Phase
Condition
Allergies & Asthma
Allergy
Atopic Dermatitis
Treatment
Delgocitinib
Toctino
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Main inclusion criteria:
Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 monthsor returned twice or more within the last 12 months.
Disease severity graded as severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 4).
Participants who have a documented recent history of inadequate response totreatment with topical corticosteroids (TCS) or for whom TCS are documented to beotherwise medically inadvisable (e.g. due to important side effects or safetyrisks).
Participants adherent to standard non-medicated skin care including avoidance ofknown and relevant irritants and allergens.
Participants must use contraceptive methods in accordance with local regulationsregarding the methods of contraception for those participating in clinical studies
Exclusion
Main exclusion criteria:
Concurrent skin diseases on the hands, e.g. tinea manuum.
Active atopic dermatitis requiring medical treatment in regions other than the handsand feet.
Active psoriasis on any part of the body.
Hyperkeratotic hand eczema in combination with a history of psoriasis on any part ofthe body.
Clinically significant infection on the hands.
Participants who cannot receive alitretinoin.
Clinically significant infection within 28 days prior to baseline which, in theopinion of the investigator, may compromise the safety of the participant in thetrial, interfere with evaluation of the IMP, or reduce the participant's ability toparticipate in the trial.
History of any known primary immunodeficiency disorder including a positive humanimmunodeficiency virus (HIV) test at screening, or the participant takingantiretroviral medications as determined by medical history and/or participant'sverbal report.
Any disorder which is not stable and could:
Affect the safety of the participant throughout the trial.
Impede the participant's ability to complete the trial.
Positive hepatitis B surface antigen or hepatitis C virus antibody serology atscreening.
Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids,or corticosteroids within 28 days prior to baseline.
Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days priorto baseline.
Previous or current treatment with Janus kinase (JAK) inhibitors (includingdelgocitinib/LEO 124249), systemic or topical.
Cutaneously applied treatment with immunomodulators or TCS on the hands within 14days prior to baseline.
Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.
Other transdermal or cutaneously applied therapy on the hands (except for the use ofsubject's own emollients) within 7 days prior to baseline.
Cutaneously applied treatments in regions other than the hands, which couldinterfere with clinical trial evaluations or pose a safety concern within 7 daysprior to baseline.
Treatment with any marketed biological therapy or investigational biologic agents:
Any cell-depleting agents: within 6 months prior to baseline, or untillymphocyte count returns to normal, whichever is longer.
Other biologics: within 3 months or 5 half-lives, whichever is longer, prior tobaseline.
Previously used alitretinoin or participated in a clinical trial with alitretinoinor delgocitinib.
Study Design
Connect with a study center
LEO Pharma Investigational Site
Graz, 8036
AustriaSite Not Available
LEO Pharma Investigational Site
Linz, 4021
AustriaSite Not Available
LEO Pharma investigational site
Wien, 1200
AustriaSite Not Available
LEO Pharma Investigational Site
Calgary, T2W 4X9
CanadaSite Not Available
LEO Pharma Investigational Site
Edmonton, T6G 1C3
CanadaSite Not Available
LEO Pharma Investigational Site
Guelph, N1L 0B7
CanadaSite Not Available
LEO Pharma Investigational Site
London, N6A 2C2
CanadaSite Not Available
LEO Pharma investigational site
London, N6A 5R9
CanadaSite Not Available
LEO Pharma investigational site
Markham, L3P 1X3
CanadaSite Not Available
LEO Pharma investigational site
Niagara Falls, L2H 1H5
CanadaSite Not Available
LEO Pharma Investigational Site
North York, M2N 3A6
CanadaSite Not Available
LEO Pharma investigational site
Québec, G1W 4R4
CanadaSite Not Available
LEO Pharma Investigational Site
Red Deer, T4P 1K4
CanadaSite Not Available
LEO Pharma investigational site
Sherbrooke, J1G 1X9
CanadaSite Not Available
LEO Pharma investigational site
Toronto, M9W 4L6
CanadaSite Not Available
LEO Pharma investigational site
Vancouver, V5Z 4E8
CanadaSite Not Available
LEO Pharma Investigational Site
Antony, 92160
FranceSite Not Available
LEO Pharma Investigational Site
Martigues, 13500
FranceSite Not Available
LEO Pharma Investigational Site
Montpellier, 34295
FranceSite Not Available
LEO Pharma Investigational Site
Nice, 06000
FranceSite Not Available
LEO Pharma investigational site
Nice, 6202
FranceSite Not Available
LEO Pharma Investigational Site
Pierre-Bénite, 69495
FranceSite Not Available
LEO Pharma Investigational Site
Reims, 51100
FranceSite Not Available
LEO Pharma Investigational Site
Rennes Cedex 9, 35033
FranceSite Not Available
LEO Pharma Investigational Site
Toulon, 83000
FranceSite Not Available
LEO Pharma Investigational Site
Augsburg, 86163
GermanySite Not Available
LEO Pharma Investigational Site
Berlin, 10789
GermanySite Not Available
LEO Pharma Investigational Site
Bochum, 44793
GermanySite Not Available
LEO Pharma Investigational Site
Bonn, 53111
GermanySite Not Available
LEO Pharma Investigational Site
Darmstadt, 64283
GermanySite Not Available
LEO Pharma Investigational Site
Dresden, 01307
GermanySite Not Available
LEO Pharma Investigational Site
Erlangen, 91054
GermanySite Not Available
LEO Pharma Investigational Site
Essen, 45147
GermanySite Not Available
LEO Pharma Investigational Site
Frankfurt, 60590
GermanySite Not Available
LEO Pharma Investigational Site
Friedrichshafen, 88045
GermanySite Not Available
LEO Pharma Investigational Site
Gera, 07548
GermanySite Not Available
LEO Pharma Investigational Site
Göttingen, 37075
GermanySite Not Available
LEO Pharma Investigational Site
Halle, 06110
GermanySite Not Available
LEO Pharma Investigational Site
Hamburg, 22391
GermanySite Not Available
LEO Pharma Investigational Site
Heidelberg, 69120
GermanySite Not Available
LEO Pharma Investigational Site
Ibbenbüren, 49477
GermanySite Not Available
LEO Pharma Investigational Site
Kiel, 24105
GermanySite Not Available
LEO Pharma Investigational Site
Langenau, 89129
GermanySite Not Available
LEO Pharma Investigational Site
Lohne, 49393
GermanySite Not Available
LEO Pharma Investigational Site
Lohne, 49393
GermanySite Not Available
LEO Pharma Investigational Site
Mainz, 55131
GermanySite Not Available
LEO Pharma Investigational Site
Marburg, 35043
GermanySite Not Available
LEO Pharma Investigational Site
Memmingen, 87700
GermanySite Not Available
LEO Pharma Investigational Site
München, 80337
GermanySite Not Available
LEO Pharma Investigational Site
Oldenburg, 26133
GermanySite Not Available
LEO Pharma Investigational Site
Osnabrück, 49074
GermanySite Not Available
LEO Pharma Investigational Site
Wuppertal, 42287
GermanySite Not Available
LEO Pharma Investigational Site
Bologna, 40138
ItalySite Not Available
LEO Pharma Investigational Site
Brescia, 25123
ItalySite Not Available
LEO Pharma Investigational Site
Catania, 95123
ItalySite Not Available
LEO Pharma Investigational Site
Catanzaro, 88100
ItalySite Not Available
LEO Pharma Investigational Site
Genova, 16132
ItalySite Not Available
LEO Pharma Investigational Site
Lucca, 55100
ItalySite Not Available
LEO Pharma Investigational Site
Milano, 20089
ItalySite Not Available
LEO Pharma Investigational Site
Napoli, 80131
ItalySite Not Available
LEO Pharma Investigational Site
Pavia, 27100
ItalySite Not Available
LEO Pharma Investigational Site
Pisa, 56126
ItalySite Not Available
LEO Pharma Investigational Site
Terracina, 4019
ItalySite Not Available
LEO Pharma Investigational Site
Bodø, 8005
NorwaySite Not Available
LEO Pharma Investigational Site
Stavanger, 4011
NorwaySite Not Available
LEO Pharma Investigational Site
Tromsø, 9038
NorwaySite Not Available
LEO Pharma Investigational Site
Białystok, 15-794
PolandSite Not Available
LEO Pharma investigational site
Bydgoszcz, 85-796
PolandSite Not Available
LEO Pharma Investigational Site
Chorzów, 41-500
PolandSite Not Available
LEO Pharma Investigational Site
Gdańsk, 80-546
PolandSite Not Available
LEO Pharma Investigational Site
Gdynia, 81-338
PolandSite Not Available
LEO Pharma Investigational Site
Katowice, 40-081
PolandSite Not Available
LEO Pharma investigational site
Katowice, 40-611
PolandSite Not Available
LEO Pharma Investigational Site
Kraków, 30-727
PolandSite Not Available
LEO Pharma Investigational Site
Lublin, 20-080
PolandSite Not Available
LEO Pharma Investigational Site
Poznań, 61-731
PolandSite Not Available
LEO Pharma Investigational Site
Skarżysko-Kamienna, 26-110
PolandSite Not Available
LEO Pharma Investigational Site
Strzelce Opolskie, 47-100
PolandSite Not Available
LEO Pharma Investigational Site
Szczecin, 71-434
PolandSite Not Available
LEO Pharma Investigational Site
Warszawa, 02-677
PolandSite Not Available
LEO Pharma investigational site
Warszawa, 01-817
PolandActive - Recruiting
LEO Pharma Investigational Site
Wrocław, 51-685
PolandSite Not Available
LEO Pharma Investigational Site
Łódź, 90-436
PolandSite Not Available
LEO Pharma Investigational Site
Bratislava, 851 01
SlovakiaSite Not Available
LEO Pharma Investigational Site
Svidník, 089 01
SlovakiaSite Not Available
LEO Pharma Investigational Site
Tmava, 91775
SlovakiaSite Not Available
LEO Pharma Investigational Site
Trnava, 917 75
SlovakiaSite Not Available
LEO Pharma Investigational Site
Alcalá de Henares, 28805
SpainSite Not Available
LEO Pharma Investigational Site
Alicante, 03010
SpainSite Not Available
LEO Pharma Investigational Site
Badalona, 08916
SpainSite Not Available
LEO Pharma Investigational Site
Barcelona, 08003
SpainSite Not Available
LEO Pharma Investigational Site
Córdoba, 14004
SpainSite Not Available
LEO Pharma Investigational Site
Hospitalet de Llobregat, 08907
SpainSite Not Available
LEO Pharma Investigational Site
Madrid, 28040
SpainSite Not Available
LEO Pharma investigational site
Málaga, 29009
SpainSite Not Available
LEO Pharma investigational site
Pontevedra, 36071
SpainSite Not Available
LEO Pharma Investigational Site
Sevilla, 41009
SpainSite Not Available
LEO Pharma Investigational Site
Valencia, 46014
SpainSite Not Available
LEO Pharma Investigational Site
Zaragoza, 50009
SpainSite Not Available
LEO Pharma Investigational Site
Bristol, BS2 8HW
United KingdomSite Not Available
LEO Pharma Investigational Site
London, SE1 9RT
United KingdomSite Not Available
LEO Pharma Investigational Site
Nottingham, NG7 2UH
United KingdomSite Not Available
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