Clinical study of MK-6194 in adults with non-segmental vitiligo.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
- Adults aged 18 to 75 years, of any gender - Clinical diagnosis of non-segmental vitiligo, present for at least 6 months - At least a certain percentage of body and facial surfaces is affected by pigment loss caused by vitiligo. (BASEC)
Critères d'exclusion
- Presence of segmental vitiligo, ≥ 50% white hair (leukotrichia) on the face or body, or another dermatological or inflammatory disease that could affect the assessment of vitiligo. - Treatment with study-prohibited medications (e.g., recombinant IL-2, immunosuppressive therapies, etc.) and/or insufficient response to a prior treatment with JAK inhibitors after at least 12 weeks of treatment. - History of hypereosinophilic syndrome or eosinophilic disease such as eosinophilic lung disease including eosinophilic asthma, eosinophilic esophagitis, eosinophilic nephritis, or eosinophilic granulomatosis with polyangiitis. These diseases are characterized by an increased amount of a certain type of white blood cells, eosinophils, in the blood. (BASEC)
Lieu de l’étude
St-Gall, Zurich
(BASEC)
Sponsor
MSD Merck Sharp & Dohme AG, Lucerne
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Klaudia Georgi
+41 58 618 33 88
klaudia.georgi@cluttermsd.comMSD Merck Sharp & Dohme AG, Lucerne
(BASEC)
Informations générales
Merck Sharp & Dohme LLC
(ICTRP)
Informations scientifiques
Merck Sharp & Dohme LLC
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
19.12.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT06113328 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
MK-6194-007: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants with Non-Segmental Vitiligo (BASEC)
Titre académique
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Non-Segmental Vitiligo (ICTRP)
Titre public
A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007) (ICTRP)
Maladie en cours d'investigation
Non-segmental Vitiligo (ICTRP)
Intervention étudiée
Biological: MK-6194Drug: Placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Has a clinical diagnosis of non-segmental vitiligo
- Has non-segmental vitiligo with disease duration of at least 6 months
- Has depigmentation contributing to Facial Vitiligo Area Scoring Index (F-VASI) = 0.3
at screening and baseline
- Has depigmented facial body surface area (BSA) =0.3% at screening and baseline
- Has Total Vitiligo Area Scoring Index (T-VASI) =4 at screening and baseline
- Has total body vitiligo area =4% at screening and baseline excluding hands and feet
involvement
Exclusion Criteria:
- Has segmental vitiligo
- Has =50% leukotrichia on face or body
- Has any other dermatological diseases that would interfere with vitiligo assessments
- Has history of or current inflammatory condition other than vitiligo that, in the
opinion of the investigator, could interfere with the evaluation of vitiligo
- Has a known systemic hypersensitivity to interleukin 2 (IL-2), or modified IL-2
including MK-6194, or its inactive ingredients
- Has an active or clinically significant infection requiring hospitalization or
treatment with IV anti-infectives within 4 weeks prior to Randomization, or
oral/intramuscular anti-infective therapy within 2 weeks prior to Randomization
- 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 a transplanted organ, which requires continued immunosuppression
- Has a history of any malignancy, except for successfully treated non-melanoma skin
cancer or localized carcinoma in situ of the cervix
- Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB
- Has confirmed or suspected COVID-19 infection
- Has history of drug or alcohol abuse within 6 months prior to Screening
- Has had major surgery within 3 months prior to Screening OR has a major surgery
planned during the study
- Has had an inadequate response (as evaluated by a dermatologist or local physician
specialist equivalent) to previous treatment with a Janus kinase inhibitor (JAKi)
after an appropriate treatment duration (eg, =12 weeks)
- Has received prohibited medications within protocol-specified timeframes prior to
Randomization
- Has participated in another investigational clinical study within 4 weeks prior to
Randomization
- Has donated or lost =1 unit of blood (approximately 500 mL) within 4 weeks prior to
the Screening Visit
- Has received cosmetic or other procedures that could interfere with evaluation of
vitiligo during the study (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24;Number of Participants Who Experience an Adverse Event (AE);Number of Participants Who Discontinue Study Treatment Due to an AE (ICTRP)
Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24 (ICTRP)
Date d'enregistrement
27.10.2023 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Medical Director, Merck Sharp & Dohme LLC (ICTRP)
ID secondaires
2023-503502-37, U1111-1287-4329, MK-6194-007, jRCT2031230622, 6194-007 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06113328 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible