Study on Ritlecitinib for Adults and Adolescents with Nonsegmental Vitiligo

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What is this study about?

This clinical trial is focused on studying nonsegmental vitiligo, a condition where patches of skin lose their color. The study is testing a treatment called Ritlecitinib tosilate, which is taken as a capsule. Participants will be randomly assigned to receive either the treatment or a placebo, which looks like the treatment but does not contain the active medicine. The purpose of the study is to evaluate how effective, safe, and tolerable the treatment is for people with nonsegmental vitiligo.

The study will last for 52 weeks, during which participants will take the medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. These check-ups will help researchers understand how well the treatment works and if there are any side effects. The study aims to see if the treatment can improve the skin condition by at least 75% over the course of the study.

Participants in the study will include adults and adolescents who have been diagnosed with nonsegmental vitiligo for at least three months. The study will help gather important information about the potential benefits and risks of using Ritlecitinib tosilate for treating this condition. This information could lead to new treatment options for people living with nonsegmental vitiligo.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your age and medical condition, specifically nonsegmental vitiligo. Your body surface area (BSA) affected by vitiligo will be measured, and you will be asked to stop any other treatments for vitiligo.

3 randomization

You will be randomly assigned to receive either the study medication, ritlecitinib tosilate, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

4 medication administration

If you are assigned to the study medication, you will take ritlecitinib tosilate orally at a dose of 50 mg once daily. If you are assigned to the placebo group, you will take a placebo capsule once daily. This will continue for a duration of 52 weeks.

5 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. These visits will include assessments of your vitiligo, general health evaluations, and laboratory tests to ensure your safety.

6 evaluation of treatment response

Your response to the treatment will be evaluated at various points, specifically at weeks 24, 36, and 52. This will involve measuring improvements in your vitiligo using specific scales and questionnaires.

7 completion of the study

At the end of the 52-week period, you will have a final assessment to evaluate the overall effects of the treatment. You will also discuss any further steps or follow-up care that may be necessary.

Who Can Join the Study?

Participants must be 18 years of age or older at the time of screening. Adolescents aged 12 to under 18 may also be eligible if approved by local authorities.
Participants must have a clinical diagnosis of nonsegmental vitiligo for at least 3 months.
The affected skin area must be between 4% and 60% of the body, not including the palms, soles, or the top of the feet.
There must be at least 0.5% of the face affected by vitiligo. The face includes the forehead, cheeks, jawline, nose, and eyelids, but not the scalp, ears, neck, or lips.
Participants must have specific scores on skin assessments called F-VASI (Face Vitiligo Area Scoring Index) and T-VASI (Total Vitiligo Area Scoring Index).
Participants can have either active or stable vitiligo at both the screening and baseline visits. If the vitiligo is not active, it must be stable.
Participants must agree to stop all other treatments for vitiligo from the screening through the final follow-up visit.

Who Cannot Join the Study?

Participants with any other skin condition that might interfere with the study results.
Individuals who have had a major surgery within the last 4 weeks.
People who are currently participating in another clinical trial.
Anyone who has a history of severe allergic reactions to medications.
Participants who are pregnant or breastfeeding.
Individuals with a history of cancer, except for certain types of skin cancer.
People with uncontrolled medical conditions, such as diabetes or high blood pressure.
Anyone who has used certain medications that might affect the study results within the last 4 weeks.
Individuals with a history of drug or alcohol abuse within the last year.
Participants who have received a live vaccine within the last 4 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Dermedic Jacek Zdybski	Ostrowiec Swietokrzyski	Poland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.	Osielsko	Poland
Royalderm Agnieszka Nawrocka	Warsaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hautarztpraxis Dr. Leitz Und Kollegen	Stuttgart	Germany
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
El Hospital Universitario De Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria	Spain
Asclepius Medical Center OOD	Dupnitsa	Bulgaria
Uunijdlrspvrybrxqvgmc Mvfzmnno Aej	Munster	Germany
Awbsjnb Ukaty Sgrjjseiy Lzrmrp Db Bapvrfd	Bologna	Italy
Ieqcjo Irbyresx Fobfdubgaogyn Ocpmqlkcewp	Rome	Italy
Tvtuzztytfe ulp Srbgperygpp Bybtbauh Gjre	Bad Bentheim	Germany

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	25.03.2023
Germany	Not recruiting	25.03.2023
Italy	Not recruiting	25.03.2023
Poland	Not recruiting	25.03.2023
Spain	Not recruiting	25.03.2023

Trial locations

Investigated drugs:

Dexamethasone

Ritlecitinib is a medication being studied for its potential to help people with nonsegmental vitiligo, a condition where the skin loses its color in patches. This medication works by targeting specific pathways in the immune system that may be involved in the development of vitiligo. The goal of using ritlecitinib in this trial is to see if it can help restore skin color and improve the appearance of the skin over time. Additionally, the study aims to ensure that ritlecitinib is safe and well-tolerated by participants.

Investigated diseases:

Vitiligo

Nonsegmental Vitiligo – Nonsegmental vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on the skin. It occurs when the cells responsible for skin color, called melanocytes, are destroyed. This type of vitiligo is the most common form and typically affects both sides of the body symmetrically. The progression of nonsegmental vitiligo can vary, with some individuals experiencing rapid loss of skin color, while others may have a more gradual change. The condition can also affect hair, turning it white or gray. The exact cause of the destruction of melanocytes is not fully understood, but it is believed to involve genetic and autoimmune factors.

Trial ID:

2022-501668-16-00

Protocol code:

B7981040

NCT ID:

NCT05583526

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Ritlecitinib for Adults and Adolescents with Nonsegmental Vitiligo

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