Clinical trial • Phase III • Dermatology

RUXOLITINIB for Atopic dermatitis

Phase III trial of RUXOLITINIB for Atopic dermatitis.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Atopic dermatitis
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
06-06-2025
First CTIS Authorization Date
18-09-2025

Trial design

Randomised, vehicle cream: same formulation of cream as the test product but without active substance and phosphoric acid (vehicle-controlled comparator). dose/schedule not specified in the public record. Phase III trial across 57 sites in Germany, Italy, France and others.

Randomised
Yes
Comparator
Vehicle cream: same formulation of cream as the test product but without active substance and phosphoric acid (vehicle-controlled comparator). Dose/schedule not specified in the public record.
Target Sample Size
68

Eligibility

Recruits 68 paediatric patients.

Pregnancy Exclusion
Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
Vulnerable Population
The study population comprises children and adolescents (6 to <18 years). Informed consent must be provided by parent(s) or legal guardian (signed written ICF required). When possible, a verbal or written assent from the participant is required. Age‑appropriate assent and consent forms are provided (documents for ages 6–11 and 12–17 are included). Country-specific protections apply (for example, additional exclusions for vulnerable populations in France per French Public Health Code articles cited).

Inclusion criteria

  • {"criterion_text":"- Aged 6 to < 18 years at the VC Day 1 visit.\n- For sexually active participants, willingness to take appropriate contraceptive measures (see Appendix A of the protocol) to avoid pregnancy or fathering a child for the duration of study participation with the exception of prepubescent participants.\n- Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible. Note: A signed written ICF must be obtained for inclusion; see Section 8.1.1 and Section 8.1.2 of the protocol.\n- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.\n- AD duration of at least 3 months for 6 to 11 year olds and at least 2 years for 12 to < 18 year olds (participant/parent/guardian may verbally report signs and symptoms of AD).\n- EASI score > 7 at the screening and VC Day 1 visits.\n- IGA score of 3 at the screening and VC Day 1 visits.\n- Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20% at the screening and VC Day 1 visits.\n- Itch NRS or WI NRS score ≥ 4 at the VC Day 1 visit, defined as the average of the 7 days directly before the VC Day 1 visit, with Itch NRS or WI NRS values available for at least 4 of the 7 days.\n- Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs as specified in the protocol.\n- Agreement by participants and guardians to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit, except as outlined in Section 6.6.2 and Section 6.6.3. of the protocol"}

Exclusion criteria

  • {"criterion_text":"- Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to the VC Day 1 visit.\n- Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.\n- Known allergy or reaction to any component of the study cream formulation.\n- In the opinion of the investigator, unable or unlikely to comply with the administration schedule, study evaluations, and procedures (eg, eDiary compliance).\n- Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.\n- Employees of the sponsor, sponsor delegates (eg, contract research organizations), or investigators or are otherwise dependents of them.\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 CTR Article 31).\n- Concurrent conditions and history of other diseases as specified in the protocol (including immunocompromised states, recent infections, other concomitant skin disorders, presence of AD lesions only on hands/feet, other types of eczema within 6 months, current or history of hepatitis B or C virus infection).\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 administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n- Any of the specified clinical laboratory test results at screening (eg, Hemoglobin < 10 g/dL; ANC < 1000/µL; platelet count <100,000/µL; AST/ALT ≥ 2×ULN; ALP >1.5×ULN; bilirubin >1.5×ULN except Gilbert; eGFR <30 mL/min/1.73 m2; positive HIV serology; or other clinically significant labs per investigator).\n- Use of specified treatments within indicated washout periods before VC Day 1 visit (detailed washout requirements for biologics, systemic therapies, strong CYP3A4 inhibitors, live vaccines, etc.).\n- History of treatment failure with any systemic or topical JAK inhibitor for AD or any other inflammatory condition.\n- Ultraviolet light therapy or prolonged exposure to UV sources within 2 weeks prior to baseline or planned exposure thought to impact AD.\n- Current treatment or treatment within 30 days or 5 half-lives before baseline with another investigational medication or current enrollment in another investigational drug protocol.\n- Pregnant or lactating participants or those considering pregnancy during the period of their study participation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The binary response status of EASI75 at VC Week 8. (EASI75 response is defined as achieving ≥ 75% improvement in EASI score from baseline.)","definition_or_measurement_approach":"EASI75 response is defined as achieving ≥ 75% improvement in EASI score from baseline; measured at VC Week 8 as a binary (responder/non-responder) outcome."}

Secondary endpoints

  • {"endpoint_text":"- The binary response status of IGA-TS at VC Week 8. (IGA-TS response is defined as achieving an IGA score of 0 or 1 with ≥ 2-grade improvement from baseline.)","definition_or_measurement_approach":"IGA-TS response: IGA score of 0 or 1 with ≥ 2-grade improvement from baseline; assessed at VC Week 8 (binary outcome)."}
  • {"endpoint_text":"- The binary response status of ITCH4 at VC Week 8. (ITCH4 response is defined as achieving ≥ 4-point improvement in Itch NRS [participants aged 12 to < 18 years] or WI NRS [participants aged 6 to < 12 years] score from baseline.)","definition_or_measurement_approach":"ITCH4: ≥ 4-point improvement in Itch NRS (12 to <18 yrs) or WI-NRS (6 to <12 yrs) from baseline; assessed at VC Week 8 (binary)."}
  • {"endpoint_text":"- Time to first DE in the DC period. (Defined as responders [IGA score < 2] from the VC period or the OLE period rerandomized to proactive treatment, time to first DE, where DE is defined as IGA score of ≥ 2.)","definition_or_measurement_approach":"Time (days) from start of DC period to first disease exacerbation (DE) defined as IGA ≥ 2 among prespecified rerandomized responder populations."}
  • {"endpoint_text":"- The type, frequency, and severity of AEs and changes in vital signs, height, weight, and laboratory data for hematology and serum chemistry.","definition_or_measurement_approach":"Safety assessments: collection and categorization of AEs (type, frequency, severity), vital signs, growth measures and laboratory hematology/chemistry changes per protocol schedule."}
  • {"endpoint_text":"- The binary response status of EASI75 at each postbaseline visit except VC Week 8.","definition_or_measurement_approach":"EASI75 (≥75% improvement from baseline) assessed at each postbaseline visit (binary), excluding VC Week 8 which is primary timepoint."}
  • {"endpoint_text":"- The binary response status of IGA-TS at each postbaseline visit except VC Week 8.","definition_or_measurement_approach":"IGA-TS response (IGA 0 or 1 with ≥2-grade improvement from baseline) assessed at each postbaseline visit (binary), excluding VC Week 8."}
  • {"endpoint_text":"- The binary response status of ITCH4 at Days 2, 3, and 7 and VC Weeks 2 and 4.","definition_or_measurement_approach":"ITCH4 (≥4-point improvement in itch NRS/WI-NRS) assessed at Days 2, 3, 7 and VC Weeks 2 and 4 (binary outcomes at each listed timepoint)."}
  • {"endpoint_text":"- Time to achieve ITCH4 during the VC period.","definition_or_measurement_approach":"Time (days) from baseline to first achievement of ITCH4 (≥4-point improvement) during the vehicle-controlled period."}
  • {"endpoint_text":"- The binary response status of both EASI75 and IGA-TS at each postbaseline visit in the VC period.","definition_or_measurement_approach":"Concurrent binary achievement of EASI75 and IGA-TS at each postbaseline visit during the vehicle-controlled (VC) period."}
  • {"endpoint_text":"- The binary response status of DLQI-4 (or CDLQI-4) at VC Weeks 2, 4, and 8 (DLQI-4 (or CDLQI-4) is defined as achieving ≥ 4-point improvement in DLQI (or CDLQI) from baseline.)","definition_or_measurement_approach":"DLQI-4/CDLQI-4 response defined as ≥4-point improvement from baseline; assessed at VC Weeks 2, 4 and 8 (binary)."}
  • {"endpoint_text":"- Change from baseline at each postbaseline visit in the VC period and DC period for the following: − DLQI (or CDLQI) score − POEM score","definition_or_measurement_approach":"Continuous change from baseline in DLQI/CDLQI and POEM scores at each postbaseline visit in VC and DC periods."}
  • {"endpoint_text":"- Acceptability and tolerability assessment (exit interview/questionnaire)","definition_or_measurement_approach":"Participant exit interview/questionnaire assessing acceptability and tolerability of study treatment (qualitative/quantitative instrument per protocol)."}
  • {"endpoint_text":"- Number of DEs during the DC period.","definition_or_measurement_approach":"Count of disease exacerbation events (DE) occurring during the disease control (DC) period."}
  • {"endpoint_text":"- Amount of ruxolitinib cream used during the DC period.","definition_or_measurement_approach":"Quantitative measurement of amount (mass/grams) of ruxolitinib cream used by participant during DC period per IP accountability records."}
  • {"endpoint_text":"- Plasma concentrations of ruxolitinib and PK parameters (Ctrough,ss) at VC Week 2 and VC Week 8 assessed in at least 10 evaluable ruxolitinib-treated participants in each of the 12 to < 18 year old and 6 to < 12 years old age groups.","definition_or_measurement_approach":"Plasma PK sampling to determine ruxolitinib concentrations and steady-state trough (Ctrough,ss) at VC Week 2 and Week 8 in prespecified age groups (≥10 evaluable participants per group)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
68
Recruitment Window Months
30
Consent Approach
Written informed consent must be obtained from parent(s) or legal guardian (signed written ICF required). Participants provide verbal or written assent when possible. Age‑appropriate assent forms are provided for ages 6–11 and 12–17; ICF templates for parents/guardians and for participants turning 18 are submitted. Consent/assent materials are available in country/language‑specific versions (documents submitted for EN, FR, NL, IT, HU, PL and other local versions as part of the dossier).

Methods

  • K2_Recruitment material_One-Pager — one-page recruitment materials (documented for multiple countries/languages).
  • K2_Recruitment material_Online Advertisement / Social Ads — online advertisements / social media advertising (document titles indicate online/social channels).
  • K2_Recruitment material_ Ad-Template / Online Advertisement templates — advertising templates for recruitment (country-specific ad templates present for some MSCs).
  • K1_Recruitment and Informed consent procedure / Recruitment arrangements documents — site-level recruitment and consent procedures provided as submission documents.

Geography

Total Number Of Sites
57
Total Number Of Participants
150

Germany

Earliest CTIS Part Ii Submission Date
30-07-2025
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
184
Number Of Sites
9
Number Of Participants
23

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Zentrum für entzündliche Hauterkrankungen
Contact Person Name
Dora Stölzl
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Hautkrankheiten
Contact Person Name
Nina Magnolo
Contact Person Email
Nina.Magnolo@ukmuenster.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Undine Lippert
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Hautklinik und Poliklinik
Contact Person Name
Petra Staubach-Renz
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik und Poliklinik für Dermatologie und Allergologie
Contact Person Name
Laura Maintz
Contact Person Email
laura.maintz@ukbonn.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Dermatologie
Contact Person Name
Roland Aschoff
Contact Person Email
roland.aschoff@ukdd.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Dermatologie
Contact Person Name
Athanasios Tsianakas
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas Pinter
Site Name
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen
Department Name
Hautklinik
Contact Person Name
Martin Kaatz
Contact Person Email
kaatz.martin@drk-khs.de

Italy

Earliest CTIS Part Ii Submission Date
21-08-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
187
Number Of Sites
5
Number Of Participants
9

