Clinical Trials in China / NCT07363590
Recruiting
Phase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
NCT07363590 · tracked via the Priya Life Science China tracker
Condition(s) studied
Systemic Lupus ErythematosusRheumatoid Arthritis
Study 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).
Eligibility
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, 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
Primary outcome measure(s)
- Part 1: Number of Participants with One or More Adverse Events (AEs) — Up to approximately 12 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. - Part 1: Number of Participants who Discontinue Study Drug Due to an AE — Up to approximately 4 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. - Part 2 and Part 3: Number of Participants with One or More AEs — Up to approximately 52 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. - Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE — Up to approximately 2 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Gold Coast University Hospital ( Site 1601) | Southport | Queensland | Recruiting |
| Anima Diepenbeek ( Site 0601) | Diepenbeek | Limburg | Recruiting |
| UZ Gent ( Site 0602) | Ghent | Oost-Vlaanderen | Recruiting |
| Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501) | Beijing | Beijing Municipality | Recruiting |
| The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502) | Luoyang | Henan | Recruiting |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504) | Wuhan | Hubei | Recruiting |
| Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505) | Shanghai | Shanghai Municipality | Recruiting |
| Clinica de la Costa S.A.S. ( Site 0101) | Barranquilla | Atlántico | Recruiting |
| Oncomédica S.A.S ( Site 0103) | Montería | Departamento de Córdoba | Recruiting |
| Fundacion Valle del Lili ( Site 0102) | Cali | Valle del Cauca Department | Recruiting |
| Arensia Exploartory Medicine ( Site 1301) | Tbilisi | Georgia | Recruiting |
| Istituto Clinico Humanitas- IRCCS ( Site 1902) | Rozzano | Milano | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901) | Roma | Italy | Recruiting |
| The University of Tokyo Hospital ( Site 0301) | Bunkyo | Tokyo | Active Not Recruiting |
| Keio University Hospital ( Site 0302) | Shinjyuku | Tokyo | Recruiting |
| PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001) | Chisinau | Moldova | Recruiting |
| Clinica San Juan Bautista ( Site 0203) | Lima | Peru | Recruiting |
| ARENSIA Clinics ( Site 0902) | Bucharest | Bucharest | Recruiting |
| ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901) | Cluj-Napoca | Cluj | Recruiting |
| Chulalongkorn University ( Site 0501) | Pathumwan | Bangkok | Recruiting |
| Ramathibodi Hospital ( Site 0503) | Ratchathewi | Bangkok | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07363590 on ClinicalTrials.gov ↗ ← All trials in China