Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With Atopic Dermatitis



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:2/17/2018
Start Date:August 15, 2015
End Date:July 15, 2016

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A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects With Moderate-to-Severe Atopic Dermatitis

To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis

This is a Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the
efficacy and safety of MEDI9929 administered subcutaneously to adult subjects with moderate
to severe Atopic Dermatitis. Subjects will be randomized in a 1:1 fashion and will be
stratified at screening. Approximately 100 subjects are planned to be randomized at
approximately 35 sites in 6 countries

Inclusion Criteria:

- AD meeting Hanifin and Rajka criteria

- Age 18-75 years inclusive at screening

- Atopic dermatitis that affects greater than/equal to 10% body surface area

- Moderate to severe AD

- Effective birth control in line with protocol details

Exclusion Criteria:

- Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis

- Hepatitis B, C or HIV

- Pregnant or breastfeeding

- History of anaphylaxis following any biologic therapy

- History of clinically significant infections within 4 weeks prior to Visit 3

- Diagnosis of helminth parasitic infection within 6 months to screening

- History of Cancer except basal cell

- Receipt of any marketed or investigational biologic agent within 4 months to visit 3

- Any clinically relevant abnormal finding

- Major surgery within 8 weeks prior to Visit 1
We found this trial at
9
sites
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Tampa, FL
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ACT,
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from
Arlington Hts, IL
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from
Berlin, NJ
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from
Carmel, IN
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Charlotte, North Carolina 28207
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from
Charlotte, NC
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from
Indianapolis, IN
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North Miami Beach, Florida 33162
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North Miami Beach, FL
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from
Portland, OR
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