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

Use our guide to learn which trials are right for you!

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
1966
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
Birmingham, Alabama 35209
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
?
mi
from 91732
Carlton,
Click here to add this to my saved trials
Chicago, Illinois 60611
1728
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Encino, California 91436
?
mi
from 91732
Encino, CA
Click here to add this to my saved trials
High Point, North Carolina 27262
1997
mi
from 91732
High Point, NC
Click here to add this to my saved trials
Houston, Texas 77065
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90025
24
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33144
2322
mi
from 91732
Miami, FL
Click here to add this to my saved trials
New York, New York 10021
2351
mi
from 91732
New York, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Rolling Hills Estates, California 90274
?
mi
from 91732
Rolling Hills Estates, CA
Click here to add this to my saved trials
Santa Ana, California 92701
78
mi
from 91732
Santa Ana, CA
Click here to add this to my saved trials