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.



Status:Recruiting
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:December 28, 2018
End Date:December 2019
Contact:LEO Pharma A/S
Email:disclosure@leo-pharma.com
Phone:(+1) 877-557-1168

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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.

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).


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.
We found this trial at
13
sites
Detroit, Michigan 48202
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Detroit, MI
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Birmingham, Alabama 35209
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Birmingham, AL
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Carlton,
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Chicago, Illinois 60611
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Chicago, IL
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Encino, California 91436
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Encino, CA
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High Point, North Carolina 27262
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High Point, NC
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Houston, Texas 77065
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Houston, TX
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Los Angeles, California 90025
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Los Angeles, CA
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Miami, Florida 33144
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Miami, FL
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New York, New York 10021
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New York, NY
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Rolling Hills Estates, California 90274
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Rolling Hills Estates, CA
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Santa Ana, California 92701
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Santa Ana, CA
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