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.
Överblick
Vad handlar denna studie om?
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.
Viktiga punkter
- 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.
- Att delta är frivilligt, och du kan dra dig ur när som helst.
Vem kan vara berättigad?
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.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- I am aged 18 or older.
- I have been diagnosed with nonsegmental vitiligo.
- I have vitiligo patches on both my body and my face.
- I am willing to pause my current vitiligo creams and light therapy.
- I do not have a history of serious blood clots, heart disease, or chronic infections.
- I am not pregnant, planning a pregnancy, or breastfeeding.
Vad innebär deltagande?
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.
Potentiella risker och fördelar
Platser (86)
- University of Alabama At Birmingham Hospital-Whitaker ClinicVerifierat postnummerBirmingham, USA
- C2 Research Center, LlcVerifierat postnummerMontgomery, USA
- First Oc Dermatology Research IncVerifierat postnummerFountain Valley, United States
- Center For Dermatology Clinical Research, IncVerifierat postnummerFremont, United States
- Marvel Clinical Research LlcVerifierat postnummerHuntington Beach, USA
- Vitiligo & Pigmentation Institute of Southern CaliforniaVerifierat postnummerLos Angeles, USA
- Dermatology Research AssociatesVerifierat postnummerLos Angeles, USA
- Clinical Trials Research InstituteVerifierat postnummerThousand Oaks, USA
- Skin Care Research, LlcVerifierat postnummerBoca Raton, Förenta staterna
- Total Vein and Skin LlcVerifierat postnummerBoynton Beach, United States
- Driven Research LlcVerifierat postnummerCoral Gables, United States
- Florida Academic Centers Research and Education LlcVerifierat postnummerCoral Gables, United States
Vanliga frågor
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.
Vad är en 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.
Kan jag ändra mig efter att jag har gått med?
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.
Hur du får reda på mer
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Diskussion
Gemenskapsdiskussion
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