Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07363590

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-04

21

Participants Needed

8

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index between 18 and 32 kg/m^2, inclusive
  • Diagnosis of systemic lupus erythematosus (SLE) for at least 6 months meeting EULAR/ACR 2019 criteria
  • Taking at least one background therapy for SLE
  • Diagnosis of rheumatoid arthritis (RA) for at least 6 months meeting 2010 ACR-EULAR criteria
Not Eligible

You will not qualify if you...

  • Known active infection or major infection requiring hospitalization or treatment within 8 weeks prior to Day 1 dosing
  • History of serious recurrent or chronic infection
  • Infection with hepatitis B, hepatitis C, or HIV
  • Evidence of active, latent, or inadequately treated tuberculosis
  • Significant or uncontrolled medical disease unrelated to RA or SLE
  • RA diagnosed before age 17 years
  • Current inflammatory condition other than SLE or RA interfering with disease activity assessment
  • History of cancer within 5 years except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after surgical removal
  • Major surgery within 3 months before screening or planned during the study
  • Symptomatic heart failure (NYHA class III or IV), recent myocardial infarction, or unstable angina within 6 months before screening
  • Severe chronic lung disease requiring oxygen therapy
  • Active lymphoproliferative disease or signs suggesting it

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Anima Diepenbeek ( Site 0601)

Diepenbeek, Limburg, Belgium, 3590

Actively Recruiting

2

Arensia Exploartory Medicine ( Site 1301)

Tbilisi, Georgia, 0112

Actively Recruiting

3

Istituto Clinico Humanitas- IRCCS ( Site 1902)

Rozzano, Milano, Italy, 20089

Actively Recruiting

4

The University of Tokyo Hospital ( Site 0301)

Bunkyo, Tokyo, Japan, 113-8655

Actively Recruiting

5

Keio University Hospital ( Site 0302)

Shinjyuku, Tokyo, Japan, 160-8582

Actively Recruiting

6

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

Chisinau, Moldova, 2025

Actively Recruiting

7

ARENSIA Clinics ( Site 0902)

Bucharest, Bucharest, Romania, 011658

Actively Recruiting

8

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

Cluj-Napoca, Cluj, Romania, 400006

Actively Recruiting

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Research Team

T

Toll Free Number

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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