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

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called MK-1045 in people with either systemic lupus erythematosus (SLE) — an autoimmune disease where the immune system attacks the body — or rheumatoid arthritis (RA), a condition causing painful joint inflammation. **You may be eligible if...** - You have been diagnosed with SLE for at least 6 months and are currently on at least one SLE medication, OR - You have been diagnosed with rheumatoid arthritis for at least 6 months - Your body mass index (BMI) is between 18 and 32 **You may NOT be eligible if...** - You have an active infection currently requiring treatment - You have a history of serious repeated infections - You are infected with hepatitis B, hepatitis C, or HIV - You have a history of certain cancers or serious immune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMK-1045

IV infusion

Locations(15)

Gold Coast University Hospital ( Site 1601)

Southport, Queensland, Australia

Anima Diepenbeek ( Site 0601)

Diepenbeek, Limburg, Belgium

UZ Gent ( Site 0602)

Ghent, Oost-Vlaanderen, Belgium

Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)

Beijing, Beijing Municipality, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)

Wuhan, Hubei, China

Clinica de la Costa S.A.S. ( Site 0101)

Barranquilla, Atlántico, Colombia

Oncomédica S.A.S ( Site 0103)

Montería, Departamento de Córdoba, Colombia

Fundacion Valle del Lili ( Site 0102)

Cali, Valle del Cauca Department, Colombia

Arensia Exploartory Medicine ( Site 1301)

Tbilisi, Georgia

Istituto Clinico Humanitas- IRCCS ( Site 1902)

Rozzano, Milano, Italy

The University of Tokyo Hospital ( Site 0301)

Bunkyo, Tokyo, Japan

Keio University Hospital ( Site 0302)

Shinjyuku, Tokyo, Japan

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

Chisinau, Moldova

ARENSIA Clinics ( Site 0902)

Bucharest, Bucharest, Romania

ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901)

Cluj-Napoca, Cluj, Romania

View Full Details on ClinicalTrials.gov

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NCT07363590

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