Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:9/20/2018
Start Date:January 2017
End Date:June 2018

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

A Randomised, Double-blind, Placebo-controlled, Phase 2b Study to Assess the Efficacy and Safety of Orally Administered DS107 in Patients With Moderate to Severe Atopic Dermatitis

The purpose of this study is to determine whether orally administered DS107 (1g and 2g doses)
is effective in the treatment of moderate to severe atopic dermatitis.

Oral DS107 capsules will be administered for 8 weeks and will be compared against placebo.

The study will enroll approximately 300 subjects.

The study will consist of 3 treatment arms, each consisting of approximately 100 subjects.

Treatment Arm 1 will receive 1g Oral DS107 daily. Treatment Arm 2 will receive 2g Oral DS107
daily. Treatment Arm 3 will receive placebo daily.

The primary objective of the study is to assess the efficacy and safety of daily 1g and 2g
doses of Oral DS107 versus placebo.

Subjects will come to the clinic on 7 occasions: Screening, Baseline, Week 2, Week 4, Week 6,
Week 8 (end of treatment/early termination) and Week 10 (follow-up). The primary efficacy
variable will be the IGA (Investigator's Global Assessment). Secondary efficacy variables
will include IGA, EASI (Eczema Area and Severity Index), and NRS (Numeric Rating Scale),

Inclusion Criteria:

- Subjects with a clinically confirmed diagnosis of active Atopic Dermatitis according
to Hanafin and Rajka criteria

- Subjects with moderate to severe Atopic Dermatitis at baseline as defined by an IGA of
minimum 3 at baseline

- Subjects with Atopic Dermatitis covering a minimum 10% of the body surface area at
baseline

- Male or female subjects who are aged 18 years and older on the day of signing the
informed consent form (ICF)

Exclusion Criteria:

- Subjects with other skin conditions that might interfere with Atopic Dermatitis
diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and
fungal skin infections) as assessed by the Investigator

- Subjects who have used systemic treatments (other than biologics) that could affect
Atopic Dermatitis less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids,
methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and
oral/injectable corticosteroids. Intranasal corticosteroids and inhaled
corticosteroids for stable medical conditions are allowed

- Subjects who have used any topical medicated treatment for Atopic Dermatitis two weeks
prior to start of treatment/Baseline (Day 0), including but not limited to, topical
corticosteroids, tars and bleach

- Subjects who use topical products containing urea, ceramides or hyaluronic acid two
weeks prior to Baseline

- Subjects who have a history of hypersensitivity to any substance in Oral DS107 or
placebo capsules

- Subjects who have any clinically significant controlled or uncontrolled medical
condition or laboratory abnormality that would, in the opinion of the investigator,
put the subject at undue risk or interfere with the interpretation of study results

- Subjects with significant uncontrolled cardiovascular, neurologic, malignant,
psychiatric, respiratory or hypertensive disease, as well as diabetes and arthritis or
any other illness that, in the opinion of the investigator, is likely to interfere
with completion of the study

- Subjects with chronic infectious disease (e.g. hepatitis B, hepatitis C or infection
with human immunodeficiency virus)
We found this trial at
2
sites
Philadelphia, Pennsylvania
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Cape Town,
?
mi
from
Cape Town,
Click here to add this to my saved trials