Study on MK-6194 for Adults with Systemic Lupus Erythematosus

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hospital Universitario Rio Hortega	Valladolid	Spain
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.	Cracow	Poland
Reumed Sp. z o.o.	Lublin	Poland
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.	Bialystok	Poland
Azienda Ospedaliera di Padova	Padua	Italy
Hospital Quirón Salud Infanta Luisa	Sevilla	Spain
Medyczne Centrum Hetmanska	Poznan	Poland
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Centre Hospitalier Saint Joseph Saint Luc	Lyon	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hospital General Universitario De Valencia	Valencia	Spain
NIEPUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ BIF-MED S.C. A. Wawiernia,M. Roykiewicz,R. Roykiewicz	Bytom	Poland
Mzllxbamx Ihvryyrnpp Chumsqof Sdnksmmq Spn z ougg	Warsaw	Poland
Aodbgrh Onsdndwpnab Ueqylvfqunlnq Spwbmo	Siena	Italy
Inzlpmyu dd Cmhvyqijzunn Hpbsqznfwju Uvcfctkgewrak dz Skwzy Epnqsqp (gplxuap	Saint Priest En Jarez	France
Hbzlhnbq Vaqu dbmzjemz	Barcelona	Spain
Htkcelks Utmamuohdpefh dh A Clggto	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	11.03.2024
Italy	Not recruiting	11.03.2024
Poland	Not recruiting	11.03.2024
Spain	Not recruiting	11.03.2024

Trial locations

Investigated drugs:

Mk-6194

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.

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.

Trial ID:

2023-505520-61-00

Protocol code:

MK-6194-006

Trial Phase:

Therapeutic use (Phase IV)

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Study on MK-6194 for Adults with Systemic Lupus Erythematosus

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