Clinical trial NCT03826901: Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children
Official title: A Phase 1 Open-label, Multi-centre, Single-arm Trial to Evaluate the Safety and Pharmacokinetics (Including MUsT) of Twice Daily Topical Application of Delgocitinib Cream for 8 Weeks in Adults, Adolescents, and Children With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: adults, pediatric
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 46
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.

Detailed description: A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis

Eligibility criteria: Key Inclusion criteria (Part 1: adults and adolescents; 12 years and above)

* Diagnosis of atopic dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria for AD
* Age 12 years and above at baseline
* AD involvement of 25-50% treatable body surface area (BSA) at screening and at baseline
* Moderate to severe AD (Validated Investigator Global Assessment scale for Atopic Dermatitis \[vIGA-AD\] score of at least 3) at screening and at baseline

Key Inclusion criteria (Part 2: children; 2-11 years)

* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
* Age 2-11 years at baseline
* History of AD for at least 3 months (children aged 2-5 years), and at least 12 months (children aged 6-11 years)
* AD involvement of ≥35% treatable BSA at screening and at baseline
* Moderate to severe AD (vIGA-AD score of at least 3) at screening and at baseline

Key Exclusion criteria (Part 1 and 2: subjects aged 2 years and above)

* Active dermatologic conditions that may interfere with the diagnosis of AD
* Use of tanning beds or phototherapy within 4 weeks prior to baseline
* Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline
* Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), topical phosphodiesterase-4, or oral antibiotics within 1 week prior to baseline
* Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline
* Any disorder, which is not stable, and in the investigator's opinion could affect the safety of the subject, influence the results of the trial or impede the subject's ability to complete the trial

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Week 0 to Week 8
Secondary outcomes:
measure: PK parameter - Cmax
timeFrame: at Day 8
measure: PK parameter - AUC
timeFrame: at Day 8
measure: PK parameter - tmax
timeFrame: at Day 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: LEO Pharma investigational site
state: Alabama
city: Phoenix
country: United States
facility: LEO Pharma investigational site
state: Arizona
city: Fountain Valley
country: United States
facility: LEO Pharma investigational site
state: California
city: Irvine
country: United States
facility: LEO Pharma investigational site
state: California
city: Los Angeles
country: United States
facility: LEO Pharma investigational site
state: California
city: Centennial
country: United States
facility: LEO Pharma investigational site
state: Colorado
city: New Haven
country: United States
facility: LEO Pharma investigational site
state: Connecticut
city: Indianapolis
country: United States
facility: LEO Pharma investigational site
state: Indiana
city: Ypsilanti
country: United States
facility: LEO Pharma investigational site
state: Michigan
city: Tulsa
country: United States
facility: LEO Pharma investigational site
state: Oklahoma
city: Medford
country: United States
facility: LEO Pharma investigational site
state: Oregon
city: San Antonio
country: United States
facility: LEO Pharma investigational site
state: Texas
city: Red Deer
country: Canada
facility: LEO Pharma investigational site
state: Alberta
city: Hamilton
country: Canada
facility: LEO Pharma investigational site
state: Ontario
city: Montreal
country: Canada
facility: LEO Pharma investigational site
state: Quebec
city: Montréal
country: Canada
facility: LEO Pharma investigational site
state: Quebec
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: