NCT07363590RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 16 Jan 2026
- Start date
- 19 Feb 2026
- Primary completion date
- 16 Jul 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Lupus (SLE), Rheumatoid arthritis
- NCT number
- NCT07363590
- EU CT number
- 2025-523412-36-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 21
- From 19 Feb 2026 to the primary completion date, 16 Jul 2029
- 24 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Age
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gold Coast University Hospital ( Site 1601) Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Anima Diepenbeek ( Site 0601) Coordinator of this site? Confirm its status | Diepenbeek | Belgium | Recruiting |
| UZ Gent ( Site 0602) Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501) Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502) Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505) Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504) Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Clinica de la Costa S.A.S. ( Site 0101) Coordinator of this site? Confirm its status | Barranquilla | Colombia | Recruiting |
| Fundacion Valle del Lili ( Site 0102) Coordinator of this site? Confirm its status | Cali | Colombia | Recruiting |
| Oncomédica S.A.S ( Site 0103) Coordinator of this site? Confirm its status | Montería | Colombia | Recruiting |
| Arensia Exploartory Medicine ( Site 1301) Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901) Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Istituto Clinico Humanitas- IRCCS ( Site 1902) Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| The University of Tokyo Hospital ( Site 0301) Coordinator of this site? Confirm its status | Bunkyo | Japan | Active, not recruiting |
| Keio University Hospital ( Site 0302) Coordinator of this site? Confirm its status | Shinjyuku | Japan | Recruiting |
| PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001) Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| Clinica San Juan Bautista ( Site 0203) Coordinator of this site? Confirm its status | Lima | Peru | Recruiting |
| ARENSIA Clinics ( Site 0902) Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901) Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Chulalongkorn University ( Site 0501) Coordinator of this site? Confirm its status | Pathumwan | Thailand | Recruiting |
| Ramathibodi Hospital ( Site 0503) Coordinator of this site? Confirm its status | Ratchathewi | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.