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Attivo ma non reclutanteFASE3INTERVENTISTICO

A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)

Vitiligo is a long-term condition where patches of skin lose their colour. Nonsegmental vitiligo is the most common form, usually causing pale patches on both sides of the body. This study, called STOP-V2, is testing an experimental medicine called povorcitinib to see if it can safely help restore skin colour. Researchers are comparing povorcitinib against a dummy tablet, known as a placebo, which contains no active medicine. The trial is open to adults aged 18 and older who have vitiligo patches on both their body and face. Volunteers will need to pause any other vitiligo treatments while taking part. Doctors will monitor their skin changes and overall health closely throughout regular clinic visits. The main goal is to determine whether povorcitinib is an effective and safe choice for people living with vitiligo.

A colpo d'occhio

Stato
Attivo ma non reclutante
Fase
FASE3
Sponsor
Incyte Corporation
Obiettivo di iscrizione
450
Inizio
27 Nov 2023
Completamento stimato
16 Mar 2027

Di cosa tratta questo studio?

Vitiligo happens when the immune system mistakenly attacks melanocytes, the cells that give skin its natural colour. This causes smooth, pale white patches to appear on different areas of the body. In nonsegmental vitiligo, these patches typically appear symmetrically on both sides, such as on both hands, knees, or across the face. While vitiligo is not painful or contagious, it can have an emotional and social impact on daily life, and current treatment options are limited.

The STOP-V2 study is investigating an experimental medicine called povorcitinib. Povorcitinib is designed to calm down specific immune signals that attack the skin's pigment cells. Researchers hope that by calming this immune response, the body will be able to restore natural colour to the affected patches.

This is a Phase 3 clinical study, which means the medicine has already passed earlier safety checks and is now being tested in a larger group of people. Half of the participants may receive povorcitinib, while others receive a placebo (an inactive tablet). This comparison is the standard way to prove whether the medicine truly works and what side effects it might cause.

Studies like this are vital for developing newer, more targeted treatments. By taking part, volunteers help doctors understand whether povorcitinib could become a widely available treatment for vitiligo in the UK and around the world.

Punti chiave

  • STOP-V2 is testing an experimental daily tablet called povorcitinib for nonsegmental vitiligo.
  • The study compares povorcitinib with an inactive dummy tablet (placebo).
  • Open to adults aged 18 and older with vitiligo patches on both their body and face.
  • Participants must pause all other vitiligo treatments during the study.
  • Taking part is voluntary, and you can withdraw at any time.

Chi può essere idoneo?

You may be able to take part if you are aged 18 or older and have a clinical diagnosis of nonsegmental vitiligo. Your pale patches must cover a certain amount of skin on both your body (at least 5%) and your face (at least 0.5%). You must also be willing to stop your current vitiligo therapies during the trial and agree to use effective contraception if you are able to have children.

You will not be eligible if you have other types of skin colour loss, have had surgery for vitiligo, or have used skin-bleaching treatments in the past. People who have had light therapy (phototherapy) within the last eight weeks or self-tanning products within the last four weeks are also unable to join right away.

For safety reasons, you cannot join if you are pregnant or breastfeeding, have serious heart problems, a history of blood clots, cancer, or long-term infections such as tuberculosis, hepatitis, or HIV. The study team will perform health checks and blood tests to make sure the trial is safe for you.

Questo studio potrebbe fare al caso tuo?

Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.

  1. I am aged 18 or older.
  2. I have been diagnosed with nonsegmental vitiligo.
  3. I have vitiligo patches on both my body and my face.
  4. I am willing to pause my current vitiligo creams and light therapy.
  5. I do not have a history of serious blood clots, heart disease, or chronic infections.
  6. I am not pregnant, planning a pregnancy, or breastfeeding.
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

Taking part involves taking a study tablet once a day. Because this is a blinded study, neither you nor your study doctor will know whether you are taking povorcitinib or a placebo dummy pill. You will need to stop all your usual vitiligo creams, light therapies, and other treatments during the trial.

You will attend regular clinic appointments over several months. During these visits, doctors will examine your skin patches, take photographs, check your vital signs, and carry out routine blood and urine tests. You will also be asked about your overall health and any symptoms you notice. The study team will explain the exact number of visits and the full duration of the trial before you agree to join.

Rischi e benefici potenziali

A potential benefit of taking part is that the study medicine might help bring colour back to your skin, although this cannot be guaranteed. You will also receive careful, regular medical care from skin specialists. However, there are risks, including possible medication side effects or the chance that your skin does not improve, especially if you receive the placebo. Pausing your regular treatments could also cause your vitiligo to change. Your participation is completely voluntary, and you are free to leave the trial at any point without it affecting your standard NHS care.

Locations (86)

  • University of Alabama At Birmingham Hospital-Whitaker Clinic
    Codice postale verificato
    Birmingham, Stati Uniti
  • C2 Research Center, Llc
    Codice postale verificato
    Montgomery, United States
  • First Oc Dermatology Research Inc
    Codice postale verificato
    Fountain Valley, United States
  • Center For Dermatology Clinical Research, Inc
    Codice postale verificato
    Fremont, United States
  • Marvel Clinical Research Llc
    Codice postale verificato
    Huntington Beach, Stati Uniti
  • Vitiligo & Pigmentation Institute of Southern California
    Codice postale verificato
    Los Angeles, Stati Uniti
  • Dermatology Research Associates
    Codice postale verificato
    Los Angeles, Stati Uniti
  • Clinical Trials Research Institute
    Codice postale verificato
    Thousand Oaks, Stati Uniti
  • Skin Care Research, Llc
    Codice postale verificato
    Boca Raton, United States
  • Total Vein and Skin Llc
    Codice postale verificato
    Boynton Beach, United States
  • Driven Research Llc
    Codice postale verificato
    Coral Gables, United States
  • Florida Academic Centers Research and Education Llc
    Codice postale verificato
    Coral Gables, United States

Domande comuni

What is nonsegmental vitiligo?

It is the most common form of vitiligo, where pale patches typically appear symmetrically on both sides of your body, such as both hands, elbows, or across the face.

Che cos'è un placebo?

A placebo is a dummy pill that looks identical to the real medicine but contains no active ingredients. It helps scientists see if the real drug actually works better than no treatment at all.

Will taking part cost me anything?

No, the study medication and all trial-related appointments and tests are provided free of charge. Many trials also help cover travel expenses.

Can I carry on using my vitiligo creams?

No. To make sure the trial results are clear, you will need to stop all current vitiligo treatments, including medicated creams and light therapy, while in the study.

Posso cambiare idea dopo essermi iscritto?

Yes. Taking part is entirely your choice. You can leave the study at any time, for any reason, without giving an explanation and without altering your regular medical care.

Come saperne di più

Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.

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