RecruitingPhase 1NCT07363590

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

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

Sponsor

Merck Sharp & Dohme LLC

Enrollment

21 participants

Start Date

Feb 19, 2026

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis Systemic Lupus Erythematosus

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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 Criteria12

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