Back to resultsDose-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.
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Delgocitinib cream
Delgocitinib cream vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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.
Sites / Locations
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site 1
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
- Leo Pharma Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Delgocitinib cream 1 mg/g
Delgocitinib cream 3 mg/g
Delgocitinib cream 8 mg/g
Delgocitinib cream 20 mg/g
Delgocitinib cream vehicle
Arm Description
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream vehicle applied twice daily for 8 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
EASI75 at Week 8
EASI75 is defined as at least 75% reduction in EASI from baseline.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03725722
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 28, 2018 (Actual)
Primary Completion Date
May 19, 2020 (Actual)
Study Completion Date
May 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delgocitinib cream 1 mg/g
Arm Type
Experimental
Arm Description
Delgocitinib cream applied twice daily for 8 weeks
Arm Title
Delgocitinib cream 3 mg/g
Arm Type
Experimental
Arm Description
Delgocitinib cream applied twice daily for 8 weeks
Arm Title
Delgocitinib cream 8 mg/g
Arm Type
Experimental
Arm Description
Delgocitinib cream applied twice daily for 8 weeks
Arm Title
Delgocitinib cream 20 mg/g
Arm Type
Experimental
Arm Description
Delgocitinib cream applied twice daily for 8 weeks
Arm Title
Delgocitinib cream vehicle
Arm Type
Placebo Comparator
Arm Description
Delgocitinib cream vehicle applied twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Delgocitinib cream
Other Intervention Name(s)
LEO 124249 cream
Intervention Description
Cream for topical application
Intervention Type
Drug
Intervention Name(s)
Delgocitinib cream vehicle
Other Intervention Name(s)
LEO 124249 cream vehicle
Intervention Description
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Primary Outcome Measure Information:
Title
Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score.
Description
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.
Time Frame
Week 0 to Week 8
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Week 0 to Week 8
Title
EASI75 at Week 8
Description
EASI75 is defined as at least 75% reduction in EASI from baseline.
Time Frame
Week 0 to Week 8
Title
Time to vIGA-AD TS
Description
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
Time Frame
Week 0 to Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Leo Pharma Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274-7604
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Leo Pharma Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Leo Pharma Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Leo Pharma Investigational Site
City
Carlton
ZIP/Postal Code
3053
Country
Australia
Facility Name
Leo Pharma Investigational Site
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Leo Pharma Investigational Site
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Leo Pharma Investigational Site
City
Hectorville
ZIP/Postal Code
5073
Country
Australia
Facility Name
Leo Pharma Investigational Site 1
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Leo Pharma Investigational Site
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Leo Pharma Investigational Site
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Leo Pharma Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Mississauga
State/Province
Ontaria
ZIP/Postal Code
L5H 1G9
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 9M7
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2M 4J5
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2W 2N2
Country
Canada
Facility Name
Leo Pharma Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing URL
https://www.leopharmatrials.com/For-professionals
Learn more about this trial
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.
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