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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
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)
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.
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