MK-6194 in Adult Participants with Non-Segmental Vitiligo

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1008311

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Vitiligo is a condition in which there is loss of skin pigment to areas of the body. Vitiligo can be classified into 2 major forms, segmental and non-segmental vitiligo (most common). While vitiligo has no impact on life expectancy, it has a great impact on the psychosocial aspect of affected patients’ life and mental wellbeing. All available treatment options come either with a serious warning in their label and/or a high patient burden so there remains a high unmet need for safe treatment options.

  This trial is testing MK-6194 compared to placebo in adults with non-segmented vitiligo. MK-6194 is experimental and has not been approved.

  This trial is being done to:
  • Test the safety of MK-6194
  • See how well MK-6194 works compared to placebo

  This trial has 3 phases: Screening, Treatment phase (Double-Blind Treatment and Blinded Extension) and Follow-up. Participants will be in the trial for about 1 year.

  The screening phase will see if participants can join the trial and will last up to 1 month.

  Eligible participants will be randomised in a 1:1:1 ratio to:
  • Group 1: Participant will get MK-6194 only.
  • Group 2: Participants will alternate between getting MK-6194 and placebo.
  • Group 3: Participants will get placebo for the first 24 weeks. After this time, they will be moved into Group 1 or 2. Participants will have an equal chance of being moved to either group.

  MK-6194 and placebo will be self-administered as a subcutaneous (SC) injection. MK-6194 or placebo will be pre-filled into a syringe. All participants will get the SC injection every 2 weeks for up to 52 weeks.

  During the trial, participants will undergo procedures such as physical examinations, answer questionnaires, have photographs taken of their face and body, and blood samples. After the participants stop getting the trial drug, they will enter the follow-up phase (a phone call a month after the last dose of the trial drug).

• REC name

  London - Brent Research Ethics Committee

• REC reference

  23/LO/0802

• Date of REC Opinion

  1 Nov 2023

• REC opinion

  Further Information Favourable Opinion