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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513171-41-00 | Registry Identifier | EU CT Number |
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The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in children (6 to < 12 years old) with nonsegmental vitiligo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib 0.75 % Cream | Experimental | Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol. |
|
| Ruxolitinib 1.5 % Cream | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. |
|
| Vehicle Cream | Placebo Comparator | Participants received vehicle cream, applied topically to the affected area as defined by the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib Cream | Drug | Ruxolitinib cream applied topically to the affected area as a thin film twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) | ≥75% improvement in facial Vitiligo Area Scoring Index. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) | ≥50% improvement in facial Vitiligo Area Scoring Index. | Week 24 |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psoriahue | Not yet recruiting | Buenos Aires | 01425 | Argentina | ||
| Hospital Italiano de Buenos Aires |
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| Label | URL |
|---|---|
| A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to \< 12 Years Old) With Nonsegmental Vitiligo | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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|
| Vehicle Cream | Drug | Matching vehicle cream applied topically to the affected area as a thin film twice daily. |
|
≥90% improvement in facial Vitiligo Area Scoring Index.
| Week 24 |
| Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) | ≥50% improvement in total body Vitiligo Area Scoring Index. | Week 24 |
| Percentage change from baseline in F-BSA | Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area. | Week 24 |
| Number of Treatment Emergent Adverse Events (TEAEs) | TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to Week 52 and 30 days |
| Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable) | The VNS is a patient-reported measure of vitiligo treatment success that has a 5-point scale. | Week 24 and Week 52 |
| Proportion of participants in each category for the color-matching question | The color-matching question is a patient-reported measure of vitiligo treatment success that has a 5-point scale. | Week 24 and Week 52 |
| Proportion of participants who report facial assessment of Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of very much improved or much improved | The F-PaGIC-V is an assessment of improvement by the participant that has a 7-point scale. | Week 24 and Week 52 |
| Proportion of participants who report total body assessment of Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of very much improved or much improved | The T-PaGIC-V is an assessment of improvement by the participant that has a 7-point scale. | Week 24 and Week 52 |
| Change from baseline in Psychosocial Impact Questionnaire for Pediatric Patients Who Have Nonsegmental Vitiligo (VIT-PIQ) | The VIT-PIQ is a 17-item questionnaire to assess Quality of Life (QOL) of children with vitiligo. | Week 24 and Week 52 |
| Change from baseline in Children's Dermatology Life Quality Index (CDLQI) | The CDLQI is the youth/children's version of the Dermatology Life Quality Index. | Week 24 and Week 52 |
| Change from baseline in Patient Global Impression of Bother - Vitiligo (PGIB-V) | The PGIB-V is a single question with an 11-point scale ("not at all" to "a whole lot") to assess the participant's level of bother because of their vitiligo. | Week 24 and Week 52 |
| Mean satisfaction score | The treatment satisfaction tool is a fit-for-purpose questionnaire to assess treatment satisfaction in children with nonsegmental vitiligo. | Week 24 and Week 52 |
| Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations | Trough is defined as the concentration reached by a drug immediately before the next dose is administered. | Weeks 6, 24, 30 and 52 |
| Not yet recruiting |
| Buenos Aires |
| C1181ACH |
| Argentina |
| Instituto de Neumonologia Y Dermatologia | Not yet recruiting | Buenos Aires | C1425BEA | Argentina |
| Consultorios Medicos Dr. Doreski | Not yet recruiting | Buenos Aires | C1426 | Argentina |
| Derma Internacional S.A. | Not yet recruiting | Buenos Aires | C1426 | Argentina |
| Centro de Investigaciones Medicas Mar Del Plata | Not yet recruiting | Mar del Plata | B7600FYK | Argentina |
| Hospital Universitario Austral | Not yet recruiting | Pilar | B16290DT | Argentina |
| Hospital Del Nino Jesus | Not yet recruiting | San Miguel de Tucumán | 04000 | Argentina |
| Universitaetsklinikum Graz | Recruiting | Graz | 08036 | Austria |
| Medical University Innsbruck | Not yet recruiting | Innsbruck | 06020 | Austria |
| Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel) | Recruiting | Brussels | 01070 | Belgium |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 09000 | Belgium |
| Universitair Ziekenhuis Leuven | Recruiting | Leuven | 03000 | Belgium |
| Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc | Not yet recruiting | Woluwe-Saint-Lambert | 01200 | Belgium |
| Medical Center Asklepii Ood | Recruiting | Dupnitsa | 02600 | Bulgaria |
| Mhat Dr. Tota Venkova Ad | Recruiting | Gabrovo | 05300 | Bulgaria |
| Medical Center Medkonsult Pleven Ood | Not yet recruiting | Pleven | 05800 | Bulgaria |
| Medical Center Unimed Eood | Recruiting | Sevlievo | 05400 | Bulgaria |
| Umhat Aleksandrovska | Not yet recruiting | Sofia | 01431 | Bulgaria |
| 28 Diagnostic and Consultative Center | Recruiting | Sofia | 01528 | Bulgaria |
| Mc Euroderma Clinic | Recruiting | Sofia | 01606 | Bulgaria |
