Actively Recruiting

Phase 3
Age: 6Years - 11Years
All Genders
NCT06804811

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

Led by Incyte Corporation · Updated on 2025-12-17

250

Participants Needed

86

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 6 to < 12 years at the time of signing the informed consent form
  • Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% body surface area (BSA) on the face, ≥ 0.5 Facial Vitiligo Area Scoring Index (F-VASI), ≥ 3% BSA on nonfacial areas, and ≥ 3 Total Vitiligo Area Scoring Index (T-VASI)
  • Total body vitiligo area does not exceed 10% BSA
  • Presence of pigmented hair within some of the areas of vitiligo on the face
  • Agreement to stop all vitiligo treatments from screening through the final safety follow-up visit
  • For sexually active participants (except prepubescent), willingness to avoid pregnancy or fathering a child as defined in the protocol
Not Eligible

You will not qualify if you...

  • Diagnosis of segmental or other forms of vitiligo
  • Other skin depigmentation disorders such as piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, or tinea versicolor
  • Any other skin disease that may interfere with study drug application or assessments
  • Prior or current use of depigmentation treatments like monobenzone
  • Concurrent conditions or history of diseases defined by the protocol
  • Serious illness or medical, physical, or psychiatric conditions that may affect participation or study data interpretation
  • Use of protocol-defined treatments within specified washout periods before baseline
  • History of treatment failure with any systemic or topical Janus kinase (JAK) inhibitor for vitiligo or other inflammatory conditions
  • Clinically significant abnormal laboratory values at screening
  • Body mass index (BMI) below 5th percentile or above or equal to 85th percentile for age
  • Pregnant or breastfeeding participants or those considering pregnancy during the study
  • Inability or unlikely to comply with application schedule and study evaluations
  • Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study
  • Employees or dependents of the sponsor or investigator
  • Known allergy or reaction to any component of the study cream
  • In France, vulnerable populations and adults under legal protection or unable to consent as defined by French Public Health Code
  • In the EU, participants considered incapacitated under EU Clinical Trial Regulation
  • Other protocol-defined inclusion/exclusion criteria may apply

AI-Screening

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Trial Site Locations

Total: 86 locations

1

Psoriahue

Buenos Aires, Argentina, 01425

Not Yet Recruiting

2

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina, C1181ACH

Not Yet Recruiting

3

Instituto de Neumonologia Y Dermatologia

Buenos Aires, Argentina, C1425BEA

Not Yet Recruiting

4

Consultorios Medicos Dr. Doreski

Buenos Aires, Argentina, C1426

Not Yet Recruiting

5

Derma Internacional S.A.

Buenos Aires, Argentina, C1426

Not Yet Recruiting

6

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina, B7600FYK

Not Yet Recruiting

7

Hospital Universitario Austral

Pilar, Argentina, B16290DT

Not Yet Recruiting

8

Hospital Del Nino Jesus

San Miguel de Tucumán, Argentina, 04000

Not Yet Recruiting

9

Universitaetsklinikum Graz

Graz, Austria, 08036

Actively Recruiting

10

Medical University Innsbruck

Innsbruck, Austria, 06020

Not Yet Recruiting

11

Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)

Brussels, Belgium, 01070

Actively Recruiting

12

Universitair Ziekenhuis Gent

Ghent, Belgium, 09000

Actively Recruiting

13

Universitair Ziekenhuis Leuven

Leuven, Belgium, 03000

Actively Recruiting

14

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

Woluwe-Saint-Lambert, Belgium, 01200

Not Yet Recruiting

15

Medical Center Asklepii Ood

Dupnitsa, Bulgaria, 02600

Actively Recruiting

16

Mhat Dr. Tota Venkova Ad

Gabrovo, Bulgaria, 05300

Actively Recruiting

17

Medical Center Medkonsult Pleven Ood

Pleven, Bulgaria, 05800

Not Yet Recruiting

18

Medical Center Unimed Eood

Sevlievo, Bulgaria, 05400

Actively Recruiting

19

Umhat Aleksandrovska

Sofia, Bulgaria, 01431

Not Yet Recruiting

20

28 Diagnostic and Consultative Center

Sofia, Bulgaria, 01528

Actively Recruiting

21

Mc Euroderma Clinic

Sofia, Bulgaria, 01606

Actively Recruiting

22

Diagnostic Consultation Center Xx - Sofia Eood

Sofia, Bulgaria, 01618

Actively Recruiting

23

Sanos Clinic

Gandrup, Denmark, 09362

Not Yet Recruiting

24

Herlev and Gentofte Hospital

Hellerup, Denmark, 02900

Actively Recruiting

25

Centre Hospitalier Victor Dupouy

Argenteuil, France, 95107

Not Yet Recruiting

26

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

Bordeaux, France, 33076

Actively Recruiting

27

Centre Hospitalier Intercommunal de Creteil

Créteil, France, 94010

Not Yet Recruiting

28

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

Lyon, France, 69003

Actively Recruiting

29

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

Nantes, France, 44093

Not Yet Recruiting

30

Centre Hospitalier Universitaire de Nice,Hopital L Archet

Nice, France, 06200

Not Yet Recruiting

31

Hopital Universitaire Necker Enfants Malades

Paris, France, 75015

Not Yet Recruiting

32

Polyclinique de Courlancy

Reims, France, 51100

Not Yet Recruiting

33

Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey

Toulouse, France, 31059

Actively Recruiting

34

Chu Nancy

Vandœuvre-lès-Nancy, France, 54500

Not Yet Recruiting

35

Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)

Berlin, Germany, 10117

Actively Recruiting

36

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

Bochum, Germany, 44791

Not Yet Recruiting

37

Drk Krankenhaus Chemnitz-Rabenstein

Chemnitz, Germany, 09117

Withdrawn

38

Hautklinik Universitatsklinikum Erlangen

Erlangen, Germany, 91054

Not Yet Recruiting

39

Universitaetsklinik Frankfurt

Frankfurt, Germany, 60590

Withdrawn

40

Katholisches Kinderkrankenhaus Wilhelmstift

Hamburg, Germany, 22149

Actively Recruiting

41

University Medical Center Schleswig-Holstein

Kiel, Germany, 24105

Actively Recruiting

42

Universitaetsklinikum Leipzig

Leipzig, Germany, 04103

Actively Recruiting

43

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, Germany, 55131

Not Yet Recruiting

44

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

München, Germany, 81675

Actively Recruiting

45

University Hospital Muenster

Münster, Germany, 48149

Actively Recruiting

46

Clinexpert

Budapest, Hungary, 01033

Actively Recruiting

47

Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

Debrecen, Hungary, 04032

Actively Recruiting

48

University of Pecs-Clinical Center

Pécs, Hungary, 07632

Not Yet Recruiting

49

University of Szeged

Szeged, Hungary, 06720

Not Yet Recruiting

50

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

Bologna, Italy, 40138

Not Yet Recruiting

51

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

Brescia, Italy, 25123

Not Yet Recruiting

52

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

Catania, Italy, 95123

Not Yet Recruiting

53

Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda

Milan, Italy, 20122

Not Yet Recruiting

54

Universita Degli Studi Di Napoli Federico Ii

Naples, Italy, 80131

Not Yet Recruiting

55

Azienda Ospedale Universita Di Padova

Padua, Italy, 35100

Not Yet Recruiting

56

Fondazione Ptv Policlinico Tor Vergata

Roma, Italy, 00133

Withdrawn

57

Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)

Roma, Italy, 00167

Not Yet Recruiting

58

Irccs Ospedale Pediatrico Bambino Gesu

Rome, Italy, 00165

Not Yet Recruiting

59

Fondazione Policlinico Universitario Agostino Gemelli Irccs

Rome, Italy, 00168

Not Yet Recruiting

60

Amsterdam Umc Research Bv

Amsterdam, Netherlands, 1105 AZ

Actively Recruiting

61

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

Gdansk, Poland, 80-546

Actively Recruiting

62

Care Clinic Sp. Z O.O.

Katowice, Poland, 40-568

Actively Recruiting

63

Diamond Clinic Specjalistyczne Poradnie Lekarskie

Krakow, Poland, 31-559

Actively Recruiting

64

Dermedic Iwona Zdybska

Lublin, Poland, 20-607

Actively Recruiting

65

Twoja Przychodnia - Medyczne Nowa Sol

Nowa Sól, Poland, 67-100

Actively Recruiting

66

Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski

Osielsko, Poland, 86-031

Actively Recruiting

67

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, Poland, 27-400

Withdrawn

68

Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

Rzeszów, Poland, 35-055

Actively Recruiting

69

Twoja Przychodnia Scm

Szczecin, Poland, 71-500

Actively Recruiting

70

Evimed Sp. Z O. O.

Warsaw, Poland, 02-625

Actively Recruiting

71

Centro Hospitalar E Universitario Coimbra

Coimbra, Portugal, 3000-602

Not Yet Recruiting

72

Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos

Lisbon, Portugal, 1169-050

Not Yet Recruiting

73

Hospital Geral de Santo Antonio

Porto, Portugal, 4099-001

Actively Recruiting

74

Hospital Universitario Fundacion Alcorcon

Alcorcón, Spain, 28922

Actively Recruiting

75

Hospital Universitari Germans Trias I Pujol

Badalona, Spain, 08916

Actively Recruiting

76

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain, 08026

Actively Recruiting

77

Hospital Sant Joan de Deu Barcelona

Esplugues de Llobregat, Spain, 08950

Actively Recruiting

78

Hospital Infantil Unversitario Nino Jesus

Madrid, Spain, 28009

Actively Recruiting

79

Hospital Universitario Miguel Servet de Zaragoza

Zaragoza, Spain, 50009

Actively Recruiting

80

Croydon University Hospital

Croydon, United Kingdom, CR7 7YE

Not Yet Recruiting

81

The Royal London Hospital - Barts Health Nhs Trust

London, United Kingdom, E1 1FR

Not Yet Recruiting

82

Guys Hospital

London, United Kingdom, SE1 9RT

Not Yet Recruiting

83

Great Ormond Street Hospital For Children Nhs Foundation Trust

London, United Kingdom, WC1N 3JH

Not Yet Recruiting

84

Queen'S Medical Centre - Nottingham University Hospitals Nhs Trust

Nottingham, United Kingdom, NG7 2UH

Not Yet Recruiting

85

Sheffield Childrens Hospital

Sheffield, United Kingdom, S10 2TH

Not Yet Recruiting

86

Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust

Walsall, United Kingdom, WS2 9PS

Not Yet Recruiting

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Research Team

I

Incyte Corporation Call Center (US)

CONTACT

I

Incyte Corporation Call Center (ex-US)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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