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Study on MK-6194 for Adults with Systemic Lupus Erythematosus

Verified siteInvestigational

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease where the body's immune system mistakenly attacks healthy tissue. The treatment being tested is called MK-6194, which is administered as a solution for injection. The study will compare the effects of MK-6194 to a placebo to determine its effectiveness and safety in treating SLE.

The purpose of the study is to evaluate how well MK-6194 works in reducing the symptoms of SLE and to assess its safety for patients. Participants in the study will receive either MK-6194 or a placebo and will be monitored over a period of time to observe any changes in their condition. The study will last for a total of 104 weeks, with key assessments taking place at weeks 28 and 52. During this time, researchers will look at various indicators of disease activity and any side effects experienced by participants.

Throughout the study, participants will be closely observed to ensure their safety and to gather data on how MK-6194 affects their SLE symptoms. The study aims to provide valuable information on whether MK-6194 can be a beneficial treatment option for people living with SLE, potentially improving their quality of life by managing the disease more effectively.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be randomly assigned to receive either the investigational medication MK-6194 or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.
Step 2
Treatment administration
The treatment involves receiving a solution for injection under the skin (subcutaneous injection). The specific dosage and frequency of administration will be determined by the study protocol and communicated to the participant at the start of the trial.
Step 3
Monitoring and assessments
Throughout the study, the participant will undergo regular assessments to monitor the effectiveness and safety of the treatment. These assessments will include evaluations of the participant's response to the treatment and any potential side effects.
The primary goal is to assess the proportion of participants achieving a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 28. Additional assessments will be conducted at Week 52.
Step 4
Completion of the study
The study is expected to conclude by July 2027. Upon completion, participants will have contributed valuable data to evaluate the efficacy and safety of MK-6194 for the treatment of systemic lupus erythematosus.

Who can join the trial?

7 criteria

The patient must have been diagnosed with **Systemic Lupus Erythematosus (SLE)** for at least 6 months before the screening.
The patient should be taking at least one ongoing treatment for SLE. This could be an **immunosuppressant** (a medicine that reduces the activity of the immune system), **dapsone** (a medication used to treat skin conditions), an **antimalarial** (a drug used to prevent or treat malaria), or **oral corticosteroids** (medicines that reduce inflammation).
The patient must have a positive test for **antinuclear antibody (ANA)** with a titer of at least 1:80, or a positive test for **anti-double-strand deoxyribonucleic acid (dsDNA) antibody**, **anti-Sm antibody**, or **anti-SSA/Ro antibody**. These are specific blood tests that help confirm the presence of SLE.
The patient should have at least one of the following signs of SLE: An active lupus rash with a **CLASI-A erythema and scale/hypertrophy combined score** greater than 2, or more than 2 tender and swollen joints in the wrists, **metacarpophalangeals (MCPs)** (joints in the hand), or **proximal interphalangeals (PIPs)** (joints in the fingers).
The patient must have a **hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)** total score of at least 6 and a clinical hybrid SLEDAI score of at least 4. This is a way to measure the activity or severity of the disease.
The study is open to both male and female patients.
The study includes patients from vulnerable populations, which means it considers those who might need special attention or care.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures.
Patients with a known allergy to the study medication.
Patients with certain infections that are not well controlled.
Patients who have had a recent major surgery.
Patients with a history of certain types of cancer.
Patients who are taking medications that might interfere with the study.

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Verified sites

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Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Verified
Naples, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy

Trial locations

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Investigated drugs

MK-6194 is an investigational medication being studied for its potential to treat systemic lupus erythematosus, a chronic autoimmune disease. The trial aims to assess how effective MK-6194 is in improving the symptoms of lupus and to evaluate its safety and tolerability in adult participants.

Mk-6194

What is already known about the treatment

MK-6194 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating Systemic Lupus Erythematosus, an autoimmune disease. It is in the experimental phase and not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication is to reduce symptoms and improve the quality of life for patients with this condition. MK-6194 works by modulating the immune system at the molecular level, aiming to decrease inflammation and autoantibody production. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Systemic Lupus Erythematosus – Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. SLE is characterized by periods of illness, called flares, and periods of wellness, or remission. The severity and progression of symptoms can vary widely among individuals. Over time, SLE can lead to damage in the affected organs and tissues.