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 |
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
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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