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

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(4)

Anima Diepenbeek ( Site 0601)

Diepenbeek, Limburg, Belgium

Arensia Exploartory Medicine ( Site 1301)

Tbilisi, Georgia

Istituto Clinico Humanitas- IRCCS ( Site 1902)

Rozzano, Milano, Italy

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

Chisinau, Moldova

View Full Details on ClinicalTrials.gov

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NCT07363590


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