Clinical trial NCT03725722: Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.
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 Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 251
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: This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).


Eligibility criteria: Key Inclusion Criteria:

* Age 18 years and above.
* Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
* History of AD for ≥1 year.
* AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
* Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.

Key Exclusion Criteria:

* AD lesion(s) on scalp at screening and/or baseline.
* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
* Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity 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, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
* Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
* Receipt of live attenuated vaccines within 4 weeks prior to baseline.
* Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
* History of any active skin infection within 1 week prior to baseline.
* Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.

Primary outcomes:
measure: Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.
timeFrame: Week 0 to Week 8
Secondary outcomes:
measure: Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of 0 (Clear) or 1 (Almost Clear) With ≥2-step Improvement (vIGA-AD TS) From Baseline to Week 8.
timeFrame: Week 0 to Week 8
measure: EASI75 at Week 8
timeFrame: Week 0 to Week 8
measure: Time to vIGA-AD TS
timeFrame: Week 0 to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Leo Pharma Investigational Site
state: Alabama
city: Encino
country: United States
facility: Leo Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: Leo Pharma Investigational Site
state: California
city: Los Angeles
country: United States
facility: Leo Pharma Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: Leo Pharma Investigational Site
state: California
city: Santa Ana
country: United States
facility: Leo Pharma Investigational Site
state: California
city: Chicago
country: United States
facility: Leo Pharma Investigational Site
state: Illinois
city: Detroit
country: United States
facility: Leo Pharma Investigational Site
state: Michigan
city: New York
country: United States
facility: Leo Pharma Investigational Site
state: New York
city: High Point
country: United States
facility: Leo Pharma Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Leo Pharma Investigational Site
state: Pennsylvania
city: Carlton
country: Australia
facility: Leo Pharma Investigational Site
city: Darlinghurst
country: Australia
facility: Leo Pharma Investigational Site
city: East Melbourne
country: Australia
facility: Leo Pharma Investigational Site
city: Hectorville
country: Australia
facility: Leo Pharma Investigational Site
city: Kogarah
country: Australia
facility: Leo Pharma Investigational Site 1
city: Kogarah
country: Australia
facility: Leo Pharma Investigational Site
city: Woolloongabba
country: Australia
facility: Leo Pharma Investigational Site
city: Calgary
country: Canada
facility: Leo Pharma Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Leo Pharma Investigational Site
state: Alberta
city: Surrey
country: Canada
facility: Leo Pharma Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Leo Pharma Investigational Site
state: Manitoba
city: Fredericton
country: Canada
facility: Leo Pharma Investigational Site
state: New Brunswick
city: Mississauga
country: Canada
facility: Leo Pharma Investigational Site
state: Ontaria
city: Barrie
country: Canada
facility: Leo Pharma Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Leo Pharma Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: Leo Pharma Investigational Site
state: Ontario
city: Richmond Hill
country: Canada
facility: Leo Pharma Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Leo Pharma Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Leo Pharma Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Leo Pharma Investigational Site
state: Ontario
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: