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.
NCT ID: NCT03725722
Last Updated: 2025-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
251 participants
INTERVENTIONAL
2018-12-28
2020-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Delgocitinib cream 1 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream
Cream for topical application
Delgocitinib cream 3 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream
Cream for topical application
Delgocitinib cream 8 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream
Cream for topical application
Delgocitinib cream 20 mg/g
Delgocitinib cream applied twice daily for 8 weeks
Delgocitinib cream
Cream for topical application
Delgocitinib cream vehicle
Delgocitinib cream vehicle applied twice daily for 8 weeks
Delgocitinib cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_DIRECTOR
LEO Pharma
Locations
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Leo Pharma Investigational Site
Birmingham, Alabama, United States
Leo Pharma Investigational Site
Encino, California, United States
Leo Pharma Investigational Site
Los Angeles, California, United States
Leo Pharma Investigational Site
Los Angeles, California, United States
Leo Pharma Investigational Site
Rolling Hills Estates, California, United States
Leo Pharma Investigational Site
Santa Ana, California, United States
Leo Pharma Investigational Site
Chicago, Illinois, United States
Leo Pharma Investigational Site
Detroit, Michigan, United States
Leo Pharma Investigational Site
New York, New York, United States
Leo Pharma Investigational Site
High Point, North Carolina, United States
Leo Pharma Investigational Site
Philadelphia, Pennsylvania, United States
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 1
Kogarah, , Australia
Leo Pharma Investigational Site
Kogarah, , Australia
Leo Pharma Investigational Site
Woolloongabba, , Australia
Leo Pharma Investigational Site
Calgary, Alberta, Canada
Leo Pharma Investigational Site
Edmonton, Alberta, Canada
Leo Pharma Investigational Site
Surrey, British Columbia, Canada
Leo Pharma Investigational Site
Winnipeg, Manitoba, Canada
Leo Pharma Investigational Site
Fredericton, New Brunswick, Canada
Leo Pharma Investigational Site
Mississauga, Ontaria, Canada
Leo Pharma Investigational Site
Barrie, Ontario, Canada
Leo Pharma Investigational Site
Markham, Ontario, Canada
Leo Pharma Investigational Site
Peterborough, Ontario, Canada
Leo Pharma Investigational Site
Richmond Hill, Ontario, Canada
Leo Pharma Investigational Site
Toronto, Ontario, Canada
Leo Pharma Investigational Site
Toronto, Ontario, Canada
Leo Pharma Investigational Site
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LP0133-1275
Identifier Type: -
Identifier Source: org_study_id
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