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

Official title

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

Overview

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).

Interventions

• Biological MK-1045
  IV infusion

Primary outcome measures

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

Secondary outcome measures (6)

• Part 1: Maximum Serum Concentration (Cmax) of MK-1045 [Time frame: 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 [Time frame: 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 [Time frame: At designated time points up to 12 weeks]
• Part 2 and Part 3: Cmax of MK-1045 [Time frame: 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 [Time frame: 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 [Time frame: At designated time points up to 52 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 3 centers

• Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501) — Beijing
• 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 — Wuhan

Colombia · 3 centers

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

Belgium · 2 centers

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

Italy · 2 centers

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

Japan · 2 centers

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

Romania · 2 centers

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

Thailand · 2 centers

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

Australia · 1 center

• Gold Coast University Hospital ( Site 1601) — Southport

Georgia · 1 center

• Arensia Exploartory Medicine ( Site 1301) — Tbilisi

Moldova · 1 center

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