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

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

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

Conditions4

Interventions1

Related trials

• A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002) — MSD R&D (China) Co., Ltd.
• A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008) — Merck Sharp & Dohme LLC
• A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) — Merck Sharp & Dohme LLC
• A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101) — MSD R&D (China) Co., Ltd.

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