Sites

Site Name
Universita Degli Studi Di Padova
Department Name
Department of Woman's and Children's Health SDB
Contact Person Name
Anna Belloni Fortina
Contact Person Email
anna.bellonifortina@unipd.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Department of Medicine and Surgery
Contact Person Name
Maddalena Napolitano
Contact Person Email
maddalena.napolitano@unina.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
U.O.C. Dermatologia
Contact Person Name
Giuseppe Micali
Contact Person Email
gmicalitrial@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Area Materno Infantile- SSD Dermatologia Pediatrica
Contact Person Name
Cristiana Colonna
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Dermatologia
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it

France

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
216
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Hopitaux Drome Nord
Department Name
Dermatology
Contact Person Name
François SKOWRON
Site Name
Courlancy Sante
Department Name
Dermatology and Clinical Research
Contact Person Name
Ziad REGUIAI
Contact Person Email
dr-reguiai@orange.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Dermatology
Contact Person Name
Sorilla PREY
Contact Person Email
sorilla.prey@chu-bordeaux.fr

Belgium

Earliest CTIS Part Ii Submission Date
01-09-2025
Latest Decision Or Authorization Date
17-02-2026
Processing Time Days
169
Number Of Sites
6
Number Of Participants
11

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Dermatology
Contact Person Name
Pierre-Dominique Ghislain
Site Name
Universitair Ziekenhuis Gent
Department Name
Dermatology
Contact Person Name
Sofie De Schepper
Contact Person Email
sofie.deschepper@uzgent.be
Site Name
Grand Hopital De Charleroi
Department Name
Dermatology
Contact Person Name
Pierre Paul Roquet Gravy
Site Name
Associatie dermatologie Maldegem
Department Name
Dermatology
Contact Person Name
Emma Coussens
Site Name
AZ Sint-Lucas & Volkskliniek
Department Name
Dermatology
Contact Person Name
Esther Lissens
Contact Person Email
esther.lissens@azstlucas.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Dermatology
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chuliege.be

Hungary

Earliest CTIS Part Ii Submission Date
05-08-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
192
Number Of Sites
8
Number Of Participants
28

Sites

Site Name
Clinexpert Kft.
Department Name
-
Contact Person Name
Dorottya Asbóth
Contact Person Email
dr.asboth.dorottya@gmail.com
Site Name
University Of Debrecen
Department Name
Bőrgyógyászati Klinika
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
Semmelweis Egyetem, Gyermekgyógyászati Klinika
Department Name
Bókay utcai részleg
Contact Person Name
Ádám Balogh
Contact Person Email
akkoriskareem@googlemail.com
Site Name
University Of Pecs
Department Name
Klinikai Központ, Bőr-, Nemikórtani és Onkodermatológiai Klinika
Contact Person Name
Adriána Evelin Csernus
Contact Person Email
csernus.adriana@pte.hu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Department Name
-
Contact Person Name
Judit Noll
Contact Person Email
juditnoll.clinexpert@gmail.com
Site Name
University Of Szeged
Department Name
Szent-Györgyi Albert Klinikai Központ, Bőrgyógyászati és Allergológiai Klinika
Contact Person Name
Zsanett Csoma
Contact Person Email
csoma.zsanett@med.u-szeged.hu
Site Name
Geomedical Kft.
Department Name
-
Contact Person Name
Márta Földes
Contact Person Email
drfoldesmarta@gmail.com
Site Name
Bács-Kiskun Vármegyei Oktatókórház
Department Name
Bőr- és Nemibeteg gondozó és szakrendelő
Contact Person Name
Iván Oroján
Contact Person Email
orojani@kmk.hu

Poland

Earliest CTIS Part Ii Submission Date
27-08-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
198
Number Of Sites
13
Number Of Participants
50

Sites

Site Name
Etg Warszawa Sp. z o.o.
Contact Person Name
Maria Zegadło-Mylik
Contact Person Email
m.zegadlomylik@etg-network.com
Site Name
High-Med Przychodnia Specjalistyczna
Contact Person Name
Dorota Bystrzanowska
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Contact Person Name
Michal Adamczyk
Contact Person Email
michaladamczyk1310@wp.pl
Site Name
Dermoklinika Centrum Medyczne
Contact Person Name
Joanna Narbutt
Contact Person Email
joanna.narbutt@onet.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Toruń)
Department Name
Centrum Medyczne Toruń
Contact Person Name
Aleksandra Badzian
Site Name
Medicover Integrated Clinical Services Sp. z o.o. (Warsaw)
Contact Person Name
Joanna Kolinek
Site Name
Dermmedica Sp. z o.o.
Contact Person Name
Jolanta Węgłowska
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Aleksandra Okuniewska
Contact Person Email
a.okuniewska@pihouse.pl
Site Name
Diamond Clinic Sp. z o.o.
Department Name
Diamond Medical Center
Contact Person Name
Barbara Rewerska
Contact Person Email
barbara@diamondclinic.eu
Site Name
Evimed Sp. z o.o.
Contact Person Name
Elżbieta Kowalska-Olędzka
Contact Person Email
e.kowalskaoledzka@gmail.com
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia SCM
Contact Person Name
Tadeusz Dębniak
Contact Person Email
debniak@twojaprzychodnia.com
Site Name
Centrum Medyczne All-Med Badania Kliniczne
Contact Person Name
Grażyna Pulka
Contact Person Email
allmedpl@gmail.com
Site Name
Gyncentrum Sp. z o.o.
Department Name
NZOZ Holsamed - Oddział Libero
Contact Person Name
Marcin Zakrzewski
Contact Person Email
m.zakrzewski@gyncentrum.pl

Spain

Earliest CTIS Part Ii Submission Date
16-09-2025
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
155
Number Of Sites
10
Number Of Participants
22

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Dermatology
Contact Person Name
Sara Isabel Palencia Perez
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Dermatology
Contact Person Name
Angel Manuel Rosell Diaz
Contact Person Email
aroselld@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Dermatology
Contact Person Name
Trinidad Montero Vilchez
Contact Person Email
tmonterov@gmail.com
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Dermatology
Contact Person Name
Laura Berbegal de Gracia
Contact Person Email
lauraberbegal@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Dermatology
Contact Person Name
Esther Roe Crespo
Contact Person Email
eroe@santpau.cat
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Dermatology
Contact Person Name
Eulalia Baselga Torres
Contact Person Email
eulalia.baselga@sjd.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Dermatology
Contact Person Name
Ana Batalla Cebey
Contact Person Email
ana.batalla.cebey@sergas.es
Site Name
Hospital Universitario La Paz
Department Name
Dermatology
Contact Person Name
Pedro Herranz Pinto
Contact Person Email
pherranzp@gmail.com
Site Name
Hospital De Manises
Department Name
Dermatology
Contact Person Name
Antonio Martorell Calatayud
Contact Person Email
antmarto@hotmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Dermatology
Contact Person Name
Leandro Martinez Pilar
Contact Person Email
dr.leandro.martinez@gmail.com

Sponsor

Primary sponsor

Full Name
Incyte Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Suvoda LLC
Responsibilities
Creation of eCOA Material (Assessments, Scales, Questionnaires)
Name
Icon Laboratory Services Inc.
Responsibilities
Laboratory services
Name
IQVIA Limited
Responsibilities
Vendor management, site payment, translation services, investigator recruitment, project management

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Creation of eCOA Material (Assessments, Scales, Questionnaires); contact support@suvoda.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Laboratory services (clinical lab support); contact LabSiteHelp@iconplc.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Vendor management; site payment; translation services; investigator recruitment; project management; contact eu_clinical_trials_information@iqvia.com","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 (prodAuthStatus=1; EU MP PRD10399242)
Maximum Dose
15 g per day (maxDailyDoseAmount = 15 g)
Investigational Product Name
Vehicle cream: same formulation of cream as the test product but without active substance and phosphoric acid
Modality
Other

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