| Diagnostic Consultation Center Xx - Sofia Eood | Recruiting | Sofia | 01618 | Bulgaria |
| Sanos Clinic | Not yet recruiting | Gandrup | 09362 | Denmark |
| Herlev and Gentofte Hospital | Recruiting | Hellerup | 02900 | Denmark |
| Centre Hospitalier Victor Dupouy | Not yet recruiting | Argenteuil | 95107 | France |
| Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin | Recruiting | Bordeaux | 33076 | France |
| Centre Hospitalier Intercommunal de Creteil | Not yet recruiting | Créteil | 94010 | France |
| Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh) | Recruiting | Lyon | 69003 | France |
| Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu | Not yet recruiting | Nantes | 44093 | France |
| Centre Hospitalier Universitaire de Nice,Hopital L Archet | Not yet recruiting | Nice | 06200 | France |
| Hopital Universitaire Necker Enfants Malades | Not yet recruiting | Paris | 75015 | France |
| Polyclinique de Courlancy | Not yet recruiting | Reims | 51100 | France |
| Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey | Recruiting | Toulouse | 31059 | France |
| Chu Nancy | Not yet recruiting | Vandœuvre-lès-Nancy | 54500 | France |
| Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm) | Recruiting | Berlin | 10117 | Germany |
| Universitaetsklinikum Der Ruhr Universitaet Bochum (Ukrub), St. Josef Hospital | Not yet recruiting | Bochum | 44791 | Germany |
| Drk Krankenhaus Chemnitz-Rabenstein | Withdrawn | Chemnitz | 09117 | Germany |
| Hautklinik Universitatsklinikum Erlangen | Not yet recruiting | Erlangen | 91054 | Germany |
| Universitaetsklinik Frankfurt | Withdrawn | Frankfurt | 60590 | Germany |
| Katholisches Kinderkrankenhaus Wilhelmstift | Recruiting | Hamburg | 22149 | Germany |
| University Medical Center Schleswig-Holstein | Recruiting | Kiel | 24105 | Germany |
| Universitaetsklinikum Leipzig | Recruiting | Leipzig | 04103 | Germany |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii | Not yet recruiting | Mainz | 55131 | Germany |
| Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar) | Recruiting | München | 81675 | Germany |
| University Hospital Muenster | Recruiting | Münster | 48149 | Germany |
| Clinexpert | Recruiting | Budapest | 01033 | Hungary |
| Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika | Recruiting | Debrecen | 04032 | Hungary |
| University of Pecs-Clinical Center | Not yet recruiting | Pécs | 07632 | Hungary |
| University of Szeged | Not yet recruiting | Szeged | 06720 | Hungary |
| A.O. Policlinico Sant'Orsola Malpighi-Universita Degli Studi Di Bologna | Not yet recruiting | Bologna | 40138 | Italy |
| Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia | Not yet recruiting | Brescia | 25123 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania | Not yet recruiting | Catania | 95123 | Italy |
| Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda | Not yet recruiting | Milan | 20122 | Italy |
| Universita Degli Studi Di Napoli Federico Ii | Not yet recruiting | Naples | 80131 | Italy |
| Azienda Ospedale Universita Di Padova | Not yet recruiting | Padua | 35100 | Italy |
| Fondazione Ptv Policlinico Tor Vergata | Withdrawn | Roma | 00133 | Italy |
| Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss) | Not yet recruiting | Roma | 00167 | Italy |
| Irccs Ospedale Pediatrico Bambino Gesu | Not yet recruiting | Rome | 00165 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs | Not yet recruiting | Rome | 00168 | Italy |
| Amsterdam Umc Research Bv | Recruiting | Amsterdam | 1105 AZ | Netherlands |
| Centrum Badan Klinicznych Pi-House Sp. Z O.O. | Recruiting | Gdansk | 80-546 | Poland |
| Care Clinic Sp. Z O.O. | Recruiting | Katowice | 40-568 | Poland |
| Diamond Clinic Specjalistyczne Poradnie Lekarskie | Recruiting | Krakow | 31-559 | Poland |
| Dermedic Iwona Zdybska | Recruiting | Lublin | 20-607 | Poland |
| Twoja Przychodnia - Medyczne Nowa Sol | Recruiting | Nowa Sól | 67-100 | Poland |
| Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski | Recruiting | Osielsko | 86-031 | Poland |
| Dermedic Jacek Zdybski | Withdrawn | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie | Recruiting | Rzeszów | 35-055 | Poland |
| Twoja Przychodnia Scm | Recruiting | Szczecin | 71-500 | Poland |
| Evimed Sp. Z O. O. | Recruiting | Warsaw | 02-625 | Poland |
| Centro Hospitalar E Universitario Coimbra | Not yet recruiting | Coimbra | 3000-602 | Portugal |
| Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos | Not yet recruiting | Lisbon | 1169-050 | Portugal |
| Hospital Geral de Santo Antonio | Recruiting | Porto | 4099-001 | Portugal |
| Hospital Universitario Fundacion Alcorcon | Recruiting | Alcorcón | 28922 | Spain |
| Hospital Universitari Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hospital de La Santa Creu I Sant Pau | Recruiting | Barcelona | 08026 | Spain |
| Hospital Sant Joan de Deu Barcelona | Recruiting | Esplugues de Llobregat | 08950 | Spain |
| Hospital Infantil Unversitario Nino Jesus | Recruiting | Madrid | 28009 | Spain |
| Hospital Universitario Miguel Servet de Zaragoza | Recruiting | Zaragoza | 50009 | Spain |
| Croydon University Hospital | Not yet recruiting | Croydon | CR7 7YE | United Kingdom |
| The Royal London Hospital - Barts Health Nhs Trust | Not yet recruiting | London | E1 1FR | United Kingdom |
| Guys Hospital | Not yet recruiting | London | SE1 9RT | United Kingdom |
| Great Ormond Street Hospital For Children Nhs Foundation Trust | Not yet recruiting | London | WC1N 3JH | United Kingdom |
| Queen'S Medical Centre - Nottingham University Hospitals Nhs Trust | Not yet recruiting | Nottingham | NG7 2UH | United Kingdom |
| Sheffield Childrens Hospital | Not yet recruiting | Sheffield | S10 2TH | United Kingdom |
| Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust | Not yet recruiting | Walsall | WS2 9PS | United Kingdom |