Phase 2b Study to Evaluate the Efficacy and Safety of GBR 830 in Adults With Moderate to Severe Atopic Dermatitis



Status:Recruiting
Conditions:Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:May 31, 2018
End Date:April 2020
Contact:Priya Raina
Email:clinicaltrialsdisclosuredesk@glenmarkpharma.com
Phone:1-201-684-8000

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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of GBR 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.

Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate
the efficacy, safety and tolerability of GBR 830 in adults with moderate to severe atopic
dermatitis.


Inclusion Criteria:

- Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis
for >1 year as defined by American Academy of Dermatology Consensus Criteria.

- Atopic dermatitis involvement of ≥10% of body surface area and IGA score of ≥3 at
screening and baseline.

- EASI score of ≥12 at screening or ≥16 at baseline.

- IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is
moderate and 4 is severe)

- Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3
over the previous 24 hours.

Exclusion Criteria:

- Pregnant or lactating women.

- Prior treatment with GBR 830

- Treatment with biologics

- Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy
within 4 weeks of baseline

- Active chronic or acute infection requiring systemic treatment
We found this trial at
26
sites
Tampa, Florida 33624
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Birmingham, Alabama 35209
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Birmingham, AL
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Bridgeport, Connecticut 06606
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Calgary,
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Chattanooga, Tennessee 37421
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Clovis, California 93711
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Forest Hills, New York 11375
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Hazleton, Pennsylvania
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Hazleton, PA
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Houston, TX
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Long Beach, California
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Medford, Oregon 97504
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New Orleans, Louisiana 70115
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Newnan, Georgia 30263
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Newport News, Virginia 23606
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Pensacola, Florida 32504
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Philadelphia, Pennsylvania 19103
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Plainfield, Indiana 46168
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Richmond, Virginia 23220
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Rolling Hills Estates, California 90274
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Saint Louis, Missouri 63117
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San Antonio, Texas
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Santa Monica, California 90404
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Verona, New Jersey 07044
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Verona, NJ
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Waco, TX
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West Des Moines, Iowa 50265
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West Des Moines, IA
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