Actively Recruiting
A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study 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
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of ruxolitinib cream in children aged 6 to under 12 years who have nonsegmental vitiligo, a condition causing patches of skin to lose pigment. This phase 3 randomized, double-blind study aims to determine how well this topical treatment improves the appearance of vitiligo, especially on the face, while monitoring safety and side effects. Participants are randomly assigned to one of three groups to receive either ruxolitinib cream at 0.75% or 1.5% strength, or a matching placebo cream (vehicle). The cream is applied twice daily as a thin film to affected areas defined by the study protocol. The treatment lasts for 24 weeks, during which the response to therapy will be assessed. The study includes a safety follow-up period extending up to 52 weeks to monitor for any treatment-related adverse events. Throughout the study, children will have their vitiligo area scored using facial and total body Vitiligo Area Scoring Index (F-VASI and T-VASI) at multiple time points. Additional assessments include patient and caregiver impressions of change, quality of life measures, psychosocial impact questionnaires, and pharmacokinetic blood sampling. The main outcome focuses on the proportion of participants achieving at least a 75% improvement in facial vitiligo at 24 weeks. Safety and treatment satisfaction will also be evaluated, with total participation lasting up to one year including follow-up.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Aged 6 to less than 12 years at the time of signing the informed consent form.
- Clinical diagnosis of nonsegmental vitiligo with depigmented area including at least 0.5% body surface area on the face, at least 0.5 facial vitiligo area scoring index, at least 3% body surface area on nonfacial areas, and at least 3 total body vitiligo area scoring index.
- Total body vitiligo area does not exceed 10% body surface area.
- Presence of pigmented hair within some of the vitiligo areas on the face.
- Agree to stop all other 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.
You will not qualify if you...
- Diagnosis of other forms of vitiligo such as segmental vitiligo.
- Other skin depigmentation disorders including piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor.
- Any other skin disease that may interfere with study cream application or assessments.
- Prior or current use of depigmentation treatments like monobenzone.
- Presence of other defined concurrent conditions or serious illnesses that interfere with participation or pose risk.
- Use of certain treatments within required washout period before baseline.
- History of treatment failure with any systemic or topical JAK inhibitor.
- Clinically significant abnormal lab values at screening.
- Body mass index-for-age below 5th percentile or above 85th percentile.
- Pregnant or lactating participants or those planning pregnancy during study participation.
- Inability or unlikely to comply with cream 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 to any component of the study cream.
- Specific exclusions for participants in France and the European Union as per local regulations.
- Other protocol-defined inclusion or exclusion criteria may apply.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants apply ruxolitinib cream or matching vehicle cream topically to the affected areas twice daily as defined in the protocol.
Regular visits throughout treatment period
Duration - Up to 28 weeks after treatment
Participants are monitored for safety and efficacy outcomes after treatment ends.
Visits at Weeks 30 and 52
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
Research Team
I
Incyte Corporation Call Center (US)
I
Incyte Corporation Call Center (ex-US)
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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