Clinical study of MK-6194 in adults with non-segmental vitiligo.

Zusammenfassung der Studie

This study evaluates the efficacy and safety of MK-6194 compared to a placebo. A placebo looks visually like the drug under investigation, but contains no active ingredient. The main objective of this study is to examine the efficacy of MK-6194, compared to the placebo, using a vitiligo point index. This is used to determine the extent and severity of depigmentation. Additionally, the safety and tolerability of MK-6194 will be assessed by observing side effects occurring during the study. The participants in this study will be adults with non-segmental vitiligo that has been present for at least 6 months and leads to depigmented skin on the face and the rest of the body. The diagnosis must have been made by a qualified physician. Autoimmune and inflammatory diseases result from inappropriate immune activity. MK-6194 resembles an endogenous protein that is responsible for activating certain immune system cells (regulatory T cells). Once activated, these cells dampen inflammatory processes. Since non-segmental vitiligo is very likely an autoimmune disease, patients with non-segmental vitiligo may benefit from therapy with MK-6194. MK-6194 is being tested in various studies for the treatment of different diseases, including ulcerative colitis, atopic eczema, and vitiligo. However, MK-6194 is not yet approved for any indication. MK-6194 and the placebo will be administered as an injection under the skin. Approximately 165 patients aged 18 to 75 years are expected to participate in this study worldwide. The study will be conducted over a period of approximately 28 months, with about 16 planned clinical visits.

(BASEC)

Untersuchte Intervention

After a maximum 1-month screening phase, each participating individual will be randomly assigned to treatment with either MK-6194 alone, alternating MK-6194 and placebo, or placebo only. The treatment duration may last up to 13 months. A follow-up will occur about one month after the last dose and will consist of a phone call.

After thorough information, precise eligibility assessment, and collection of medical history, the participant will be included in the study and randomly assigned in a 1:1:1 ratio to one of the following groups:

Group 1: Participants receive only MK-6194

Group 2: Participants receive alternating MK-6194 and a placebo

Group 3: Participants receive a placebo for the first 24 weeks, after which they will be assigned to either Group 1 or 2. Participants have the same chance of being assigned to either of the two groups.

Neither the study physician nor the participants know which group they are assigned to and thus whether MK-6194 and/or the placebo is administered (known as double-blind). In case of an emergency, it can be determined which group a participant is in.

MK-6194 and the placebo will be administered alternately every two weeks at the center or as a subcutaneous injection. The study staff will train participants on how to inject the study medications into an abdominal fold. They will also explain how to keep a diary to document the use of the medication.

As part of study appointments, various measures and examinations may occur, such as: electrocardiogram (ECG), blood and urine tests, chest X-ray, photographs of affected and unaffected areas, assessment of general health status, and discussions with medical personnel. The study team may also contact participants between visits and after the completion of the study medication intake to inquire about their health status.

About one month after the last dose of the study medication, patients will be called for a follow-up.

(BASEC)

Untersuchte Krankheit(en)

Vitiligo is an acquired, chronic inflammatory skin depigmentation disorder that leads to the development of milky-white spots (macules) on the skin. Vitiligo is a widespread condition, affecting about 1% of the global population. Adults and children, regardless of gender, are equally affected. Vitiligo occurs in two main forms, referred to as non-segmental and segmental vitiligo. The non-segmental form is the most common and is being studied in this trial. Non-segmental vitiligo can occur at any age. However, in 70-80% of patients, the disease occurs before the age of 30. The course of the disease is unpredictable and can vary from almost no increase to very active phases. Vitiligo itself does not affect life expectancy, but due to the color differences of the skin, the disease can have a significant impact on the mental health of patients. The disease also progresses in irregular flares, which can cause additional stress for patients. The exact causes of vitiligo are complex and not yet fully understood. However, it is believed that various factors play a role. The most significant hypothesis explains the loss of melanocytes (loss of cells that produce skin pigment) as a consequence of an immune disorder. This hypothesis is supported by the increased occurrence of vitiligo alongside other autoimmune diseases, such as thyroid diseases, type 1 diabetes, or rheumatoid arthritis. Currently, there is an approved treatment method for non-segmental vitiligo in some countries: JAK inhibitors, which are applied topically to the affected areas and show significant repigmentation. However, they are not approved for vitiligo in Switzerland. Other treatment approaches include steroids, calcineurin inhibitors, and phototherapy. All these treatment approaches have side effects or other impacts on the patient, which is why there is still a great need for safe and well-tolerated treatment options.

(BASEC)

Sponsor

MSD Merck Sharp & Dohme AG, Lucerne

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

19.12.2023

(BASEC)

Ergebnisse der Studie