Actively Recruiting
Phase 3b Study of Ruxolitinib Cream for Moderate Atopic Dermatitis in Children and Adolescents Aged 6 to Under 18 Years
Led by Incyte Corporation · Updated on 2025-12-18
240
Participants Needed
96
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ruxolitinib cream in children and adolescents aged 6 to under 18 years with moderate atopic dermatitis. This condition involves skin inflammation and itching, and the study aims to provide new treatment options by comparing ruxolitinib cream to a matching vehicle cream. The trial is a Phase 3b, randomized, double-blind study sponsored by Incyte Corporation. Participants will be assigned randomly to receive either ruxolitinib cream or a vehicle cream. The creams will be applied twice daily or twice weekly depending on the study period. The study includes a vehicle-controlled phase and a disease control phase, with an open-label extension period where all participants may receive ruxolitinib cream. The treatment regimen also allows twice-daily application during disease flare-ups. During the study, participants will regularly visit the clinic for assessments including skin evaluations using the Eczema Area and Severity Index (EASI), Investigator's Global Assessment, itch severity ratings, and quality of life questionnaires. Blood samples will be taken to measure drug levels and safety labs. The study will monitor adverse events and disease flare-ups for up to 70 weeks. Participants and their guardians will keep diaries to track symptoms and cream usage throughout the trial.
CONDITIONS
Brief Title
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 6 to under 18 years at the first visit
- Diagnosis of atopic dermatitis by Hanifin and Rajka criteria
- Duration of atopic dermatitis at least 3 months if aged 6-11, or at least 2 years if aged 12 to under 18
- Eczema Area and Severity Index (EASI) score greater than 7 at screening and first visit
- Investigator's Global Assessment (IGA) score of 3 at screening and first visit
- At least 3% and up to 20% body surface area affected (excluding scalp) at screening and first visit
- Itch Numeric Rating Scale or Worst Itch Numeric Rating Scale score of 4 or higher based on the 7 days before first visit
- History within 12 months of inadequate response, intolerance, or contraindication to topical corticosteroids or calcineurin inhibitors
- Agreement to stop all other treatments for atopic dermatitis during the study except bland emollients
- For sexually active participants, willingness to use contraception during study
- Ability and willingness to provide informed consent and assent as applicable
You will not qualify if you...
- Unstable or rapidly changing atopic dermatitis in the 4 weeks before first visit
- Immunocompromised conditions such as lymphoma or AIDS
- Recent infections requiring systemic treatment within 2 weeks before first visit
- Active skin infections within 1 week before first visit
- Other skin disorders or extensive scarring affecting evaluation
- Atopic dermatitis lesions only on hands or feet without classic area involvement
- Other types of eczema within 6 months before screening (except scalp seborrheic dermatitis)
- Current or past hepatitis B or C infection
- Serious medical or psychiatric conditions interfering with study participation
- Abnormal laboratory results posing risk according to investigator
- Use of certain treatments or immunosuppressants within specified washout periods before first visit
- History of treatment failure with systemic or topical JAK inhibitors
- Recent ultraviolet light therapy or planned exposure affecting condition
- Participation in other investigational drug studies within 30 days
- Pregnancy or lactation or planning pregnancy during study
- Living with someone in another Incyte ruxolitinib cream study
- Known allergy to study cream components
- Inability or unwillingness to comply with study procedures
- Commitment to mental health institution by legal order
- Employment or dependent status related to sponsor or investigators
- Vulnerable populations as defined by local regulations in France and EU restrictions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants apply the study cream topically as defined in the protocol, receiving either Ruxolitinib cream or matching vehicle cream.
Twice daily application with multiple visits during this period
Duration - Up to 44 weeks
Participants continue treatment with Ruxolitinib or vehicle cream during the Disease Control period, applying cream twice weekly or twice daily for exacerbations as defined, to manage atopic dermatitis.
Regular visits during the period with assessments
Duration - Up to 70 weeks
Participants receive open-label Ruxolitinib cream applied twice daily during the extension period.
