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Evaluation of Safety and Tolerability of MK-1045 in Lupus and Rheumatoid Arthritis Patients

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What is being tested

MK-1045

Biological
Who is being recruted

Arthritis+7

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

From 18 to 75 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 27, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on a medication named MK-1045, which is being tested in individuals with lupus and rheumatoid arthritis (RA). The primary aim of this study is to understand the safety of MK-1045 and how well it is tolerated by participants when given in different doses. The importance of this study lies in its potential to uncover a new treatment option for these conditions, which could help improve patient care and address current treatment challenges. During this trial, participants will receive MK-1045 in varying doses. The study measures the results by tracking the number of participants who experience unfavorable effects known as Adverse Events (AEs). These AEs could be any unfavorable sign, symptom, disease, or worsening of an existing condition that occurs during the study, regardless of whether it's directly caused by the treatment. The study also records the number of participants who discontinue the study drug due to an AE. This information helps researchers evaluate the safety and tolerability of MK-1045.

Official TitleA Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis
NCT07363590
Principal SponsorMerck Sharp & Dohme LLC
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesLupus Erythematosus, SystemicMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue Diseases

Criteria

4 inclusion criteria required to participate
RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA
SLE: Is taking at least one background therapy for SLE
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
12 exclusion criteria prevent from participating
Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE
Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study.
Has a severe chronic pulmonary disease requiring oxygen therapy
Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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