Phase 2 Vitiligo Trial, Terminated NCT06113328 Sponsor: Merck Sharp & Dohme LLC Condition: Vitiligo
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT06113328) tested an investigational medicine called MK-6194 in people with vitiligo — a skin condition where patches of skin lose their colour. A total of 169 participants took part in the initial double-blind phase, split into three groups: 57 received MK-6194 by injection every two weeks (Q2W), 55 received it every four weeks (Q4W), and 57 received a placebo (a dummy treatment with no active ingredient). Those who completed that phase could continue into an extension period. The trial was primarily measuring changes in the extent of skin colour loss on the face and across the whole body, as well as tracking any unwanted medical events (called adverse events) that occurred during the study. The reported data shows that after 24 weeks, the facial skin colour loss score (called F-VASI — a scale where a lower score means less affected skin) changed by an average of −4.55% in the every-two-weeks MK-6194 group, −12.13% in the every-four-weeks group, and −4.01% in the placebo group. For the whole-body score (T-VASI), the reported changes were −1.69%, −9.08%, and +0.78% respectively — meaning the placebo group's score nudged slightly upward (suggesting a small increase in skin involvement on average). Regarding unwanted medical events, the reported data shows that 51 out of 57 participants in the every-two-weeks group, 47 out of 55 in the every-four-weeks group, and 44 out of 57 in the placebo group experienced at least one adverse event. The number of participants who stopped treatment because of an adverse event was 9, 5, and 1 in those same groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Vitiligo Trial, Terminated

NCT06113328
Terminated Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with non-segmental vitiligo (the most common type, where patches appear on both sides of the body)
  • You have had non-segmental vitiligo for at least 6 months
  • The loss of skin color on your face meets a minimum level of severity based on a standard scoring tool called F-VASI (score of 0.3 or higher)
  • At least 0.3% of the skin surface on your face has lost its color
  • The overall loss of skin color across your body meets a minimum level of severity based on a standard scoring tool called T-VASI (score of 4 or higher)
  • At least 4% of your total body skin has lost its color, not counting the hands and feet

Who may not be able to join:

  • You have segmental vitiligo (the type that appears only on one side or part of the body)
  • More than half of the hairs on your face or body have turned white or lost their color
  • You have another skin condition that would make it hard to assess your vitiligo
  • You have a current or past inflammatory condition (other than vitiligo) that could affect how the study evaluates your skin (confirm with trial site)
  • You have a known allergy or serious reaction to the study drug or similar medicines
  • You have had an active or significant infection recently — needing hospital treatment or IV antibiotics in the past 4 weeks, or oral/injected antibiotics in the past 2 weeks
  • You have significant heart failure, a heart attack, or unstable chest pain within the past 6 months
  • You have a serious long-term lung disease that requires you to use supplemental oxygen
  • You have received an organ transplant and still take medicines to prevent rejection
  • You have a history of cancer, except for certain treated skin cancers or a localized form of cervical pre-cancer
  • You have active, latent, or inadequately treated tuberculosis (TB)
  • You have a confirmed or suspected current COVID-19 infection
  • You have had problems with drug or alcohol misuse within the past 6 months
  • You have had major surgery in the past 3 months, or have major surgery planned during the study period
  • A dermatologist has determined that you did not respond well enough to a previous treatment with a type of medicine called a JAK inhibitor, after taking it for at least 12 weeks
  • You have taken certain medications that are not allowed by the study within specific timeframes before joining (confirm with trial site)
  • You have taken part in another clinical trial within the past 4 weeks
  • You have donated or lost about 500 mL (one unit) of blood in the past 4 weeks
  • You have had cosmetic treatments or procedures that could affect how the study measures your vitiligo

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Australian sites

Paratus Clinical Research Woden ( Site 1703), Phillip, Australian Capital Territory
Westmead Hospital-Dermatology ( Site 1701), Westmead, New South Wales
Skin Health Institute Inc.-Trials ( Site 1702), Carlton, Victoria
Sinclair Dermatology ( Site 1704), Melbourne, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
27 November 2023
Est. completion
20 March 2025

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percent Change From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24; Number of Participants Who Experienced an Adverse Event (AE); Number of Participants Who Discontinued Study Treatment Due to an AE

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov