Clinical trial • Phase III • Dermatology
RUXOLITINIB for Vitiligo
Phase III trial of RUXOLITINIB for Vitiligo.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Vitiligo
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 30-04-2025
- First CTIS Authorization Date
- 20-08-2025
Trial design
Randomised, vehicle (placebo) cream bid (vehicle cream bid) as the placebo comparator; active arms: ruxolitinib 0.75% cream bid and ruxolitinib 1.5% cream bid.-controlled Phase III trial across 66 sites in France, Spain, Bulgaria and others.
- Randomised
- Yes
- Comparator
- Vehicle (placebo) cream BID (vehicle cream BID) as the placebo comparator; active arms: ruxolitinib 0.75% cream BID and ruxolitinib 1.5% cream BID.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 48
- Trial Duration For Participant
- 364
Eligibility
Recruits 48 paediatric patients.
- Pregnancy Exclusion
- Pregnant or lactating or considering pregnancy during the period of study participation
- Vulnerable Population
- Participants are pediatric (aged 6 to <12 years). Informed consent must be provided by the legally designated representative (parent/legal guardian) and the child must provide a verbal or written assent when possible. Country- and age-specific informed consent and assent documents are provided (parent/guardian ICF and assent forms for ages 6–11). Specific exclusions apply to vulnerable populations in France per French Public Health Code and to participants considered incapacitated in the EU per EU CTR Articles 2 and 31. Optional photography and additional participant-facing materials and age-appropriate 'Know the Child' booklets are provided; assent processes and parent/legal representative consent are described in the study documentation.
Inclusion criteria
- {"criterion_text":"- Ability to comprehend and willingness to sign an ICF or written informed consent of the legally designated representative and a verbal or written assent from the participant when possible\n- Aged 6 to < 12 years at the time of signing the ICF\n- 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\n- Total body vitiligo area (facial and nonfacial) does not exceed 10% BSA\n- Pigmented hair within some of the areas of vitiligo on the face\n- Must agree to discontinue all agents used to treat vitiligo from screening through the safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted as per Section 6.6.1.\n- With the exception of participants who are prepubescent, willingness to avoid pregnancy or fathering children based on the criteria below. Permitted methods in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed. a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last application of study cream. b. Female participants who have reached menarche must have a negative urine pregnancy test at screening and before the first application of study cream on Day 1 (if the interval between screening and Day 1 is > 2 weeks) and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last application of study cream."}
Exclusion criteria
- {"criterion_text":"- Diagnosis of other forms of vitiligo (eg, segmental)\n- Other differential diagnosis of vitiligo or other skin depigmentation disorder (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor)\n- Any other skin disease that, in the opinion of the investigator, would interfere with study cream application or study assessments\n- Prior or current use of depigmentation treatments (eg, monobenzone)\n- Concurrent conditions and history of other diseases as follows: a. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). b. History of malignant disease within 5 years before the Day 1 visit, except for adequately treated, nonmetastatic, nonmelanoma, skin cancer. c. Current and/or history of thrombosis, including deep venous thrombosis and pulmonary embolism. d. Current and/or history of liver disease, including known hepatitis B or C virus infection, with hepatic or biliary abnormalities. e. Current and/or history of HIV infection. f. Current and/or history of active tuberculosis; or current and/or history of latent tuberculosis unless adequately treated.\n- 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. Examples include but are not limited to the following: a. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Day 1 visit. b. