MK-1045 for people with lupus or rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, interventional, dose-ranging trial sponsored by Merck that gives MK-1045 to adults with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA) to determine safety and tolerability. Participants receive MK-1045 at different dose levels and are monitored for adverse events, infections, and laboratory changes. Eligible participants must have had SLE or RA for at least six months, meet standard classification criteria, and have a body mass index between 18 and 32 kg/m^2. People with active infections, hepatitis B or C, HIV, tuberculosis, or significant uncontrolled medical conditions are excluded.

Why it matters

Who can join: the full rules

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

Where it's running

• Gold Coast University Hospital ( Site 1601)
  Southport, Queensland, Australia Recruiting
• Anima Diepenbeek ( Site 0601)
  Diepenbeek, Limburg, Belgium Recruiting
• UZ Gent ( Site 0602)
  Ghent, Oost-Vlaanderen, Belgium Recruiting
• Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502)
  Luoyang, Henan, China Recruiting
• Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.