A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

Who is this study for? Adults with severe chronic hand eczema
What treatments are being studied? Delgocitinib
Status: Completed
Location: See all (102) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or 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 to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).

• Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.

• Participants must use contraceptive methods in accordance with local regulations regarding the methods of contraception for those participating in clinical studies

Locations
Other Locations
Austria
LEO Pharma Investigational Site
Graz
LEO Pharma Investigational Site
Linz
LEO Pharma Investigational Site
Linz
Canada
LEO Pharma Investigational Site
Calgary
LEO Pharma Investigational Site
Calgary
LEO Pharma Investigational Site
Edmonton
LEO Pharma Investigational Site
Edmonton
LEO Pharma Investigational Site
Guelph
LEO Pharma investigational site
London
LEO Pharma Investigational Site
London
LEO Pharma investigational site
Markham
LEO Pharma investigational site
Niagara Falls
LEO Pharma Investigational Site
North York
LEO Pharma investigational site
Québec
LEO Pharma Investigational Site
Red Deer
LEO Pharma investigational site
Sherbrooke
France
LEO Pharma Investigational Site
Antony
LEO Pharma Investigational Site
Martigues
LEO Pharma Investigational Site
Montpellier
LEO Pharma investigational site
Nice
LEO Pharma Investigational Site
Nice
LEO Pharma Investigational Site
Reims
LEO Pharma Investigational Site
Toulon
Germany
LEO Pharma Investigational Site
Augsburg
LEO Pharma Investigational Site
Berlin
LEO Pharma Investigational Site
Berlin
LEO Pharma Investigational Site
Bochum
LEO Pharma Investigational Site
Bochum
LEO Pharma Investigational Site
Bonn
LEO Pharma Investigational Site
Darmstadt
LEO Pharma Investigational Site
Dresden
LEO Pharma Investigational Site
Erlangen
LEO Pharma Investigational Site
Essen
LEO Pharma Investigational Site
Frankfurt
LEO Pharma Investigational Site
Friedrichshafen
LEO Pharma Investigational Site
Gera
LEO Pharma Investigational Site
Göttingen
LEO Pharma Investigational Site
Halle
LEO Pharma Investigational Site
Hamburg
LEO Pharma Investigational Site
Heidelberg
LEO Pharma Investigational Site
Langenau
LEO Pharma Investigational Site
Löhne
LEO Pharma Investigational Site
Mainz
LEO Pharma Investigational Site
Marburg
LEO Pharma Investigational Site
Memmingen
LEO Pharma Investigational Site
München
LEO Pharma Investigational Site
München
LEO Pharma Investigational Site
Oldenburg
LEO Pharma Investigational Site
Osnabrück
LEO Pharma Investigational Site
Wuppertal
Italy
LEO Pharma Investigational Site
Bologna
LEO Pharma Investigational Site
Brescia
LEO Pharma Investigational Site
Catania
LEO Pharma Investigational Site
Catanzaro
LEO Pharma Investigational Site
Genova
LEO Pharma Investigational Site
Lucca
LEO Pharma Investigational Site
Milan
LEO Pharma Investigational Site
Pavia
LEO Pharma Investigational Site
Pisa
LEO Pharma Investigational Site
Terracina
Norway
LEO Pharma Investigational Site
Stavanger
LEO Pharma Investigational Site
Tromsø
Poland
LEO Pharma Investigational Site
Bialystok
LEO Pharma investigational site
Bydgoszcz
LEO Pharma Investigational Site
Chorzów
LEO Pharma Investigational Site
Gdansk
LEO Pharma Investigational Site
Gdynia
LEO Pharma investigational site
Katowice
LEO Pharma investigational site
Katowice
LEO Pharma Investigational Site
Katowice
LEO Pharma Investigational Site
Krakow
LEO Pharma Investigational Site
Krakow
LEO Pharma Investigational Site
Krakow
LEO Pharma Investigational Site
Lodz
LEO Pharma Investigational Site
Lublin
LEO Pharma Investigational Site
Poznan
LEO Pharma Investigational Site
Strzelce Opolskie
LEO Pharma Investigational Site
Szczecin
LEO Pharma Investigational Site
Warsaw
LEO Pharma Investigational Site
Wroclaw
Slovakia
LEO Pharma Investigational Site
Bratislava
LEO Pharma Investigational Site
Svidník
LEO Pharma Investigational Site
Trnava
Spain
LEO Pharma Investigational Site
Alcalá De Henares
LEO Pharma Investigational Site
Alicante
LEO Pharma Investigational Site
Badalona
LEO Pharma Investigational Site
Barcelona
LEO Pharma Investigational Site
Barcelona
LEO Pharma Investigational Site
Córdoba
LEO Pharma Investigational Site
L'hospitalet De Llobregat
LEO Pharma Investigational Site
Madrid
LEO Pharma Investigational Site
Madrid
LEO Pharma Investigational Site
Madrid
LEO Pharma Investigational Site
Madrid
LEO Pharma investigational site
Málaga
LEO Pharma investigational site
Pontevedra
LEO Pharma Investigational Site
Seville
LEO Pharma Investigational Site
Valencia
LEO Pharma Investigational Site
Valencia
LEO Pharma Investigational Site
Zaragoza
United Kingdom
LEO Pharma Investigational Site
London
LEO Pharma Investigational Site
Nottingham
Time Frame
Start Date: 2022-06-15
Completion Date: 2023-12-05
Participants
Target number of participants: 513
Treatments
Experimental: Delgocitinib cream 20 mg/g
Twice-daily topical application for up to 24 weeks
Active_comparator: Alitretinoin capsules 30 mg per capsule
1 capsule per day for up to 24 weeks
Related Therapeutic Areas
Sponsors
Leads: LEO Pharma

This content was sourced from clinicaltrials.gov

Similar Clinical Trials