A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

Status: Recruiting
Location: See all (94) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of the study is to assess the efficacy and safety of ruxolitinib cream in children and adolescents (6 to \<18 Years Old) with moderate atopic dermatitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• Aged 6 to \< 18 years at the VC Day 1 visit.

• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.

• 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).

• EASI score \> 7 at the screening and VC Day 1 visits.

• IGA score of 3 at the screening and VC Day 1 visits.

• Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20% at the screening and VC Day 1 visits.

• Itch NRS or WI NRS score ≥ 4 at the screening and VC Day 1 visits, 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.

• Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs as follows:

⁃ Inadequate response:

∙ For TCSs: Inability of a given TCS to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment for 28 days or for the maximum duration recommended by the product prescribing information (eg, 14 days for superpotent TCSs), whichever is shorter and

‣ For TCIs: Inability of a given TCI to induce and maintain remission or to contain the AD severity at an acceptable level (comparable to an IGA score of 0 \[clear\] or 1 \[almost clear\]) despite treatment according to the product prescribing information.

• Note: Documented (within 12 months before the screening visit) systemic treatment for AD (eg, oral corticosteroids, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil) or phototherapy or photo(chemo)therapy can also be considered as a surrogate for inadequate response to TCSs and TCIs.

• • Intolerance: Clinically relevant side effects, safety risks, or skin tolerability issues that outweigh the potential treatment benefits and are the reason why a topical treatment could not be restarted or continued.

• Note: Documented history (more than 12 months prior to the screening visit) of clinically significant adverse reactions with use of TCSs and/or TCIs that in the opinion of the investigator outweigh the benefits of restarting treatment would also be considered as evidence of intolerance.

• • Contraindication: As defined in the product prescribing information.

• 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 the protocol.

• For sexually active participants, willingness to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation with the exception of prepubescent participants.

• Note: Female participants who have reached menarche must have a negative urine pregnancy test at the screening and baseline visits before the first application of study cream at baseline. They must also take appropriate precautions to avoid pregnancy from the screening visit through the safety follow-up visit.

• \- 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 protocol.

