NCT06004050|CompletedPhase 3

A Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Delgocitinib Cream in Chinese Adults and Adolescents With Moderate to Severe Chronic Hand Eczema

A Phase 3 Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Twice-Daily Applications of Delgocitinib Cream 20 mg/g in Chinese Adults and Adolescents (12-17 Years of Age) With Moderate to Severe Chronic Hand Eczema

LEO Pharma ClinicalTrials.gov

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1 other identifier

LP0133-2283

Study Type

interventional

Target

362

Locations

1 country

Sites

Timeline

RegisteredAug 2023

StartedSep 2023

CompletionSep 2025

Brief Summary

The primary objective of this study is to evaluate the efficacy of twice-daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of participants with moderate to severe chronic hand eczema (CHE).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

362

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Sep 2023

Geographic Reach

1 country

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

August 16, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed

14 days until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2024

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed

Last Updated

September 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

August 16, 2023

Last Update Submit

September 22, 2025

Conditions

Chronic Hand Eczema

Keywords

Dermatologic DiseaseDermatologyEczemaChronic Hand EczemaDelgocitinib

Outcome Measures

Primary Outcomes (1)

Investigator Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16
The IGA-CHE score ranges from 0 (clear) to 4 (severe). Treatment response is defined as a score of 0 or 1.
Week 16

Secondary Outcomes (18)

Hand Eczema Severity Index (HECSI)-90 at Week 16
Week 16
HECSI-75 at Week 16
Week 16
Percentage Change in HECSI Score From Baseline to Week 16
Baseline and Week 16
Number of Participants With Reduction of Hand Eczema Symptom Diary (HESD) Itch Score by ≥4 Points From Baseline at Week 16
Baseline and Week 16
Number of Participants With Reduction of HESD Score by ≥4 Points From Baseline at Week 16
Baseline and Week 16
+13 more secondary outcomes

Study Arms (3)

Double-Blind Period: Twice-Daily Delgocitinib Cream

EXPERIMENTAL

20 mg/g twice daily

Drug: Delgocitinib

Double-Blind Period: Twice-Daily Vehicle Cream

PLACEBO COMPARATOR

20 mg/g twice daily

Other: Vehicle cream

Open Label Period: Twice-Daily Delgocitinib

EXPERIMENTAL

20 mg/g twice daily

Drug: Delgocitinib

Interventions

DelgocitinibDRUG

Topical administration

Double-Blind Period: Twice-Daily Delgocitinib CreamOpen Label Period: Twice-Daily Delgocitinib

Vehicle creamOTHER

Topical administration

Double-Blind Period: Twice-Daily Vehicle Cream

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Age 18 years or above at screening for adult participants and age 12-17 years at screening and baseline for adolescent participants.
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).
HESD itch score (weekly average) of ≥4 points at baseline. The baseline weekly average will be calculated from daily assessments of itch severity during the 7 days immediately preceding the baseline visit (Day -7 to Day -1). A minimum of 4 itch scores out of the 7 days is required to calculate the baseline average score.
Participants 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 IGACHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent), 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.
Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
A woman of childbearing potential (WOCBP) must use an acceptable method of birth control throughout the trial up until the last application of investigational medicinal product (IMP).

You may not qualify if:

Active atopic dermatitis (AD) requiring medical treatment in regions other than the hands and feet.
Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
Clinically significant infection (e.g. impetiginized hand eczema) on the hands.
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 investigational medicinal product (IMP), or reduce the participant's ability to participate in the trial. Clinically significant infections are defined as:
A systemic infection.
A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
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.
History of cancer:
Participants who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the participant is in remission and curative therapy was completed at least 12 months prior to screening.
Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to screening.
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. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, immunological, and psychiatric disorders, and major physical impairment.
Any abnormal finding which may:
Put the participant at risk because of their participation in the trial.
+24 more criteria

Contact the study team to confirm eligibility.