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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05355818




Registration number
NCT05355818
Ethics application status
Date submitted
27/04/2022
Date registered
2/05/2022

Titles & IDs
Public title
Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
Scientific title
A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
Secondary ID [1] 0 0
2021-006340-27
Secondary ID [2] 0 0
LP0133-1426
Universal Trial Number (UTN)
Trial acronym
DELTA TEEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hand Eczema 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Delgocitinib
Treatment: Drugs - Cream vehicle

Experimental: Delgocitinib cream - Delgocitinib cream 20 mg/g twice daily

Placebo comparator: Cream vehicle - Cream vehicle twice daily


Treatment: Drugs: Delgocitinib
Cream for topical application

Treatment: Drugs: Cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IGA-CHE treatment success at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
HECSI-90 at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Reduction of HESD itch score (weekly average) of =4 points from baseline at Week 16
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Reduction of HESD pain score (weekly average) of =4 points from baseline at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Reduction of HESD score (weekly average) of =4 points from baseline at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
IGA-CHE treatment success at Week 2
Timepoint [5] 0 0
Week 2
Secondary outcome [6] 0 0
IGA-CHE treatment success at Week 4
Timepoint [6] 0 0
Week 4
Secondary outcome [7] 0 0
IGA-CHE treatment success at Week 8
Timepoint [7] 0 0
Week 8
Secondary outcome [8] 0 0
IGA-CHE treatment success at Week 12
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Change in cDLQI score from baseline to Week 16
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Number of treatment emergent AEs from baseline up to Week 18
Timepoint [10] 0 0
Week 18

Eligibility
Key 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 moderate to severe at screening and baseline according to IGA-CHE.
* Subjects who have a documented history of inadequate response to treatment with TCS or for whom TCS are documented to be otherwise medically inadvisable.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent skin disease on the hands.
* Clinically significant infection on the hands.
* Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).
* Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline.
* Previous or current treatment with 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 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.
* Any disorder which is not stable and could:

* Affect the safety of the subject throughout the trial.
* Impede the subject's ability to complete the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2024
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
LEO Pharma investigational site - Darlinghurst
Recruitment hospital [2] 0 0
LEO Pharma investigational site - Mitcham
Recruitment hospital [3] 0 0
LEO Pharma investigational site - Phillip
Recruitment hospital [4] 0 0
LEO Pharma investigational site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3132 - Mitcham
Recruitment postcode(s) [3] 0 0
2606 - Phillip
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Liège
Country [4] 0 0
Belgium
State/province [4] 0 0
Loverval
Country [5] 0 0
Canada
State/province [5] 0 0
Edmonton
Country [6] 0 0
Canada
State/province [6] 0 0
Fredericton
Country [7] 0 0
Canada
State/province [7] 0 0
Kingston
Country [8] 0 0
Canada
State/province [8] 0 0
Montreal
Country [9] 0 0
Canada
State/province [9] 0 0
Red Deer
Country [10] 0 0
Canada
State/province [10] 0 0
St. John's
Country [11] 0 0
Canada
State/province [11] 0 0
Toronto
Country [12] 0 0
Canada
State/province [12] 0 0
Winnipeg
Country [13] 0 0
France
State/province [13] 0 0
Bouches-du-Rhône
Country [14] 0 0
France
State/province [14] 0 0
Nice
Country [15] 0 0
France
State/province [15] 0 0
Reims
Country [16] 0 0
France
State/province [16] 0 0
Rouen
Country [17] 0 0
France
State/province [17] 0 0
Toulouse Cedex 9
Country [18] 0 0
Poland
State/province [18] 0 0
Chorzow
Country [19] 0 0
Poland
State/province [19] 0 0
Kraków
Country [20] 0 0
Poland
State/province [20] 0 0
Warszawa
Country [21] 0 0
Poland
State/province [21] 0 0
Wroclaw
Country [22] 0 0
Spain
State/province [22] 0 0
Alicante
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Cadiz
Country [25] 0 0
Spain
State/province [25] 0 0
Esplugues de Llobregat
Country [26] 0 0
Spain
State/province [26] 0 0
Fuenlabrada
Country [27] 0 0
Spain
State/province [27] 0 0
Granada
Country [28] 0 0
Spain
State/province [28] 0 0
Pontevedra
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Ipswich
Country [30] 0 0
United Kingdom
State/province [30] 0 0
King's Lynn
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Leytonstone
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Lincoln
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Walsall

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
LEO Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Expert
Address 0 0
LEO Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Disclosure
Address 0 0
Country 0 0
Phone 0 0
(+1) 877-557-1168
Fax 0 0
Email 0 0
disclosure@leo-pharma.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?


Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://leopharmatrials.com/for-researchers


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05355818