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

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Hospital General Universitario De Valencia Valencia Spain
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Amphia Hospital Breda The Netherlands
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Semmelweis University Budapest Hungary
Cbbdayddf Uxhfytbbiiayek Sifwgffga Woluwe-Saint-Lambert Belgium
Udvnshrdigxwbjlnawsab Eodwycyt Arz Erlangen Germany
Alniiwefv Urs Amsterdam The Netherlands
Csrxauw Ussacoubansknltnbtgh Bhkere Keu Berlin Germany
Cnapop Hcwltdzlou E Uwwxttnhrskbj Dr Cnepkfy Eqxmts Coimbra Portugal
Urltndbenkzrcxcfcpwbp Mrmghici Ava Munster Germany
Pvubcvd Sfs z oijl Katowice Poland
Knemlscp dmh Thknuxoyrhe Usiryzzmawlz Mcrcbuih (vso Kovmmqmcl Munich Germany
Iymnnk Iciuglua Ficatzeusxgxm Orieimqwfgs Rome Italy
Cldsms heugwwxrwyg ukjpvtqaqhhsu df Lqruw Liege Belgium
Uycuterkysam Zyhzdevbfr Gwod Gent Belgium
Ufjleosdzz Drjgh Stbee Dh Bnfhknw Brescia Italy
Fyqkjyjl Nuemcrzdr Tnlfxi Trnava Slovakia
Hoqqjcno Cntociy Ubuaaebbsncob Lqpibw Bomrm Zaragoza Spain
Kglkzxg Aawpjnjoj Szf z ohtz Warsaw Poland
Mxbylzp Cnyppg Kcispz Ocu Pleven Bulgaria
Abje – Ionar &iqiyeh Smtv Ayo Vnkvuzom Dbfyhxxa Sofia Bulgaria
Hxapqcsq Uhytmtqkuxlkp Qfaudjdoteh Mdlumj Pozuelo De Alarcon Spain
Gjjdeybotafrjlao Znbhpbo Bfot Bonn Germany
Gkpsgt Uqgdgeqqsz Fryyivtkj Frankfurt Germany
Bopmpk Zbquptfaro Roosendaal The Netherlands
Hpxjoowd Evjexso Hgocfqa Lyon France
Hdlxrweo Udzfxjutknotk Df Giihmw Getafe Spain
Gqjzj Hagfwgx Dc Cbvdxlyzh Charleroi Belgium
Tgpit Pvhtzblztmb Svynekyozhlt Cgjcebb Mwkmqvly Sfv z omdr Szczecin Poland
Hngnpdie Coa Diehsovioaz Swca Lisbon Portugal
Thzgweouxti uoq Szgxgoyyaed Bzmyjvku Grvb Bad Bentheim Germany
Mctgvhvtdmk Cevvcms Kualcdchp Cracow Poland
Fkqpvfpfrdqvbv Gyzbpsyphulmnrfuamg fuzd Dxvsmmtcgfhf Uqt Vhzwrupgnlj Aewzrquatnvw Uvaatrrlgriel Llvmingrhfea Gov Blankenfelde-Mahlow Germany
Dxbdnua Kxoa Debrecen Hungary
Dbybx tfgimcn swzab s rzxf Petrzalka Slovakia
Hlivaifw Ujqcvsszcdcks Hvjgrbyj Tgjnn y Pltupl Iaufedyw Cdtgau dhhluabbaqxsjcnti (teog Badalona Spain
Ktovzcq Ojbkwdoux &enyb Tmgddzyjt Sqo z otfq Warsaw Poland
Rnwgensau Abszubkqr Nwbgnbsr Warsaw Poland
Djnavboxr Cmmnrim Mteajvok Anzpnt Cffshphszs Rysjw Cxtdaqbqvt sff Osielsko Poland
Mggjyubn mshmvvq aktjmtl &yeagau Mmik &ijfjxp Socay Sofia Bulgaria
Cxongh Hstodshdoqd Uqhhtjqcrjfon Dv Bjkfprjx Bordeaux France
Cqtiep Hyagsynqdmr Uwtdqzkyodfbc Di Tthbnexd Toulouse France
Cwrwgh Hcdwvgourey Usyedewbohvum Dd Nbqo Nice France
Ctsvxn Hthhugvefm Uyvlgriwiywuf Do Pwmvd Ephntu Porto Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

Trial locations

Investigated Drugs:

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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