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

Merck Sharp & Dohme (MSD)

Status and phase: Begins enrollment this month; Phase 1

Conditions: Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Biological: MK-1045

Study type: Interventional

Funder types: Industry

Identifiers

NCT07363590

MK-1045-004 (Other Identifier)

2025-523412-36-00 (Registry Identifier)

U1111-1326-4816 (Registry Identifier)

1045-004

Details and patient eligibility

About

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).

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Part 1 Prime Dose Escalation Panels

Experimental group

Description:

Participants will receive single intravenous (IV) doses of MK-1045 at varying dose levels.

Treatment:

Biological: MK-1045

Part 2 Step-up Dose Escalation Panels

Experimental group

Description:

Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.

Treatment:

Biological: MK-1045

Part 3 Dose Expansion Panels (Optional)

Experimental group

Description:

Participants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.

Treatment:

Biological: MK-1045