Visits scheduled throughout the open-label extension period
Trial Site Locations
Total: 96 locations
1
Clinical Research Center of Alabama
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Saguaro Dermatology
Phoenix, Arizona, United States, 85008
Actively Recruiting
3
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
4
Encore Medical Research, Llc Hollywood
Hollywood, Florida, United States, 33024
Actively Recruiting
5
Lane Dermatology and Dermatologic Surgery
Columbus, Georgia, United States, 31904
Not Yet Recruiting
6
Cleaver Medical Group
Cumming, Georgia, United States, 30040
Actively Recruiting
7
Treasure Valley Medical Research
Boise, Idaho, United States, 83706
Actively Recruiting
8
Sneeze Wheeze and Itch Associates Llc
Normal, Illinois, United States, 61761
Actively Recruiting
9
Endeavor Health Medical Group
Skokie, Illinois, United States, 60077
Not Yet Recruiting
10
Raven Clinical Research
Marriottsville, Maryland, United States, 21104
Actively Recruiting
11
Oakland Hills Dermatology Pc
Auburn Hills, Michigan, United States, 48326
Not Yet Recruiting
12
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
13
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Not Yet Recruiting
14
Red River Research Partners
Bolivar, Missouri, United States, 65613
Actively Recruiting
15
Medisearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
16
University of Rochester Medical Center
Rochester, New York, United States, 14620
Not Yet Recruiting
17
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
18
University of Texas Physicians - Bellaire Station
Bellaire, Texas, United States, 77401
Not Yet Recruiting
19
Frontier Dermatology
Mill Creek, Washington, United States, 98012
Not Yet Recruiting
20
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
21
Cliniques Universitaires Ucl Saint-Luc
Brussels, Belgium, 01200
Not Yet Recruiting
22
Az Sint-Lucas
Ghent, Belgium, 09000
Not Yet Recruiting
23
Universitair Ziekenhuis Gent
Ghent, Belgium, 09000
Actively Recruiting
24
Grand Hôpital de Charleroi-Les Viviers
Gilly, Belgium, 06060
Actively Recruiting
25
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium, 04000
Actively Recruiting
26
Dermatologie Maldegem
Maldegem, Belgium, 09990
Actively Recruiting
27
Kirk Barber Research
Calgary, Alberta, Canada, T2G 1B1
Not Yet Recruiting
28
Dermatology Research Institute Inc.
Calgary, Alberta, Canada, T2J 7E1
Not Yet Recruiting
29
Laster Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta, Canada, T5J 3S9
Not Yet Recruiting
30
Dr. Chih-Ho Hong Medical Inc.
Surrey, British Columbia, Canada, V3R 6A7
Not Yet Recruiting
31
University of British Columbia (Ubc) - British Columbia Children'S Hospital (Bc Children'S Hospital)
Vancouver, British Columbia, Canada, V6H 3V4
Not Yet Recruiting
32
Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2
Actively Recruiting
33
Leader Research
Hamilton, Ontario, Canada, L8L 3C3
Actively Recruiting
34
Facet Dermatology
Toronto, Ontario, Canada, M4E 1R7
Actively Recruiting
35
K. Papp Clinical Research
Waterloo, Ontario, Canada, N2J 1C4
Withdrawn
36
Centre de Recherche Saint-Louis
Montreal, Quebec, Canada, H1Y3LI
Not Yet Recruiting
37
Chu Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Not Yet Recruiting
38
Chu de Quebec Universite Laval
Québec, Quebec, Canada, G1V 4G2
Not Yet Recruiting
39
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada, S7K 2C1
Actively Recruiting
40
Skincare Studio Dermatology Centre
St. John's, Canada, A1E 1V4
Not Yet Recruiting
41
Bordeaux Chu Hopital Saint - Andre
Bordeaux, France, 33000
Actively Recruiting
42
Polyclinique Reims-Bezannes
Reims, France, 51100
Not Yet Recruiting
43
Hopitaux Drome Nord
Romans-sur-Isère, France, 26102
Not Yet Recruiting
44
Fachklinik Bad Bentheim Dermatologie
Bad Bentheim, Germany, 48455
Actively Recruiting
45
Universitatsklinikum Bonn Aoer
Bonn, Germany, 53127
Actively Recruiting
46
Drk Krankenhaus Chemnitz-Rabenstein
Chemnitz, Germany, 09117
Not Yet Recruiting
47
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, Germany, 01307
Not Yet Recruiting
48
Universitatsklinikum Frankfurt
Frankfurt, Germany, 60590
Not Yet Recruiting
49
Universitatsmedizin Goettingen
Göttingen, Germany, 37075
Actively Recruiting
50
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
51
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, Germany, 55131
Not Yet Recruiting
52
Universitatsklinikum Munster
Münster, Germany, 48149
Actively Recruiting
53
Clinexpert Kft.
