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New treatment option for Systemic Lupus Erythematosus
Official title A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
ClinicalTrials.gov ID: NCT07363590
What this study is testing
What is MK-1045?
MK-1045 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as CN201.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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
You likely can't join if
- Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Southport, Queensland, Australia
- Diepenbeek, Limburg, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Beijing, Beijing Municipality, China
- Luoyang, Henan, China
- Wuhan, Hubei, China
- Barranquilla, Atlántico, Colombia
- Montería, Departamento de Córdoba, Colombia
- Cali, Valle del Cauca Department, Colombia
- Tbilisi, Georgia
- Rozzano, Milano, Italy
- Roma, Italy
- Bunkyo, Tokyo, Japan
- Shinjyuku, Tokyo, Japan
- Chisinau, Moldova
- Bucharest, Bucharest, Romania
- Cluj-Napoca, Cluj, Romania
- Pathumwan, Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Southport, Queensland, Australia; Diepenbeek, Limburg, Belgium; Ghent, Oost-Vlaanderen, Belgium; Beijing, Beijing Municipality, China; Luoyang, Henan, China; Wuhan, Hubei, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.