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

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

Recruiting
18-75 years
All
Phase 1

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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).

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

Study details
    Systemic Lupus Erythematosus
    Rheumatoid Arthritis

NCT07363590

Merck Sharp & Dohme LLC

26 February 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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