Efficacy and Safety of Delgocitinib Cream in Adolescents... | NCT05355818

ID	Type	Description	Link
2021-006340-27	EudraCT Number
U1111-1284-2122	Other Identifier	World Health Organization (WHO)

Label	Type	Description	Intervention Names
Delgocitinib cream	Experimental	Delgocitinib cream 20 mg/g twice daily	Drug: Delgocitinib
Cream vehicle	Placebo Comparator	Cream vehicle twice daily	Drug: Cream vehicle

Name	Type	Description	Arm Group Labels	Other Names
Delgocitinib	Drug	Cream for topical application	Delgocitinib cream

Measure	Description	Time Frame
Number of Participants With IGA-CHE Treatment Success at Week 16	The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.	Week 16

Measure	Description	Time Frame
Number of Participants With HECSI-90 at Week 16	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 12 to 17 years at screening and baseline.
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 (i.e. an IGA-CHE score of 3 or 4).
Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
- Inadequate response is defined as a history of failure to achieve and maintain a low disease activity state (comparable to an IGA-CHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent) for Europe and Australia and class IV-I (medium potency to very/ultra-high potency) for Canada, applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter.
- Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, and significant skin atrophy as assessed by the physician.

Exclusion Criteria:

Concurrent skin diseases on the hands, e.g. tinea manuum.
Clinically significant infection (e.g. impetiginised hand eczema) on the hands.
Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), 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 (e.g. ultraviolet B (UVB), ultraviolet A1 (UVA1), psoralen ultraviolet A (PUVA)), 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 (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus) 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. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, and major physical impairment.

Name	Affiliation	Role
Medical Expert	LEO Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
LEO Pharma investigational site		Darlinghurst		2010	Australia
LEO Pharma investigational site

PubMed Identifier	Type	Citation	Retractions
42235562	Derived	Molin S, Baselga E, Navarro-Trivino FJ, Reguiai Z, Schepper S, Halpern J, Marcoux D, Su JC, Brzewski P, Antonsen SD, Hiort LC, Sohoel A, Thogersen P, Rubel D. Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial. Lancet Child Adolesc Health. 2026 Jun 3:S2352-4642(26)00098-2. doi: 10.1016/S2352-4642(26)00098-2. Online ahead of print.

ID	Title	Description
FG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
FG001	Cream Vehicle

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 11, 2023	Apr 10, 2026

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG00074
- ParticipantsBG00124
- ParticipantsBG00298

Title	Measurements
<=18 years

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00074 ParticipantsBG00124 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00074 ParticipantsBG00124 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00074 ParticipantsBG00124 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00074 ParticipantsBG00124 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
Canada	ParticipantsBG00074 ParticipantsBG00124 ParticipantsBG002

IGA-CHE score

The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00074 ParticipantsBG00124 ParticipantsBG002

HECSI score

The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity.

Mean

Standard Deviation

scores on a scale

Title	Denominators	Categories
	ParticipantsBG00074 ParticipantsBG001

HESD itch score (weekly average)

The Hand Eczema Symptom Diary (HESD) itch score is one component of the HESD eDiary. In the HESD eDiary, participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis.

Data is missing for 1 participant in the delgocitinib cream group.

Mean

Standard Deviation

scores on a scale

Title	Denominators	Categories
	ParticipantsBG00073 ParticipantsBG001

HESD pain score (weekly average)

The Hand Eczema Symptom Diary (HESD) pain score is one component of the HESD eDiary. In the HESD eDiary, participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis.

Data is missing for 1 participant in the delgocitinib cream group.

Mean

Standard Deviation

scores on a scale

Title	Denominators	Categories
	ParticipantsBG00073 ParticipantsBG001

HESD score (weekly average)

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms.

Data is missing for 1 participant in the delgocitinib cream group.

Mean

Standard Deviation

scores on a scale

Title	Denominators	Categories
	ParticipantsBG00073 ParticipantsBG001

CDLQI score

The Children's Dermatology Life Quality Index (CDLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI score is the sum of the 10 items (score ranging from 0 to 30).

Mean

Standard Deviation

scores on a scale

Title	Denominators	Categories
	ParticipantsBG00074 ParticipantsBG00124 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With IGA-CHE Treatment Success at Week 16

The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Units	Counts
Participants	OG00074 OG00124

Title

Denominators

Categories

Title	Measurements
	OG00047 OG0017

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Based on the primary estimand 'composite'. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.	Bayesian	Historical information from LP0133-1401 (NCT04871711)/LP0133-1402 (NCT04872101) as prior information is used.		There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is > 0 is used.	Diff. in proportion of responders in %	37.9			2-Sided						There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 13.5% to 58.2%.

Secondary

Number of Participants With HECSI-90 at Week 16

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Secondary

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16

The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points.

Data is not available for 20 participants in the Delgocitinib cream group and for 5 participants in the cream vehicle group.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Secondary

Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16

The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points.

Data is not available for 25 participants in the Delgocitinib cream group and for 9 participants in the cream vehicle group.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Secondary

Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16

The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' The final HESD score is an average of these 6 individual scores. This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of ≥4 points.

Data is not available for 20 participants in the Delgocitinib cream group and for 8 participants in the cream vehicle group.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Secondary

Number of Participants With IGA-CHE Treatment Success at Week 2

Posted

Count of Participants

Participants

Week 2

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Units	Counts
Participants

Secondary

Number of Participants With IGA-CHE Treatment Success at Week 4

The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.

Posted

Count of Participants

Participants

Week 4

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Units	Counts
Participants

Secondary

Number of Participants With IGA-CHE Treatment Success at Week 8

Posted

Count of Participants

Participants

Week 8

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Units	Counts
Participants

Secondary

Number of Participants With IGA-CHE Treatment Success at Week 12

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Units	Counts
Participants

Secondary

Change in CDLQI Score From Baseline to Week 16

Posted

Least Squares Mean

Standard Error

score on a scale

Week 16

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Units	Counts

Secondary

Number of Treatment Emergent AEs From Baseline up to Week 18

An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment.

Posted

Number

events

Week 18

ID	Title	Description
OG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
OG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Units	Counts
Participants	OG000

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG00012 events10 affected74 at risk EG0014 events4 affected24 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0005 events5 affected74 at risk EG0010 events0 affected24 at risk
Headache	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected74 at risk EG0011 events1 affected24 at risk

ID	Title	Description
BG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.
BG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Delgocitinib Cream	Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application.	0	74	0	74	17	74
EG001	Cream Vehicle	Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.	0	24	0	24	4	24