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.

Atopic Dermatitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725722
• Other study ID #: LP0133-1275
• Status: Completed
• Phase: Phase 2
• Start date: December 28, 2018
• Est. completion date: May 19, 2020

Study information

• Verified date: June 2021
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Delgocitinib cream
Cream for topical application
• Delgocitinib cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Locations

Country	Name	City	State
Australia	Leo Pharma Investigational Site	Carlton
Australia	Leo Pharma Investigational Site	Darlinghurst
Australia	Leo Pharma Investigational Site	East Melbourne
Australia	Leo Pharma Investigational Site	Hectorville
Australia	Leo Pharma Investigational Site	Kogarah
Australia	Leo Pharma Investigational Site 1	Kogarah
Australia	Leo Pharma Investigational Site	Woolloongabba
Canada	Leo Pharma Investigational Site	Barrie	Ontario
Canada	Leo Pharma Investigational Site	Calgary	Alberta
Canada	Leo Pharma Investigational Site	Edmonton	Alberta
Canada	Leo Pharma Investigational Site	Fredericton	New Brunswick
Canada	Leo Pharma Investigational Site	Markham	Ontario
Canada	Leo Pharma Investigational Site	Mississauga	Ontaria
Canada	Leo Pharma Investigational Site	Peterborough	Ontario
Canada	Leo Pharma Investigational Site	Richmond Hill	Ontario
Canada	Leo Pharma Investigational Site	Surrey	British Columbia
Canada	Leo Pharma Investigational Site	Toronto	Ontario
Canada	Leo Pharma Investigational Site	Toronto	Ontario
Canada	Leo Pharma Investigational Site	Toronto	Ontario
Canada	Leo Pharma Investigational Site	Winnipeg	Manitoba
United States	Leo Pharma Investigational Site	Birmingham	Alabama
United States	Leo Pharma Investigational Site	Chicago	Illinois
United States	Leo Pharma Investigational Site	Detroit	Michigan
United States	Leo Pharma Investigational Site	Encino	California
United States	Leo Pharma Investigational Site	High Point	North Carolina
United States	Leo Pharma Investigational Site	Los Angeles	California
United States	Leo Pharma Investigational Site	Los Angeles	California
United States	Leo Pharma Investigational Site	New York	New York
United States	Leo Pharma Investigational Site	Philadelphia	Pennsylvania
United States	Leo Pharma Investigational Site	Rolling Hills Estates	California
United States	Leo Pharma Investigational Site	Santa Ana	California

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.	EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.; The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Mixed Model for Repeated Measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib doses and delgocitinib cream vehicle.	Week 0 to Week 8
Secondary	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.	vIGA-AD is an instrument used in clinical trials to assess the subject's global disease severity and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).; The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose-selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and the delgocitinib cream vehicle.	Week 0 to Week 8
Secondary	EASI75 at Week 8	EASI75 is defined as at least 75% reduction in EASI from baseline.	Week 0 to Week 8
Secondary	Time to vIGA-AD TS	The time to vIGA-AD TS response is defined as the time from baseline to first assessment of a vIGA-AD score of 0 (Clear) or 1 (Almost Clear) with =2-step improvement	Week 0 to Week 8