A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)

Официальное название

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

Обзор

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).

Вмешательства

• Биопрепарат MK-1045
  IV infusion

Первичные конечные точки

• Part 1: Number of Participants with One or More Adverse Events (AEs) [Срок оценки: Up to approximately 12 weeks]
• Part 1: Number of Participants who Discontinue Study Drug Due to an AE [Срок оценки: Up to approximately 4 weeks]
• Part 2 and Part 3: Number of Participants with One or More AEs [Срок оценки: Up to approximately 52 weeks]
• Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE [Срок оценки: Up to approximately 2 weeks]

Вторичные конечные точки (6)

• Part 1: Maximum Serum Concentration (Cmax) of MK-1045 [Срок оценки: At designated time points up to 12 weeks]
• Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1045 [Срок оценки: At designated time points up to 12 weeks]
• Part 1: Percentage of Participants with a Peripheral B Cell Count Less Than the Lower Limit of Quantitation (LLOQ) at the End of Each Treatment Period [Срок оценки: At designated time points up to 12 weeks]
• Part 2 and Part 3: Cmax of MK-1045 [Срок оценки: At designated time points up to 52 weeks]
• Part 2 and Part 3: Area Under the Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) of MK-1045 [Срок оценки: At designated time points up to 52 weeks]
• Part 2 and Part 3: Percentage of Participants with a Peripheral B Cell Count Less Than the LLOQ at the End of the Treatment Period [Срок оценки: At designated time points up to 52 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501) — Пекин
• The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502) — Luoyang
• Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site — Ухань

Колумбия · 3 центра

• Clinica de la Costa S.A.S. ( Site 0101) — Barranquilla
• Oncomédica S.A.S ( Site 0103) — Montería
• Fundacion Valle del Lili ( Site 0102) — Cali

Бельгия · 2 центра

• Anima Diepenbeek ( Site 0601) — Diepenbeek
• UZ Gent ( Site 0602) — Ghent

Италия · 2 центра

• Istituto Clinico Humanitas- IRCCS ( Site 1902) — Rozzano
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma

Япония · 2 центра

• The University of Tokyo Hospital ( Site 0301) — Bunkyo
• Keio University Hospital ( Site 0302) — Shinjyuku

Румыния · 2 центра

• ARENSIA Clinics ( Site 0902) — Bucharest
• ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901) — Cluj-Napoca

Таиланд · 2 центра

• Chulalongkorn University ( Site 0501) — Pathumwan
• Ramathibodi Hospital ( Site 0503) — Ratchathewi

Австралия · 1 центр

• Gold Coast University Hospital ( Site 1601) — Southport

Грузия · 1 центр

• Arensia Exploartory Medicine ( Site 1301) — Tbilisi

Moldova · 1 центр

• PMSI Republican Clinical Hospital "T.Mosneaga" ( Site 1001) — Chisinau

Идентификаторы

NCT: NCT07363590 · 1045-004 · U1111-1326-4816 · 2025-523412-36-00 · MK-1045-004 · jRCT2031250748

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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