Clinical trial NCT05259722: A 24 Week 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hand Eczema
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Main inclusion criteria:

* 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

Main exclusion criteria:

* Concurrent skin diseases on the hands, e.g. tinea manuum.
* Active atopic dermatitis requiring medical treatment in regions other than the hands and feet.
* Active psoriasis on any part of the body.
* Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
* Clinically significant infection on the hands.
* Participants who cannot receive alitretinoin.
* Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial.
* History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal 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 at screening.
* 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 prior to baseline.
* Previous or current treatment with Janus kinase (JAK) inhibitors (including delgocitinib/LEO 124249), systemic or topical.
* Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days 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 of subject's own emollients) within 7 days prior to baseline.
* Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.
* Treatment with any marketed biological therapy or investigational biologic agents:

  * Any cell-depleting agents: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
  * Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
* Previously used alitretinoin or participated in a clinical trial with alitretinoin or delgocitinib.

Primary outcomes:
measure: Change in HECSI Score From Baseline to Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: HECSI-90 at Week 12
timeFrame: 12 weeks
measure: IGA-CHE TS at Week 12.
timeFrame: 12 weeks
measure: Change in HESD Itch Score (Weekly Average) From Baseline to Week 12
timeFrame: 12 weeks
measure: Change in HESD Pain Score (Weekly Average) From Baseline to Week 12.
timeFrame: 12 weeks
measure: AUC of HECSI-90 From Baseline up to Week 24
timeFrame: 24 weeks
measure: AUC of Change From Baseline in DLQI Score up to Week 24
timeFrame: 24 weeks
measure: Change in HECSI Score From Baseline to Week 24
timeFrame: 24 weeks
measure: Number of Treatment-emergent AEs From Baseline up to Week 26
timeFrame: 26 weeks
measure: Number of Treatment-emergent SAEs From Baseline up to Week 26
timeFrame: 26 weeks
measure: Number of AEs Leading to IMP Discontinuation up to Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LEO Pharma Investigational Site
city: Linz
country: Austria
facility: LEO Pharma Investigational Site
city: Linz
country: Austria
facility: LEO Pharma Investigational Site
city: Calgary
country: Canada
facility: LEO Pharma Investigational Site
city: Calgary
country: Canada
facility: LEO Pharma Investigational Site
city: Edmonton
country: Canada
facility: LEO Pharma Investigational Site
city: Edmonton
country: Canada
facility: LEO Pharma Investigational Site
city: Guelph
country: Canada
facility: LEO Pharma Investigational Site
city: London
country: Canada
facility: LEO Pharma Investigational Site
city: London
country: Canada
facility: LEO Pharma investigational site
city: Markham
country: Canada
facility: LEO Pharma investigational site
city: Niagara Falls
country: Canada
facility: LEO Pharma investigational site
city: North York
country: Canada
facility: LEO Pharma Investigational Site
city: Québec
country: Canada
facility: LEO Pharma investigational site
city: Red Deer
country: Canada
facility: LEO Pharma Investigational Site
city: Sherbrooke
country: Canada
facility: LEO Pharma investigational site
city: Antony
country: France
facility: LEO Pharma Investigational Site
city: Martigues
country: France
facility: LEO Pharma Investigational Site
city: Montpellier
country: France
facility: LEO Pharma Investigational Site
city: Nice
country: France
facility: LEO Pharma Investigational Site
city: Nice
country: France
facility: LEO Pharma investigational site
city: Reims
country: France
facility: LEO Pharma Investigational Site
city: Toulon
country: France
facility: LEO Pharma Investigational Site
city: Augsburg
country: Germany
facility: LEO Pharma Investigational Site
city: Berlin
country: Germany
facility: LEO Pharma Investigational Site
city: Berlin
country: Germany
facility: LEO Pharma Investigational Site
city: Bochum
country: Germany
facility: LEO Pharma Investigational Site
city: Bochum
country: Germany
facility: LEO Pharma Investigational Site
city: Bonn
country: Germany
facility: LEO Pharma Investigational Site
city: Darmstadt
country: Germany
facility: LEO Pharma Investigational Site
city: Dresden
country: Germany
facility: LEO Pharma Investigational Site
city: Erlangen
country: Germany
facility: LEO Pharma Investigational Site
city: Essen
country: Germany
facility: LEO Pharma Investigational Site
city: Frankfurt
country: Germany
facility: LEO Pharma Investigational Site
city: Friedrichshafen
country: Germany
facility: LEO Pharma Investigational Site
city: Gera
country: Germany
facility: LEO Pharma Investigational Site
city: Göttingen
country: Germany
facility: LEO Pharma Investigational Site
city: Halle
country: Germany
facility: LEO Pharma Investigational Site
city: Hamburg
country: Germany
facility: LEO Pharma Investigational Site
city: Heidelberg
country: Germany
facility: LEO Pharma Investigational Site
city: Langenau
country: Germany
facility: LEO Pharma Investigational Site
city: Lohne
country: Germany
facility: LEO Pharma Investigational Site
city: Mainz
country: Germany
facility: LEO Pharma Investigational Site
city: Marburg
country: Germany
facility: LEO Pharma Investigational Site
city: Memmingen
country: Germany
facility: LEO Pharma Investigational Site
city: München
country: Germany
facility: LEO Pharma Investigational Site
city: München
country: Germany
facility: LEO Pharma Investigational Site
city: Oldenburg
country: Germany
facility: LEO Pharma Investigational Site
city: Osnabrück
country: Germany
facility: LEO Pharma Investigational Site
city: Wuppertal
country: Germany
facility: LEO Pharma Investigational Site
city: Bologna
country: Italy
facility: LEO Pharma Investigational Site
city: Brescia
country: Italy
facility: LEO Pharma Investigational Site
city: Catania
country: Italy
facility: LEO Pharma Investigational Site
city: Catanzaro
country: Italy
facility: LEO Pharma Investigational Site
city: Genova
country: Italy
facility: LEO Pharma Investigational Site
city: Lucca
country: Italy
facility: LEO Pharma Investigational Site
city: Milano
country: Italy
facility: LEO Pharma Investigational Site
city: Pavia
country: Italy
facility: LEO Pharma Investigational Site
city: Pisa
country: Italy
facility: LEO Pharma Investigational Site
city: Terracina
country: Italy
facility: LEO Pharma Investigational Site
city: Stavanger
country: Norway
facility: LEO Pharma Investigational Site
city: Tromsø
country: Norway
facility: LEO Pharma Investigational Site
city: Białystok
country: Poland
facility: LEO Pharma Investigational Site
city: Bydgoszcz
country: Poland
facility: LEO Pharma investigational site
city: Chorzów
country: Poland
facility: LEO Pharma Investigational Site
city: Gdańsk
country: Poland
facility: LEO Pharma Investigational Site
city: Gdynia
country: Poland
facility: LEO Pharma Investigational Site
city: Katowice
country: Poland
facility: LEO Pharma Investigational Site
city: Katowice
country: Poland
facility: LEO Pharma investigational site
city: Katowice
country: Poland
facility: LEO Pharma investigational site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Kraków
country: Poland
facility: LEO Pharma Investigational Site
city: Lublin
country: Poland
facility: LEO Pharma Investigational Site
city: Poznań
country: Poland
facility: LEO Pharma Investigational Site
city: Strzelce Opolskie
country: Poland
facility: LEO Pharma Investigational Site
city: Szczecin
country: Poland
facility: LEO Pharma Investigational Site
city: Warszawa
country: Poland
facility: LEO Pharma Investigational Site
city: Wrocław
country: Poland
facility: LEO Pharma Investigational Site
city: Łódź
country: Poland
facility: LEO Pharma Investigational Site
city: Bratislava
country: Slovakia
facility: LEO Pharma Investigational Site
city: Svidník
country: Slovakia
facility: LEO Pharma Investigational Site
city: Trnava
country: Slovakia
facility: LEO Pharma Investigational Site
city: Alcalá de Henares
country: Spain
facility: LEO Pharma Investigational Site
city: Alicante
country: Spain
facility: LEO Pharma Investigational Site
city: Badalona
country: Spain
facility: LEO Pharma Investigational Site
city: Barcelona
country: Spain
facility: LEO Pharma Investigational Site
city: Barcelona
country: Spain
facility: LEO Pharma Investigational Site
city: Córdoba
country: Spain
facility: LEO Pharma Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Madrid
country: Spain
facility: LEO Pharma Investigational Site
city: Málaga
country: Spain
facility: LEO Pharma investigational site
city: Pontevedra
country: Spain
facility: LEO Pharma investigational site
city: Sevilla
country: Spain
facility: LEO Pharma Investigational Site
city: Valencia
country: Spain
facility: LEO Pharma Investigational Site
city: Valencia
country: Spain
facility: LEO Pharma Investigational Site
city: Zaragoza
country: Spain
facility: LEO Pharma Investigational Site
city: London
country: United Kingdom
facility: LEO Pharma Investigational Site
city: Nottingham
country: United Kingdom
facility: LEO Pharma Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References:
citation: Gimenez-Arnau AM, Pinter A, Sondermann W, Reguiai Z, Woolf R, Lynde C, Legat FJ, Costanzo A, Silvestre JF, Mellerup N, Osterdal ML, Plohberger U, Ryttig L, Bauer A; trial investigators. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial. Lancet. 2025 May 10;405(10490):1676-1688. doi: 10.1016/S0140-6736(25)00001-7. Epub 2025 Apr 16.