A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

NCT06804811 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: INCB18424-3092024-513171-41-00
• Study Type: interventional
• Target: 250
• Locations: 14 countries
• Sites: 86

Brief Summary

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.

Conditions

NonSegmental Vitiligo

Keywords

NonSegmental Vitiligo; pediatric

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)

  Week 24

• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)

  Week 24

• Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)

  Week 24

• Percentage change from baseline in F-BSA

  Week 24

• Number of Treatment Emergent Adverse Events (TEAEs)

  Up to Week 52 and 30 days

Study Arms (3)

Ruxolitinib 0.75 % Cream

EXPERIMENTAL

Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol.

Drug: Ruxolitinib Cream

Ruxolitinib 1.5 % Cream

EXPERIMENTAL

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

Drug: Ruxolitinib Cream

Vehicle Cream

PLACEBO COMPARATOR

Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Drug: Vehicle Cream

Interventions

Vehicle Cream DRUG

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Vehicle Cream

Ruxolitinib Cream DRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Also known as: INCB018424 Phosphate Cream

Ruxolitinib 0.75 % Cream; Ruxolitinib 1.5 % Cream

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 to \< 12 years at the time of signing the ICF.
• Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI.
• Total body vitiligo area does not exceed 10% BSA.
• Pigmented hair within some of the areas of vitiligo on the face.
• Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit.
• For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child as defined in the protocol.

You may not qualify if:

• Diagnosis of other forms of vitiligo (eg, segmental).
• Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
• Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.
• Prior or current use of depigmentation treatments (eg, monobenzone).
• Concurrent conditions and history of protocol-defined diseases
• Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
• Use of protocol-defined treatments within the indicated washout period before baseline.
• History of treatment failure with any systemic or topical JAK inhibitor for vitiligo or any other inflammatory condition.
• Protocol-defined clinically significant abnormal laboratory values at screening.
• BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.
• Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
• In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations.
• Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
• Employees of the sponsor or investigator or are otherwise dependents of them.
• Known allergy or reaction to any component of the study cream formulation.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (86)

Psoriahue

Buenos Aires, 01425, Argentina

NOT YET RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

NOT YET RECRUITING

Instituto de Neumonologia Y Dermatologia

Buenos Aires, C1425BEA, Argentina

NOT YET RECRUITING

Consultorios Medicos Dr. Doreski

Buenos Aires, C1426, Argentina

NOT YET RECRUITING

Derma Internacional S.A.

Buenos Aires, C1426, Argentina

NOT YET RECRUITING

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, B7600FYK, Argentina

NOT YET RECRUITING

Hospital Universitario Austral

Pilar, B16290DT, Argentina

NOT YET RECRUITING

Hospital Del Nino Jesus

San Miguel de Tucumán, 04000, Argentina

NOT YET RECRUITING

Universitaetsklinikum Graz

Graz, 08036, Austria

RECRUITING

Medical University Innsbruck

Innsbruck, 06020, Austria

NOT YET RECRUITING

Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)

Brussels, 01070, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 09000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven

Leuven, 03000, Belgium

RECRUITING

Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, 01200, Belgium

NOT YET RECRUITING

Medical Center Asklepii Ood

Dupnitsa, 02600, Bulgaria

RECRUITING

Mhat Dr. Tota Venkova Ad

Gabrovo, 05300, Bulgaria

RECRUITING

Medical Center Medkonsult Pleven Ood

Pleven, 05800, Bulgaria

NOT YET RECRUITING

Medical Center Unimed Eood

Sevlievo, 05400, Bulgaria

RECRUITING

Umhat Aleksandrovska

Sofia, 01431, Bulgaria

NOT YET RECRUITING

28 Diagnostic and Consultative Center

Sofia, 01528, Bulgaria

RECRUITING

Mc Euroderma Clinic

Sofia, 01606, Bulgaria

RECRUITING

Diagnostic Consultation Center Xx - Sofia Eood

Sofia, 01618, Bulgaria

RECRUITING

Sanos Clinic

Gandrup, 09362, Denmark

NOT YET RECRUITING

Herlev and Gentofte Hospital

Hellerup, 02900, Denmark

RECRUITING

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

NOT YET RECRUITING

Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

RECRUITING

Centre Hospitalier Intercommunal de Creteil

Créteil, 94010, France

NOT YET RECRUITING

Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)

Lyon, 69003, France

RECRUITING

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu

Nantes, 44093, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Nice,Hopital L Archet

Nice, 06200, France

NOT YET RECRUITING

Hopital Universitaire Necker Enfants Malades

Paris, 75015, France

NOT YET RECRUITING

Polyclinique de Courlancy

Reims, 51100, France

NOT YET RECRUITING

Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey

Toulouse, 31059, France

RECRUITING

Chu Nancy

Vandœuvre-lès-Nancy, 54500, France

NOT YET RECRUITING

Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)

Berlin, 10117, Germany

RECRUITING

Universitaetsklinikum Der Ruhr Universitaet Bochum (Ukrub), St. Josef Hospital

Bochum, 44791, Germany

NOT YET RECRUITING

Drk Krankenhaus Chemnitz-Rabenstein

Chemnitz, 09117, Germany

WITHDRAWN

Hautklinik Universitatsklinikum Erlangen

Erlangen, 91054, Germany

NOT YET RECRUITING

Universitaetsklinik Frankfurt

Frankfurt, 60590, Germany

WITHDRAWN

Katholisches Kinderkrankenhaus Wilhelmstift

Hamburg, 22149, Germany

RECRUITING

University Medical Center Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

NOT YET RECRUITING

Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar)

München, 81675, Germany

RECRUITING

University Hospital Muenster

Münster, 48149, Germany

RECRUITING

Clinexpert

Budapest, 01033, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

Debrecen, 04032, Hungary

RECRUITING

University of Pecs-Clinical Center

Pécs, 07632, Hungary

NOT YET RECRUITING

University of Szeged

Szeged, 06720, Hungary

NOT YET RECRUITING

A.O. Policlinico Sant'Orsola Malpighi-Universita Degli Studi Di Bologna

Bologna, 40138, Italy

NOT YET RECRUITING

Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia

Brescia, 25123, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania

Catania, 95123, Italy

NOT YET RECRUITING

Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda

Milan, 20122, Italy

NOT YET RECRUITING

Universita Degli Studi Di Napoli Federico Ii

Naples, 80131, Italy

NOT YET RECRUITING

Azienda Ospedale Universita Di Padova

Padua, 35100, Italy

NOT YET RECRUITING

Fondazione Ptv Policlinico Tor Vergata

Roma, 00133, Italy

WITHDRAWN

Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)

Roma, 00167, Italy

NOT YET RECRUITING

Irccs Ospedale Pediatrico Bambino Gesu

Rome, 00165, Italy

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Rome, 00168, Italy

NOT YET RECRUITING

Amsterdam Umc Research Bv

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Centrum Badan Klinicznych Pi-House Sp. Z O.O.

Gdansk, 80-546, Poland

RECRUITING

Care Clinic Sp. Z O.O.

Katowice, 40-568, Poland

RECRUITING

Diamond Clinic Specjalistyczne Poradnie Lekarskie

Krakow, 31-559, Poland

RECRUITING

Dermedic Iwona Zdybska

Lublin, 20-607, Poland

RECRUITING

Twoja Przychodnia - Medyczne Nowa Sol

Nowa Sól, 67-100, Poland

RECRUITING

Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski

Osielsko, 86-031, Poland

RECRUITING

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

WITHDRAWN

Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

Rzeszów, 35-055, Poland

RECRUITING

Twoja Przychodnia Scm

Szczecin, 71-500, Poland

RECRUITING

Evimed Sp. Z O. O.

Warsaw, 02-625, Poland

RECRUITING

Centro Hospitalar E Universitario Coimbra

Coimbra, 3000-602, Portugal

NOT YET RECRUITING

Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos

Lisbon, 1169-050, Portugal

NOT YET RECRUITING

Hospital Geral de Santo Antonio

Porto, 4099-001, Portugal

RECRUITING

Hospital Universitario Fundacion Alcorcon

Alcorcón, 28922, Spain

RECRUITING

Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

RECRUITING

Hospital de La Santa Creu I Sant Pau

Barcelona, 08026, Spain

RECRUITING

Hospital Sant Joan de Deu Barcelona

Esplugues de Llobregat, 08950, Spain

RECRUITING

Hospital Infantil Unversitario Nino Jesus

Madrid, 28009, Spain

RECRUITING

Hospital Universitario Miguel Servet de Zaragoza

Zaragoza, 50009, Spain

RECRUITING

Croydon University Hospital

Croydon, CR7 7YE, United Kingdom

NOT YET RECRUITING

The Royal London Hospital - Barts Health Nhs Trust

London, E1 1FR, United Kingdom

NOT YET RECRUITING

Guys Hospital

London, SE1 9RT, United Kingdom

NOT YET RECRUITING

Great Ormond Street Hospital For Children Nhs Foundation Trust

London, WC1N 3JH, United Kingdom

NOT YET RECRUITING

Queen'S Medical Centre - Nottingham University Hospitals Nhs Trust

Nottingham, NG7 2UH, United Kingdom

NOT YET RECRUITING

Sheffield Childrens Hospital

Sheffield, S10 2TH, United Kingdom

NOT YET RECRUITING

Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust

Walsall, WS2 9PS, United Kingdom

NOT YET RECRUITING

Related Links

• A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to \< 12 Years Old) With Nonsegmental Vitiligo

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 3, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: 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.

Locations

DK (2); HU (4); NL (1); PT (3); PL (10); ES (6); IT (10); DE (11); GB (7); BE (4); AU (2); AR (8); BU (8); FR (10)