Locations
United States
Alabama
Clinical Research Center of Alabama
RECRUITING
Birmingham
Arizona
Saguaro Dermatology
RECRUITING
Phoenix
Colorado
National Jewish Health
NOT_YET_RECRUITING
Denver
Florida
Encore Medical Research, Llc
NOT_YET_RECRUITING
Hollywood
Georgia
Centricity Research Lane Dermatology - Dba Iact Health Lane Dermatology Research
NOT_YET_RECRUITING
Columbus
Cleaver Medical Group
RECRUITING
Cumming
Idaho
Treasure Valley Medical Research
RECRUITING
Boise
Illinois
Sneeze Wheeze and Itch Associates Llc
RECRUITING
Normal
Endeavor Health Medical Group
NOT_YET_RECRUITING
Skokie
Maryland
Raven Clinical Research
NOT_YET_RECRUITING
Marriottsville
Michigan
Oakland Hills Dermatology
NOT_YET_RECRUITING
Auburn Hills
Henry Ford Health System
NOT_YET_RECRUITING
Detroit
Missouri
Red River Research Partners
NOT_YET_RECRUITING
Bolivar
Medisearch Clinical Trials
RECRUITING
Saint Joseph
Mississippi
University of Mississippi Medical Center
NOT_YET_RECRUITING
Jackson
New York
University of Rochester Medical Center
NOT_YET_RECRUITING
Rochester
Ohio
Cincinnati Childrens Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Texas
University of Texas Physicians - Bellaire Station
NOT_YET_RECRUITING
Bellaire
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Belgium
Cliniques Universitaires Ucl Saint-Luc
NOT_YET_RECRUITING
Brussels
Az Sint-Lucas
NOT_YET_RECRUITING
Ghent
Universitair Ziekenhuis Gent
NOT_YET_RECRUITING
Ghent
Grand Hôpital de Charleroi-Les Viviers
NOT_YET_RECRUITING
Gilly
Centre Hospitalier Universitaire de Liege - Sart Tilman
NOT_YET_RECRUITING
Liège
Dermatologie Maldegem
NOT_YET_RECRUITING
Maldegem
Canada
Dermatology Research Institute Inc.
NOT_YET_RECRUITING
Calgary
Laster Rejuvenation Clinics Edmonton D.T. Inc.
NOT_YET_RECRUITING
Edmonton
Leader Research
RECRUITING
Hamilton
Centre de Recherche Saint-Louis
NOT_YET_RECRUITING
Montreal
Chu Sainte-Justine
NOT_YET_RECRUITING
Montreal
K. Papp Clinical Research
WITHDRAWN
Ontario
Chu de Quebec Universite Laval
NOT_YET_RECRUITING
Québec
Skinsense Medical Research
RECRUITING
Saskatoon
Skincare Studio Dermatology Centre
NOT_YET_RECRUITING
St. John's
Facet Dermatology
RECRUITING
Toronto
University of British Columbia (Ubc) - British Columbia Children'S Hospital (Bc Children'S Hospital)
NOT_YET_RECRUITING
Vancouver
Winnipeg Clinic
RECRUITING
Winnipeg
France
Bordeaux Chu Hopital Saint - Andre
NOT_YET_RECRUITING
Bordeaux
Polyclinique Reims-Bezannes
NOT_YET_RECRUITING
Reims
Hopitaux Drome Nord
NOT_YET_RECRUITING
Romans-sur-isère
Germany
Fachklinik Bad Bentheim Dermatologie
NOT_YET_RECRUITING
Bad Bentheim
St. Josef-Hospital Universitaetsklinikum
NOT_YET_RECRUITING
Bochum
Universitatsklinikum Bonn Aoer
NOT_YET_RECRUITING
Bonn
Drk Krankenhaus Chemnitz-Rabenstein
NOT_YET_RECRUITING
Chemnitz
Universitaetsklinikum Carl Gustav Carus Tu Dresden
NOT_YET_RECRUITING
Dresden
Universitatsklinikum Frankfurt
NOT_YET_RECRUITING
Frankfurt
Universitatsmedizin Goettingen
NOT_YET_RECRUITING
Göttingen
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
NOT_YET_RECRUITING
Kiel
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
NOT_YET_RECRUITING
Mainz
Universitatsklinikum Munster
NOT_YET_RECRUITING
Münster
Hungary
Clinexpert Kft.
NOT_YET_RECRUITING
Budapest
Geomedical Orvosi Kft.
NOT_YET_RECRUITING
Budapest
Obudai Egeszsegugyi Centrum Kft.
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
NOT_YET_RECRUITING
Debrecen
Bacs-Kiskun Varmegyei Oktatokorhaz
NOT_YET_RECRUITING
Kecskemét
Pecsi Tudomanyegyetem
NOT_YET_RECRUITING
Pécs
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
NOT_YET_RECRUITING
Szeged
Italy
Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
NOT_YET_RECRUITING
Catania
Fondazione Irccs Ca Granda Ospedale Maggiore
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico Ii
NOT_YET_RECRUITING
Naples
Azienda Ospedale-Università Di Padova
NOT_YET_RECRUITING
Padua
Fondazione Policlinico Universitario Agostino Gemelli Irccs
NOT_YET_RECRUITING
Rome
Netherlands
Umc Utrecht
WITHDRAWN
Utrecht
Poland
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
NOT_YET_RECRUITING
Gdansk
Gyncentrum Sp. Z O.O.
NOT_YET_RECRUITING
Katowice
Centrum Medyczne All-Med Badania Kliniczne
NOT_YET_RECRUITING
Krakow
Diamond Clinic Sp. Z O.O.
NOT_YET_RECRUITING
Krakow
Dermoklinika
NOT_YET_RECRUITING
Lodz
Clinical Best Solutions Sp. Z O.O. Sp. K.
NOT_YET_RECRUITING
Lublin
Dermodent Centrum Medyczne Czajkowscy S.C.
WITHDRAWN
Osielsko
Twoja Przychodnia - Szczecinskie Centrum Medyczne
NOT_YET_RECRUITING
Szczecin
Mics Centrum Medyczne Toruń
NOT_YET_RECRUITING
Torun
Centrum Medyczne Evimed
NOT_YET_RECRUITING
Warsaw
Etg Warszawa
NOT_YET_RECRUITING
Warsaw
High-Med Przychodnia Specjalistycza
NOT_YET_RECRUITING
Warsaw
Mics Centrum Medyczne Warszawa Chlodna
NOT_YET_RECRUITING
Warsaw
Dermmedica Sp. Z O.O.
NOT_YET_RECRUITING
Wroclaw
Spain
Hospital General Unviersitario de Alicante
NOT_YET_RECRUITING
Alicante
Hospital de La Santa Creu I Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Sant Joan de Deu
NOT_YET_RECRUITING
Esplugues De Llobregat
Hospital Universitario Virgen de Las Nieves
NOT_YET_RECRUITING
Granada
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario de La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro de Majadahonda
NOT_YET_RECRUITING
Majadahonda
Hospital Regional Universitario de Malaga
NOT_YET_RECRUITING
Málaga
Hospital de Manises
NOT_YET_RECRUITING
Manises
Complejo Hospitalario Universitario de Santiago
NOT_YET_RECRUITING
Santiago De Compostela
United Kingdom
West Glasgow Ambulatory Care Hospital
NOT_YET_RECRUITING
Glasgow
St John'S Institute of Dermatology
NOT_YET_RECRUITING
London
The Adam Practice
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
University of Nottingham Health Service
NOT_YET_RECRUITING
Nottingham
Sheffield Childrens Hospital
NOT_YET_RECRUITING
Sheffield
Walsall Manor Hospital
NOT_YET_RECRUITING
Walsall
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2028-05-18
Participants
Target number of participants: 240
Treatments
Experimental: Vehicle-controlled (VC) Period: Ruxolitinib (1.5% Cream)
Study drug will be administered twice daily.
Placebo_comparator: VC Period: Vehicle Cream
Matching vehicle cream will be administered twice daily.
Experimental: Disease Control (DC) Period: Ruxolitinib (1.5% Cream)
Study drug will be administered twice weekly.
Placebo_comparator: DC Period: Vehicle Cream
Matching vehicle cream will be administered twice weekly.
Experimental: DC Period: Open Label - Ruxolitinib (1.5% Cream)
Study drug will be administered twice daily to treat Disease Exacerbations.
Experimental: Open-label Extension (OLE) period: Ruxolitinib (1.5% Cream)
Study drug will be administered twice daily.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov

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