Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema

A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics of Twice-daily Applications of Delgocitinib Cream 20 mg/g for 1 Week in Adult Subjects With Moderate to Severe Chronic Hand Eczema.

The purpose of the trial is to test how much delgocitinib enters the body over a given time period after application of delgocitinib cream in patients with moderate to severe hand eczema.

Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation. Everyone in the trial will use delgocitinib cream.

The trial will last up to 7 weeks and there will be 6 visits and a phone call. There will be a screening period of up to 4 weeks, a treatment period (with blood sampling) of 11 days and a safety follow-up phone call 11 days after the last visit.

Study Overview

• Status: Completed
• Conditions: Chronic Hand Eczema
• Intervention / Treatment: Drug: Delgocitinib

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20095
    • Leo Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or above at screening.
• 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).
• Subjects adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.

Exclusion Criteria:

• Concurrent skin diseases on the hands, e.g. tinea manuum.
• Active atopic dermatitis (AD) 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 (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.
• Cutaneously applied treatment with immunomodulators (e.g. phosphodiesterase 4 [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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delgocitinib cream 20 mg/g; Twice-daily topical application for 8 days	Drug: Delgocitinib; Cream for topical application 20 mg/g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve 0-12 hours post dose at Day 1 and Day 8 (AUC0-12).	0-12 hours post dose at Day 1 and Day 8
Maximum observed concentration (Cmax) at Day 1 and at Day 8 (0-12 hours post-dose).	Day 1 and at Day 8 (0-12 hours post-dose)

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to reach maximum observed concentration (tmax) at Day 1 and Day 8 (0-12 hours post-dose).	Day 1 and Day 8 (0-12 hours post-dose).
Terminal elimination half-life (t1/2) at Day 8.	Day 8.
Number of treatment-emergent adverse events (AEs) from baseline to Day 22 per subject.	Baseline to Day 22

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: LP0133-2285; 2022-000782-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No