Study on the Effects of Upadacitinib in Adults and Adolescents with Non-Segmental Vitiligo Eligible for Systemic Treatment

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Upadacitinib in treating a skin condition known as non-segmental vitiligo. Non-segmental vitiligo is a condition where patches of skin lose their color. The study will involve adult and adolescent participants who are eligible for systemic therapy, which means they can receive treatment that affects the entire body, not just the skin.

The purpose of the study is to evaluate how effective, safe, and tolerable Upadacitinib is for treating non-segmental vitiligo. Participants will be randomly assigned to receive either the medication or a placebo, which is a substance with no active ingredients. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased.

Throughout the study, participants will take the medication in the form of modified-release tablets, which are designed to release the drug slowly over time. The study will last for a period of time, during which participants will be monitored for any changes in their condition and any side effects they may experience. The goal is to determine if Upadacitinib can significantly improve the skin condition of those with non-segmental vitiligo.

1 joining the study

Upon joining the study, the participant will be required to sign an informed consent form. This document confirms understanding and agreement to follow the study’s requirements.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying age, weight, and a clinical diagnosis of non-segmental vitiligo.

Participants must have previously tried at least one topical treatment for vitiligo without success or have signs of actively progressing vitiligo.

3 medication administration

Participants will receive either upadacitinib or a placebo. Upadacitinib is administered as a modified-release tablet taken orally.

The dosage and frequency of administration will be determined by the study protocol.

4 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor the effectiveness and safety of the treatment.

These assessments will include measurements of vitiligo area and severity index (VASI) to track changes in skin condition.

5 primary evaluation

The primary evaluation will occur at Week 48. The goal is to achieve a significant reduction in vitiligo severity, measured by T-VASI 50 and F-VASI 75.

6 secondary evaluation

Secondary evaluations will also be conducted, focusing on additional improvements in vitiligo severity and participant-reported outcomes.

These evaluations will occur at various points, including Week 24 and Week 48.

7 study completion

The study is expected to conclude by February 2028. Participants will receive a final assessment to determine the overall effectiveness and safety of the treatment.

Who Can Join the Study?

The person or their legal representative must understand and agree to follow all study requirements and sign a consent form before any study procedures begin.
Participants must be adults or adolescents who are 12 years of age or older at the time of screening.
For participants aged 12 to 17, their body weight must be at least 30 kg at the start of the study.
Participants must have certain laboratory test results that meet the study’s requirements before starting the study medication.
Participants must have a confirmed diagnosis of non-segmental vitiligo (NSV), which is a type of skin condition.
At the screening and start of the study, participants must meet at least one of the following conditions:
- Have a certain level of skin involvement measured by F-VASI and T-VASI scores, and have not responded to at least one topical corticosteroid or calcineurin inhibitor treatment for vitiligo.
- Have a certain level of skin involvement measured by F-VASI and T-VASI scores, and show signs of vitiligo that is actively getting worse.
- Have a certain level of skin involvement measured by F-VASI and T-VASI scores.
Participants must not have segmental or localized vitiligo, which are other types of skin conditions.
Participants must not have any other active skin diseases that could affect the assessment of vitiligo.
Participants must not have more than 33% leukotrichia (white hair) in the areas of vitiligo on the face or body.

Who Cannot Join the Study?

Patients who have a different type of vitiligo than non-segmental vitiligo cannot participate. Non-segmental vitiligo is a condition where the skin loses its color in patches.
Patients who are not eligible for systemic therapy cannot participate. Systemic therapy is a treatment that affects the entire body, not just one part.
Patients who are outside the specified age range cannot participate. The study is for certain age groups only.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Praxis Dr. med. Abdou Zarzour	Halle (Saale)	Germany
ICMR (International Center for Medical Research)	Madrid	Spain
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy M. Brzewski, P. Brzewski S.C.	Cracow	Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Futuremeds Sp. z o.o.	Wroclaw	Poland
Oncopole Claudius Regaud	Toulouse	France
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.	Osielsko	Poland
Royalderm Agnieszka Nawrocka	Warsaw	Poland

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Edouard Herriot	Lyon	France
Amphia Hospital	Breda	The Netherlands
Hospital Universitario De Getafe	Getafe	Spain
Grand Hopital De Charleroi	Charleroi	Belgium
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Fakultna Nemocnica Trnava	Trnava	Slovakia
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Derma-B Kft.	Debrecen	Hungary
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Derma therapy spol. s r.o.	Petrzalka	Slovakia
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR	Blankenfelde-Mahlow	Germany
Malopolskie Centrum Kliniczne	Cracow	Poland
Dkc Fokus-5 Lzip OOD	Sofia	Bulgaria
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Semmelweis University	Budapest	Hungary
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Diagnostic Consultation Center XX-Sofia EOOD	Sofia	Bulgaria
Centre Hospitalier Universitaire De Nice	Nice	France
Bravis Ziekenhuis	Roosendaal	The Netherlands
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
ASMC – IPSMC – Skin And Venereal Diseases	Sofia	Bulgaria
Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov	Presov	Slovakia
Klinika Osipowicz & Turkowski Sp. z o.o.	Warsaw	Poland
Creoliaei Uhaygeahgbtvgc Sbxqnazso	Woluwe-Saint-Lambert	Belgium
Iwienl Iczalrhu Frgtxhzflehka Oqlqvisvwmv	Rome	Italy
Tntbebzwccy umv Szdzqbxykoa Baaqfzkb Gsps	Bad Bentheim	Germany
Mxtdmeh Cqhjib Kceivx Opx	Pleven	Bulgaria
Awztggqgg Uia	Amsterdam	The Netherlands
Ugkalbxmxqpzbfvbnvbyj Mqlautze Ape	Munster	Germany
Ganjbwavfcjzptuv Zvwlzat Bcci	Bonn	Germany
Gpjyei Ufhnlksaxi Fgsdxmbek	Frankfurt	Germany
Pvxsvwt Sec z oetj	Katowice	Poland
Mmqncawq Mqwhttc Ajyayup	Pleven	Bulgaria
Hkchxwcf Uhirtbwclnkgj Htrhrxvq Toxyt y Punzvb Ibfutlas Cikcyh dighqcazvsfrcqjhm (vugf	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.04.2024
Bulgaria	Not recruiting	01.04.2024
France	Not recruiting	01.04.2024
Germany	Not recruiting	01.04.2024
Hungary	Not recruiting	01.04.2024
Italy	Not recruiting	01.04.2024
Poland	Not recruiting	01.04.2024
Portugal	Not recruiting	01.04.2024
Slovakia	Not recruiting	01.04.2024
Spain	Not recruiting	01.04.2024
The Netherlands	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Upadacitinib

Upadacitinib is a medication being studied for its effectiveness, safety, and tolerability in treating non-segmental vitiligo in adults and adolescents. This condition causes patches of skin to lose their color. Upadacitinib is being tested to see if it can help improve the appearance of the skin by restoring its natural color.

Non-segmental vitiligo – Non-segmental vitiligo is a skin condition characterized by the loss of pigment, resulting in white patches on various parts of the body. It occurs when the cells responsible for skin color, called melanocytes, are destroyed. The progression of this condition is unpredictable, with patches often appearing symmetrically on both sides of the body. These patches can increase in size and spread over time, affecting larger areas of the skin. The condition can also impact hair, turning it white or gray in the affected areas. Non-segmental vitiligo can start at any age and may progress slowly or rapidly.

Trial ID:

2023-506195-27-00

Protocol code:

M19-044

NCT ID:

NCT06118411

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Upadacitinib in Adults and Adolescents with Non-Segmental Vitiligo Eligible for Systemic Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?