NCT02525094

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	MEDI9929	Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
BIOLOGICAL	Placebo	Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.

Timeline

• Start date: 2015-08-15
• Primary completion: 2016-05-09
• Completion: 2016-07-15
• First posted: 2015-08-17
• Last updated: 2018-02-15
• Results posted: 2018-02-15

Locations

29 sites across 6 countries: United States, Australia, Canada, Germany, Hungary, New Zealand

Regulatory

• FDA-regulated drug study