Budapest, Hungary, 01033
Actively Recruiting
54
Obudai Egeszsegugyi Centrum Kft.
Budapest, Hungary, 01036
Actively Recruiting
55
Geomedical Orvosi Kft.
Budapest, Hungary, 01066
Not Yet Recruiting
56
Semmelweis Egyetem
Budapest, Hungary, 01083
Not Yet Recruiting
57
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
Debrecen, Hungary, 04032
Not Yet Recruiting
58
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, Hungary, 06000
Not Yet Recruiting
59
Pecsi Tudomanyegyetem
Pécs, Hungary, 07632
Not Yet Recruiting
60
Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary, 06720
Not Yet Recruiting
61
Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
Catania, Italy, 95123
Not Yet Recruiting
62
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, Italy, 20122
Not Yet Recruiting
63
Azienda Ospedaliera Universitaria Federico Ii
Naples, Italy, 80131
Not Yet Recruiting
64
Azienda Ospedale Universita Di Padova
Padova, Italy, 35128
Not Yet Recruiting
65
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, Italy, 00168
Not Yet Recruiting
66
Umc Utrecht
Utrecht, Netherlands, 3584 CX
Withdrawn
67
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
Gdansk, Poland, 80-546
Actively Recruiting
68
Gyncentrum Sp. Z O.O.
Katowice, Poland, 40-600
Actively Recruiting
69
Grazyna Pulka Centrum Medyczne All Med Spolka Komandytowa
Krakow, Poland, 30-033
Actively Recruiting
70
Diamond Clinic Sp. Z O.O.
Krakow, Poland, 31-559
Actively Recruiting
71
Dermoklinika
Lodz, Poland, 90-436
Actively Recruiting
72
Clinical Best Solutions Sp. Z O.O. Sp. K.
Lublin, Poland, 20-011
Actively Recruiting
73
Dermodent Centrum Medyczne Czajkowscy S.C.
Osielsko, Poland, 86-031
Withdrawn
74
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland, 71- 500
Actively Recruiting
75
Mics Centrum Medyczne Toruń
Torun, Poland, 87-100
Actively Recruiting
76
Mics Centrum Medyczne Warszawa Chlodna
Warsaw, Poland, 00-872
Actively Recruiting
77
High-Med Przychodnia Specjalistycza
Warsaw, Poland, 01-817
Actively Recruiting
78
Centrum Medyczne Evimed
Warsaw, Poland, 02-625
Actively Recruiting
79
Etg Warszawa
Warsaw, Poland, 02-677
Actively Recruiting
80
Dermmedica Sp. Z O.O.
Wroclaw, Poland, 51-503
Actively Recruiting
81
Hospital General Unviersitario de Alicante
Alicante, Spain, 03010
Not Yet Recruiting
82
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Not Yet Recruiting
83
Hospital Sant Joan de Deu
Esplugues de Llobregat, Spain, 08950
Not Yet Recruiting
84
Hospital Universitario Virgen de Las Nieves
Granada, Spain, 18014
Not Yet Recruiting
85
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
86
Hospital Universitario de La Paz
Madrid, Spain, 28046
Not Yet Recruiting
87
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, Spain, 28222
Not Yet Recruiting
88
Hospital de Manis
Manises, Spain, 46940
Not Yet Recruiting
89
Hospital Regional Universitario de Malaga
Málaga, Spain, 29010
Not Yet Recruiting
90
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain, 15706
Not Yet Recruiting
91
West Glasgow Ambulatory Care Hospital
Glasgow, United Kingdom, G3 8SJ
Not Yet Recruiting
92
St John'S Institute of Dermatology
London, United Kingdom, SE1 7EH
Not Yet Recruiting
93
The Adam Practice
Metropolitan Borough of Wirral, United Kingdom, CH49 5PE
Not Yet Recruiting
94
University of Nottingham Health Service
Nottingham, United Kingdom, NG7 2QW
Not Yet Recruiting
95
Sheffield Childrens Hospital
Sheffield, United Kingdom, S10 2TH
Not Yet Recruiting
96
Walsall Manor Hospital
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
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here