moldova, 2025
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11
ARENSIA Clinics ( Site 0902)
Bucharest, Bucharest, Romania, 011658
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12
ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901)
Cluj-Napoca, Cluj, Romania, 400006
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Research Team
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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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