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, impetigo) within 1 week before the Day 1 visit. c. Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months before the Day 1 visit; New York Heart Association Class III or IV congestive heart failure; or arrhythmia requiring therapy or uncontrolled hypertension (blood pressure > 150/90 mmHg), unless approved by the medical monitor/sponsor. d. On maintenance dialysis. e. Committed to an institution by virtue of an order issued by either judicial or administrative authorities\n- Use of any of the following treatments within the indicated washout period before Day 1: a. 1 week: Topical drugs (eg, corticosteroids, calcineurin and phosphodiesterase type 4 inhibitors, and retinoids) when used on the vitiligo areas. b. 2 weeks: Immunizations with live-attenuated vaccines. Note: Live-attenuated vaccines are not recommended during the double-blind, vehicle-controlled period. c. 4 weeks: − Melanocyte-stimulating agents (eg, afamelanotide). − Immunomodulating systemic medications (eg, corticosteroids, methotrexate, and cyclosporine). − Any other systemic therapies that could increase the skin sensitivity to UV/visible light or impact skin pigmentation (eg, tetracyclines and methoxypsoralens). d. 8 weeks: Laser or any kind of phototherapy, including tanning bed or intentional UV exposure. e. 5 half-lives or 12 weeks, whichever is longer, for any of the following if used to treat vitiligo: Biologic agents, investigational therapies, experimental therapies, or procedures. Investigational biologic agents should be discussed with the sponsor to determine whether a longer period of discontinuation is required\n- The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code\n- In the EU, participants considered incapacitated according to EU CTR No. 536/2014 Articles 2 and 31\n- Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study\n- Employees of the sponsor or investigator or are otherwise dependents of them\n- Known allergy or reaction to any component of the study cream formulation\n- History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition\n- Any of the following clinically significant, abnormal laboratory values at screening: a. Cytopenias: − Hemoglobin < 10 g/dL − Absolute neutrophil count < 1500/µL − Platelet count < 100,000/µL b. Liver function tests: − AST or ALT ≥ 2 × ULN − ALP and/or bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is < 35%) c. Estimated glomerular filtration rate < 30 mL/min/1.73 m (using the Revised (bedside) Schwartz equation). d. Clinically significant, abnormal TSH or free T4 as determined by the investigator. e. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants achieving F-VASI75 at Week 24","definition_or_measurement_approach":"Assessed by F-VASI (Facial Vitiligo Area Scoring Index) at Week 24; primary endpoint is proportion achieving F-VASI75 (as stated: F-VASI75 at Week 24)."}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants achieving F-VASI50 at Week 24","definition_or_measurement_approach":"Assessed by F-VASI at Week 24."}
- {"endpoint_text":"- Proportion of participants achieving F-VASI90 at Week 24","definition_or_measurement_approach":"Assessed by F-VASI at Week 24."}
- {"endpoint_text":"- Proportion of participants achieving T-VASI50 at Week 24","definition_or_measurement_approach":"Assessed by T-VASI (Total Vitiligo Area Scoring Index) at Week 24."}
- {"endpoint_text":"- Percentage change from baseline in F-BSA at Week 24","definition_or_measurement_approach":"Change from baseline in facial body surface area affected (F-BSA) at Week 24."}
- {"endpoint_text":"- AEs, assessed by changes in vital signs, clinical evaluations, height, weight, and laboratory data","definition_or_measurement_approach":"Safety assessed by adverse events and changes in vital signs, clinical evaluations, height, weight, and laboratory tests."}
- {"endpoint_text":"- Proportion of participants achieving a VNS score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Weeks 24 and 52","definition_or_measurement_approach":"Patient- or rater-reported VNS (Visibility/Noticeability) score measured at Weeks 24 and 52."}
- {"endpoint_text":"- Proportion of participants in each category for the color-matching question at Weeks 24 and 52","definition_or_measurement_approach":"Distribution of responses to the color-matching question at Weeks 24 and 52."}
- {"endpoint_text":"- Proportion of participants who report F-PaGIC-V of very much improved or much improved at Weeks 24 and 52","definition_or_measurement_approach":"F-PaGIC-V (facial Paediatric Global Impression of Change for Vitiligo) patient-reported improvement categories at Weeks 24 and 52."}
- {"endpoint_text":"- Proportion of participants who report T-PaGIC-V of very much improved or much improved at Weeks 24 and 52","definition_or_measurement_approach":"T-PaGIC-V (total body Paediatric Global Impression of Change for Vitiligo) patient-reported improvement categories at Weeks 24 and 52."}
- {"endpoint_text":"- Change from baseline in VIT-PIQ at Weeks 24 and 52","definition_or_measurement_approach":"Change from baseline in VIT-PIQ instrument at Weeks 24 and 52."}
- {"endpoint_text":"- Change from baseline in CDLQI at Weeks 24 and 52","definition_or_measurement_approach":"Change from baseline in Children's Dermatology Life Quality Index (CDLQI) at Weeks 24 and 52."}
- {"endpoint_text":"- Change from baseline in PGIB-V at Weeks 24 and 52","definition_or_measurement_approach":"Change from baseline in PGIB-V instrument at Weeks 24 and 52."}
- {"endpoint_text":"- Mean satisfaction score at Weeks 24 and 52","definition_or_measurement_approach":"Participant satisfaction score averaged at Weeks 24 and 52."}
- {"endpoint_text":"- Preapplication plasma concentrations of ruxolitinib at Weeks 4, 24, 40, and 52","definition_or_measurement_approach":"Pharmacokinetic measurements: pre-application plasma concentrations of ruxolitinib at specified weeks (4, 24, 40, 52)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 48
- Recruitment Window Months
- 25
- Consent Approach
- Informed consent must be provided by the legally designated representative (parent/legal guardian). Children aged 6 to <12 provide a verbal or written assent when possible. Country- and language-specific parent/guardian ICFs and child assent documents are provided (multiple language versions: English, French, Spanish, Dutch, Italian, Portuguese, Bulgarian, Hungarian, German, Polish, etc.). Optional photography consent and pregnancy-related information for parent/guardian/participant are provided as separate documents. The study uses site-based consent procedures with supplied materials (ICF flipbook and age-appropriate booklets) and central IRT for randomization.
Methods
- Patient-facing printed materials (K2 brochures, flyers, patient letters) distributed at participating clinics and hospitals in local languages (country-specific brochures/flyers listed for FR, ES, BG, NL, IT, PT, DE, PL, HU, etc.).
- ICF Flipbook and age-appropriate subject materials (e.g., 'Know the Child' booklets, appointment reminder cards, study visit guides) provided to parents/legal guardians and pediatric participants at sites.
- Online postings and digital recruitment (K2_Online Posting, country-specific online postings such as 'Online Posting_Sanos' for Denmark) to reach caregivers/parents and patient communities.
- GP/primary care outreach (GP letters) and site referral: materials include GP letters and clinic-based recruitment via dermatology/pediatric departments at listed hospitals.
- Patient newsletter and appointment reminder communications distributed to potential participants or referral networks.
- Site-based recruitment via participating hospitals, dermatology clinics and pediatric centers across member states (site contact details provided).
Geography
- Total Number Of Sites
- 66
- Total Number Of Participants
- 202
France
- Earliest CTIS Part Ii Submission Date
- 08-07-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 233
- Number Of Sites
- 10
- Number Of Participants
- 21
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Dermatology department
- Principal Investigator Name
- Cécile Lesort
- Principal Investigator Email
- cecile.lesort@chu-lyon.fr
- Contact Person Name
- Cécile Lesort
- Contact Person Email
- cecile.lesort@chu-lyon.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Dermatology department
- Principal Investigator Name
- Khaled Ezzedine
- Principal Investigator Email
- khaled.ezzedine@aphp.fr
- Contact Person Name
- Khaled Ezzedine
- Contact Person Email
- khaled.ezzedine@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Dermatology department
- Principal Investigator Name
- Sebastien Barbarot
- Principal Investigator Email
- Sebastien.barbarot@chu-nantes.fr
- Contact Person Name
- Sebastien Barbarot
- Contact Person Email
- Sebastien.barbarot@chu-nantes.fr
- Site Name
- Centre Hospitalier Victor Dupouy
- Department Name
- Dermatology department
- Principal Investigator Name
- Emmanuel Mahe
- Principal Investigator Email
- emmanuel.mahe@ch-argenteuil.fr
- Contact Person Name
- Emmanuel Mahe
- Contact Person Email
- emmanuel.mahe@ch-argenteuil.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Dermatology pediatric department
- Principal Investigator Name
- Christine Labreze
- Principal Investigator Email
- christine.labreze@chu-bordeaux.fr
- Contact Person Name
- Christine Labreze
- Contact Person Email
- christine.labreze@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Dermatology department
- Principal Investigator Name
- Maella Severino-Freire
- Principal Investigator Email
- Severino-freire.m@chu-toulouse.fr
- Contact Person Name
- Maella Severino-Freire
- Contact Person Email
- Severino-freire.m@chu-toulouse.fr
- Site Name
- CHRU De Nancy
- Department Name
- Dermatology department
- Principal Investigator Name
- Anne Claire Bursztejn
- Principal Investigator Email
- ac.bursztejn@chru-nancy.fr
- Contact Person Name
- Anne Claire Bursztejn
- Contact Person Email
- ac.bursztejn@chru-nancy.fr
- Site Name
- Courlancy Sante
- Department Name
- Dermatology department
- Principal Investigator Name
- Ziad REGUIAI
- Principal Investigator Email
- dr-reguiai@orange.fr
- Contact Person Name
- Ziad REGUIAI
- Contact Person Email
- dr-reguiai@orange.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Dermatology department
- Principal Investigator Name
- Smaïl Hadj-Rabia
- Principal Investigator Email
- smail.hadj@inserm.fr
- Contact Person Name
- Smaïl Hadj-Rabia
- Contact Person Email
- smail.hadj@inserm.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Dermatology department
- Principal Investigator Name
- Thierry Passeron
- Principal Investigator Email
- Passeron.t@chu-nice.fr
- Contact Person Name
- Thierry Passeron
- Contact Person Email
- Passeron.t@chu-nice.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 06-03-2026
- Processing Time Days
- 221
- Number Of Sites
- 6
- Number Of Participants
- 18
Sites
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Dermatology
- Principal Investigator Name
- Lucero Noguera Morel
- Principal Investigator Email
- luceronoguera@gmail.com
- Contact Person Name
- Lucero Noguera Morel
- Contact Person Email
- luceronoguera@gmail.com
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Dermatology
- Principal Investigator Name
- Fermina Yolanda Gilaberte Calzada
- Principal Investigator Email
- ygilaberte@salud.aragon.es
- Contact Person Name
- Fermina Yolanda Gilaberte Calzada
- Contact Person Email
- ygilaberte@salud.aragon.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Dermatology
- Principal Investigator Name
- Isabel Bielsa Marsol
- Principal Investigator Email
- ibielsa.germanstrias@gencat.cat
- Contact Person Name
- Isabel Bielsa Marsol
- Contact Person Email
- ibielsa.germanstrias@gencat.cat
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- Dermatology
- Principal Investigator Name
- Jose Luis Lopez Estebaranz
- Principal Investigator Email
- jlestebaranz@salud.madrid.org
- Contact Person Name
- Jose Luis Lopez Estebaranz
- Contact Person Email
- jlestebaranz@salud.madrid.org
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Dermatology
- Principal Investigator Name
- Eulalia Baselga Torres
- Principal Investigator Email
- eulalia.baselga@sjd.es
- Contact Person Name
- Eulalia Baselga Torres
- Contact Person Email
- eulalia.baselga@sjd.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Dermatology
- Principal Investigator Name
- Esther Roé Crespo
- Principal Investigator Email
- dermatologia@santpau.cat
- Contact Person Name
- Esther Roé Crespo
- Contact Person Email
- dermatologia@santpau.cat
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 260
- Number Of Sites
- 7
- Number Of Participants
- 24
Sites
- Site Name
- Diagnostic And Consulting Center XXVIII-Sofia EOOD
- Principal Investigator Name
- Katya Zaharieva
- Principal Investigator Email
- Zaharieva_doctor@abv.bg
- Contact Person Name
- Katya Zaharieva
- Contact Person Email
- Zaharieva_doctor@abv.bg
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- Principal Investigator Name
- Petyo Brezoev
- Principal Investigator Email
- drbrezoev@abv.bg
- Contact Person Name
- Petyo Brezoev
- Contact Person Email
- drbrezoev@abv.bg
- Site Name
- Diagnostic Consultation Center XX-Sofia EOOD
- Principal Investigator Name
- Toma Tomov
- Principal Investigator Email
- Dr.toma.tomov@abv.bg
- Contact Person Name
- Toma Tomov
- Contact Person Email
- Dr.toma.tomov@abv.bg
- Site Name
- Asclepius Medical Center OOD
- Principal Investigator Name
- Boyka Stoyanova
- Principal Investigator Email
- Dr.Boyka.stoyanova@gmail.com
- Contact Person Name
- Boyka Stoyanova
- Contact Person Email
- Dr.Boyka.stoyanova@gmail.com
- Site Name
- Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD
- Department Name
- Department of Skin and Venereal Diseases
- Principal Investigator Name
- Krasimira Yordzheva
- Principal Investigator Email
- Dr.yordzheva@gmail.com
- Contact Person Name
- Krasimira Yordzheva
- Contact Person Email
- Dr.yordzheva@gmail.com
- Site Name
- UNIMED Medical Center EOOD
- Principal Investigator Name
- Marina Sankeva
- Principal Investigator Email
- Dr_sankeva@abv.bg
- Contact Person Name
- Marina Sankeva
- Contact Person Email
- Dr_sankeva@abv.bg
- Site Name
- Ambulatoria Za Specializirana Medicinska Pomosht-Grupova Praktika Po Dermatologia Clinica Evroderma OOD
- Principal Investigator Name
- Mariela Hitova
- Principal Investigator Email
- mail@drhitova.com
- Contact Person Name
- Mariela Hitova
- Contact Person Email
- mail@drhitova.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 02-07-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 250
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- University Of Pecs
- Department Name
- Bőr- Nemikórtani és Onkodermatológiai Klinika
- Principal Investigator Name
- Adriana Evelin Csernus
- Principal Investigator Email
- csernus.adriana@pte.hu
- Contact Person Name
- Adriana Evelin Csernus
- Contact Person Email
- csernus.adriana@pte.hu
- Site Name
- University Of Debrecen
- Department Name
- Bőrgyógyászati Klinika
- Principal Investigator Name
- Andrea Szegedi
- Principal Investigator Email
- aszegedi@med.unideb.hu
- Contact Person Name
- Andrea Szegedi
- Contact Person Email
- aszegedi@med.unideb.hu
- Site Name
- University Of Szeged
- Department Name
- Bőrgyógyászati és Allergológiai Klinika
- Principal Investigator Name
- Zsanett Renata Csoma
- Principal Investigator Email
- csomazs@mail.derma.szote.u-szeged.hu
- Contact Person Name
- Zsanett Renata Csoma
- Contact Person Email
- csomazs@mail.derma.szote.u-szeged.hu
- Site Name
- Clinexpert Kft.
- Department Name
- Clinexpert Obuda Egeszsegcentruma
- Principal Investigator Name
- Dorottya Asboth
- Principal Investigator Email
- dr.asboth.dorottya@gmail.com
- Contact Person Name
- Dorottya Asboth
- Contact Person Email
- dr.asboth.dorottya@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 14-08-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 200
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Dermatology
- Principal Investigator Name
- Sanne Uitentuis
- Principal Investigator Email
- s.e.uitentuis@amsterdamumc.nl
- Contact Person Name
- Sanne Uitentuis
- Contact Person Email
- s.e.uitentuis@amsterdamumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 25-07-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 222
- Number Of Sites
- 9
- Number Of Participants
- 27
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Department of Medical and Surgical Sciences
- Principal Investigator Name
- Iria Neri
- Principal Investigator Email
- Iria.neri@aosp.bo.it
- Contact Person Name
- Iria Neri
- Contact Person Email
- Iria.neri@aosp.bo.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- UO Dermatologia
- Principal Investigator Name
- Riccardo Cavalli
- Principal Investigator Email
- riccardo.cavalli@policlinico.mi.it
- Contact Person Name
- Riccardo Cavalli
- Contact Person Email
- riccardo.cavalli@policlinico.mi.it
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- Dermatology Unit
- Principal Investigator Name
- Dario Francesco D’Urso
- Principal Investigator Email
- dariofrancesco.durso@opbg.net
- Contact Person Name
- Dario Francesco D’Urso
- Contact Person Email
- dariofrancesco.durso@opbg.net
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Dipartimento di Sanità Pubblica, Farmacoutilizzazione e Dermatologia
- Principal Investigator Name
- Maddalena Napolitano
- Principal Investigator Email
- maddalena.napolitano@unina.it
- Contact Person Name
- Maddalena Napolitano
- Contact Person Email
- maddalena.napolitano@unina.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Dipartimento della salute della Donna e del Bambino
- Principal Investigator Name
- Anna Belloni Fortina
- Principal Investigator Email
- anna.bellonifortina@aopd.veneto.it
- Contact Person Name
- Anna Belloni Fortina
- Contact Person Email
- anna.bellonifortina@aopd.veneto.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
- Department Name
- UOC Dermatologia
- Principal Investigator Name
- Giuseppe Micali
- Principal Investigator Email
- giuseppe.micali@unict.it
- Contact Person Name
- Giuseppe Micali
- Contact Person Email
- giuseppe.micali@unict.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Dermatologia
- Principal Investigator Name
- Ketty Peris
- Principal Investigator Email
- Kitty.peris@unicatt.it
- Contact Person Name
- Ketty Peris
- Contact Person Email
- Kitty.peris@unicatt.it
- Site Name
- Fondazione Luigi Maria Monti
- Department Name
- Clinical Dermatology
- Principal Investigator Name
- Mauro Picardo
- Principal Investigator Email
- m.picardo@idi.it
- Contact Person Name
- Mauro Picardo
- Contact Person Email
- m.picardo@idi.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Unità di Dermatologia
- Principal Investigator Name
- Mariachiara Arisi
- Principal Investigator Email
- dermatologia@asst-spedalicivili.it
- Contact Person Name
- Mariachiara Arisi
- Contact Person Email
- dermatologia@asst-spedalicivili.it
Denmark
- Earliest CTIS Part Ii Submission Date
- 15-08-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 195
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Sanos A/S
- Department Name
- Gandrup
- Principal Investigator Name
- Cecilie Rovsing
- Principal Investigator Email
- info.nordjylland@sanosclinic.com
- Contact Person Name
- Cecilie Rovsing
- Contact Person Email
- info.nordjylland@sanosclinic.com
- Site Name
- Gentofte Hospital
- Department Name
- Department of Dermatology and Allergy
- Principal Investigator Name
- Lone Skov
- Principal Investigator Email
- Lone.skov.02@regionh.dk
- Contact Person Name
- Lone Skov
- Contact Person Email
- Lone.skov.02@regionh.dk
Portugal
- Earliest CTIS Part Ii Submission Date
- 23-06-2025
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 249
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Pediatrics
- Principal Investigator Name
- Maria João Lopes
- Principal Investigator Email
- maria.lopes14@ulssjose.min-saude.pt
- Contact Person Name
- Maria João Lopes
- Contact Person Email
- maria.lopes14@ulssjose.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Pediatrics
- Principal Investigator Name
- Leonor Ramos
- Principal Investigator Email
- leonoricr@gmail.com
- Contact Person Name
- Leonor Ramos
- Contact Person Email
- leonoricr@gmail.com
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Dermatology
- Principal Investigator Name
- Susana Machado
- Principal Investigator Email
- susanamachado.dermatologia@chporto.min-saude.pt
- Contact Person Name
- Susana Machado
- Contact Person Email
- susanamachado.dermatologia@chporto.min-saude.pt
Austria
- Earliest CTIS Part Ii Submission Date
- 10-07-2025
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 260
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Medizinische Universität Graz
- Department Name
- Dermatology and Venereology
- Principal Investigator Name
- Angelika Hofer
- Principal Investigator Email
- Angelika.hofer@medunigraz.at
- Contact Person Name
- Angelika Hofer
- Contact Person Email
- Angelika.hofer@medunigraz.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Dermatology, Venerology and Allergy
- Principal Investigator Name
- Matthias Schmuth
- Principal Investigator Email
- matthias.schmuth@imed.ac.at
- Contact Person Name
- Matthias Schmuth
- Contact Person Email
- matthias.schmuth@imed.ac.at
Belgium
- Earliest CTIS Part Ii Submission Date
- 25-07-2025
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 221
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- UZ Leuven
- Department Name
- Dermatology
- Principal Investigator Name
- Caroline Colmant
- Principal Investigator Email
- caroline.colmant@uzleuven.be
- Contact Person Name
- Caroline Colmant
- Contact Person Email
- caroline.colmant@uzleuven.be
- Site Name
- Hopital Erasme
- Department Name
- Dermatology
- Principal Investigator Name
- Véronique Del Marmol
- Principal Investigator Email
- veronique.delmarmol@hubruxelles.be
- Contact Person Name
- Véronique Del Marmol
- Contact Person Email
- veronique.delmarmol@hubruxelles.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Dermatology
- Principal Investigator Name
- Reinhart Speeckaert
- Principal Investigator Email
- reinhart.speeckaert@uzgent.be
- Contact Person Name
- Reinhart Speeckaert
- Contact Person Email
- reinhart.speeckaert@uzgent.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Dermatology
- Principal Investigator Name
- Pierre-Dominique Ghislain
- Principal Investigator Email
- pierre-dominique.ghislain@saintluc.uclouvain.be
- Contact Person Name
- Pierre-Dominique Ghislain
- Contact Person Email
- pierre-dominique.ghislain@saintluc.uclouvain.be
Germany
- Earliest CTIS Part Ii Submission Date
- 07-08-2025
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 204
- Number Of Sites
- 9
- Number Of Participants
- 30
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Ulrike BLUME-PEYTAVI
- Principal Investigator Email
- ulrike.blume-peytavi@charite.de
- Contact Person Name
- Ulrike BLUME-PEYTAVI
- Contact Person Email
- ulrike.blume-peytavi@charite.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Klinik und Poliklinik für Dermatologie und Allergologie
- Principal Investigator Name
- Carola BERKING
- Principal Investigator Email
- carola.berking@uk-erlangen.de
- Contact Person Name
- Carola BERKING
- Contact Person Email
- carola.berking@uk-erlangen.de
- Site Name
- Katholisches Kinderkrankenhaus Wilhelmstift gGmbH
- Department Name
- Pädiatrie und Pädiatrische Dermatologie / Allergologie
- Principal Investigator Name
- Peter H. HOEGER
- Principal Investigator Email
- p.hoeger@kkh-wilhelmstift.de
- Contact Person Name
- Peter H. HOEGER
- Contact Person Email
- p.hoeger@kkh-wilhelmstift.de
- Site Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Department Name
- Pädiatrische Dermatologie und atopisches Ekzem/Neurodermitis
- Principal Investigator Name
- Christina SCHNOPP
- Principal Investigator Email
- christina.schnopp@tum.de
- Contact Person Name
- Christina SCHNOPP
- Contact Person Email
- christina.schnopp@tum.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Dermatologie
- Principal Investigator Name
- Dora STOELZL
- Principal Investigator Email
- dstoelzl@dermatology.uni-kiel.de
- Contact Person Name
- Dora STOELZL
- Contact Person Email
- dstoelzl@dermatology.uni-kiel.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Hautklinik und Poliklinik
- Principal Investigator Name
- Petra STAUBACH-RENZ
- Principal Investigator Email
- petra.staubach@unimedizin-mainz.de
- Contact Person Name
- Petra STAUBACH-RENZ
- Contact Person Email
- petra.staubach@unimedizin-mainz.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Jan C. SIMON
- Principal Investigator Email
- jan.simon@medizin.uni-leipzig.de
- Contact Person Name
- Jan C. SIMON
- Contact Person Email
- jan.simon@medizin.uni-leipzig.de
- Site Name
- Universitaet Muenster
- Department Name
- Dermatologie
- Principal Investigator Name
- Nina MAGNOLO
- Principal Investigator Email
- nina.magnolo@ukmuenster.de
- Contact Person Name
- Nina MAGNOLO
- Contact Person Email
- nina.magnolo@ukmuenster.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (additional entry)
- Department Name
- Dermatology (listed sites include several university hospitals)
Poland
- Earliest CTIS Part Ii Submission Date
- 13-08-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 201
- Number Of Sites
- 9
- Number Of Participants
- 31
Sites
- Site Name
- Diamond Clinic Sp. z o.o.
- Department Name
- Diamond Medical Center
- Principal Investigator Name
- Barbara Rewerska
- Principal Investigator Email
- biuro@diamondclinic.eu
- Contact Person Name
- Barbara Rewerska
- Contact Person Email
- biuro@diamondclinic.eu
- Site Name
- Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
- Department Name
- Klinika Dermatologii i Dermatologii Onkologicznej
- Principal Investigator Name
- Adam Reich
- Principal Investigator Email
- adamandrzejreich@gmail.com
- Contact Person Name
- Adam Reich
- Contact Person Email
- adamandrzejreich@gmail.com
- Site Name
- DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.
- Principal Investigator Name
- Rafal Czajkowski
- Principal Investigator Email
- r.czajkowski@dermodent.pl
- Contact Person Name
- Rafal Czajkowski
- Contact Person Email
- r.czajkowski@dermodent.pl
- Site Name
- Care Clinic Sp. z o.o.
- Department Name
- Care Clinic Centrum Medyczne
- Principal Investigator Name
- Dominika Wcislo-Dziadecka
- Principal Investigator Email
- poczta@careclinic.katowice.pl
- Contact Person Name
- Dominika Wcislo-Dziadecka
- Contact Person Email
- poczta@careclinic.katowice.pl
- Site Name
- Dermedic Iwona Zdybska
- Department Name
- NZOZ Dermedic Iwona Zdybska
- Principal Investigator Name
- Katarzyna Wolska-Gawron
- Principal Investigator Email
- katarzyna.wolska@zdybski.pl
- Contact Person Name
- Katarzyna Wolska-Gawron
- Contact Person Email
- katarzyna.wolska@zdybski.pl
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Department Name
- Centrum Badan Klinicznych PIHouse
- Principal Investigator Name
- Aleksandra Okuniewska
- Principal Investigator Email
- pihouse@pihouse.pl
- Contact Person Name
- Aleksandra Okuniewska
- Contact Person Email
- pihouse@pihouse.pl
- Site Name
- Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
- Principal Investigator Name
- Anna Kacalak-Rzepka
- Principal Investigator Email
- ncm@twojaprzychodnia.com
- Contact Person Name
- Anna Kacalak-Rzepka
- Contact Person Email
- ncm@twojaprzychodnia.com
- Site Name
- Evimed Sp. z o.o.
- Department Name
- Centrum Medyczne EVIMED
- Principal Investigator Name
- Elzbieta Kowalska-Oledzka
- Principal Investigator Email
- rejestracja@evimed.com.pl
- Contact Person Name
- Elzbieta Kowalska-Oledzka
- Contact Person Email
- rejestracja@evimed.com.pl
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- Twoja Przychodnia SCM
- Principal Investigator Name
- Tadeusz Dębniak
- Principal Investigator Email
- hanza@twojaprzychodnia.com
- Contact Person Name
- Tadeusz Dębniak
- Contact Person Email
- hanza@twojaprzychodnia.com
Sponsor
Primary sponsor
- Full Name
- Incyte Corp.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Codes: 1,12,13,2,4,5,6 (multiple sponsor duties listed)
- Name
- ICON Clinical Research Limited Ireland Filial
- Responsibilities
- Code: 1 (sponsor duty code listed)
- Name
- Suvoda LLC
- Responsibilities
- Codes: 3,7 (sponsor duty codes listed)
Third parties
- {"country":"Italy","full_name":"Alloga (Italia) S.r.l.","duties_or_roles":"Italy Returns","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subjects reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Cyberchrome Inc.","duties_or_roles":"provider for patient materials","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duties codes: 3, 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"EU Packaging, Labeling, Storage, Returns","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Cameras / Subject Photography","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"ICON Clinical Research Limited Ireland Filial","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 1, 12, 13, 2, 4, 5, 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"equipment provider","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ruxolitinib (INCB018424) cream
- Active Substance
- RUXOLITINIB
- Modality
- Small molecule
- Routes Of Administration
- CUTANEOUS USE
- Route
- Cutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 0.75% cream BID
- Dose Levels
- 0.75% and 1.5% cream
- Frequency
- BID
- Maximum Dose
- 8.5 g per day
- Investigational Product Name
- Vehicle (placebo) cream
- Modality
- Other
- Starting Dose
- vehicle cream BID
- Dose Levels
- vehicle cream
- Frequency
- BID
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