Clinical trial NCT03683719: Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema
Official title: A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hand Eczema
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 258
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: The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.


Eligibility criteria: Key Inclusion Criteria:

* Age 18 years or above.
* Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
* Disease severity graded as mild to severe according to IGA (i.e., IGA ≥2).
* Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid treatment or topical corticosteroid treatment being medically inadvisable.
* Diagnostic patch testing performed within 3 years prior to the screening visit.

Key Exclusion Criteria:

* Concurrent skin diseases on the hands e.g tinnea manuum.
* Active atopic dermatitis in regions other than the hands or psoriasis requiring medical treatment.
* Clinically significant infection (e.g., impetiginised hand eczema) on the hands.
* Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
* Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks prior to baseline.
* Receipt of live attenuated vaccines 4 weeks prior to baseline.
* Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 (PDE-4) inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks prior to baseline.
* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to baseline.
* Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
* Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 1 week 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 1 week prior to baseline.
* Receipt of any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline or until cells count returns to normal, whichever is longer.
* Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
* Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening.
* History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications.
* Any disorder which is not stable and in the investigator's opinion could affect the safety of the subject, influence the findings of the trial, or impede the subject's ability to complete the trial.
* Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.

Primary outcomes:
measure: Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16.
timeFrame: Week 0 to Week 16.
Secondary outcomes:
measure: Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16.
timeFrame: Week 0 to Week 16.
measure: Time to IGA-CHE Treatment Success.
timeFrame: Week 0 to Week 16.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Leo Pharma Investigational Site
state: Arizona
city: Hialeah
country: United States
facility: Leo Pharma Investigational Site
state: Florida
city: Portland
country: United States
facility: Leo Pharma Investigational Site
state: Oregon
city: Portland
country: United States
facility: Leo Pharma Investigational Site
state: Oregon
city: Aarhus
country: Denmark
facility: Leo Pharma Investigational Site
city: Copenhagen
country: Denmark
facility: Leo Pharma Investigational Site
city: Hellerup
country: Denmark
facility: Leo Pharma Investigational Site
city: Herlev
country: Denmark
facility: LEO Pharma Investigational Site
city: Berlin
country: Germany
facility: Leo Pharma Investigational Site
city: Bochum
country: Germany
facility: Leo Pharma Investigational Site
city: Bremerhaven
country: Germany
facility: Leo Pharma Investigational Site
city: Dresden
country: Germany
facility: Leo Pharma Investigational Site
city: Düsseldorf
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: Jena
country: Germany
facility: Leo Pharma Investigational Site
city: Kiel
country: Germany
facility: Leo Pharma Investigational Site
city: Kiel
country: Germany
facility: Leo Pharma Investigational Site
city: Langenau
country: Germany
facility: Leo Pharma Investigational Site
city: Lübeck
country: Germany
facility: Leo Pharma Investigational Site
city: Mahlow
country: Germany
facility: Leo Pharma Investigational Site
city: Mainz
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: Selters
country: Germany
facility: Leo Pharma Investigational Site
city: Stuttgart
country: Germany
facility: Leo Pharma Investigational Site
city: Stuttgart
country: Germany
facility: Leo Pharma Investigational Site
city: Wuppertal
country: Germany
facility: Leo Pharma Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: