To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adult Patients With Moderate-to-severe Atopic Dermatitis (AD)



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:6/14/2018
Start Date:March 2016
End Date:June 2017

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A Phase IIa, Double-Blind, Randomised, Placebo-controlled, Exploratory Study to Evaluate the Safety, Biological Activity and Pharmacokinetics of GBR 830 in Adult Patients With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to determine the effect of GBR 830 on biomarkers in AD/ eczema
to enable further studies in this indication.

Approximately 40 patients who meet eligibility criteria will undergo baseline assessments and
randomize to receive GBR 830 or placebo. Safety and tolerability of GBR 830 will be evaluated
in patients with AD/eczema.

Inclusion Criteria:

- Male or female, 18 years or older

- Moderate to severe atopic dermatitis that has been present for greater than 1 year
from screening with BSA ≥10%.

Exclusion Criteria:

- Treatment with systemic corticosteroids within 4 weeks before randomization, and
topical steroids/tacrolimus and or/pimecrolimus within 1 week before the randomization
(except emollients, and mild steroids (class 6 or 7)

- Any cell-depleting agents including but not limited to rituximab: within 6 months
prior to the baseline visit or until lymphocyte and CD 19+ lymphocyte counts return to
normal, whichever is longer. Other biologics: within 5 half-lives or 8 weeks prior to
the baseline visit, whichever is longer. Allergen immunotherapy within 6 months before
the baseline visit.

- Patient with history of serious local infection and systemic infection Patient with
history or current evidence of diseases such as tuberculosis, malignant disease, other
inflammatory or autoimmune disease or HIV or Hepatitis B or C positive.

- Pregnant or breast-feeding women or women planning to become pregnant or breastfeed
during the study or unwilling to use adequate birth control, if of reproductive
potential and sexually active
We found this trial at
13
sites
New York, New York 10029
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Berlin, New Jersey 08009
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Berlin, NJ
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Dallas, Texas 75230
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Dallas, TX
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Fairborn, Ohio 45324
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Fairborn, OH
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Katy, TX
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Los Angeles, California
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Los Angeles, CA
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Markham,
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Raleigh, North Carolina 27612
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Raleigh, NC
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Rogers, Arkansas 72759
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Rogers, AR
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Saint Louis, Missouri 63117
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Saint Louis, MO
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San Diego, California 92123
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San Diego, CA
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Tampa, Florida 33624
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Tampa, FL
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Webster, Texas 77598
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Webster, TX
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