A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis

  • STATUS
    Not Recruiting
  • End date
    Mar 24, 2022
  • participants needed
    300
  • sponsor
    Amgen
Updated on 28 February 2021
remission
calcineurin inhibitor
atopy
eczema

Summary

This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe AD.

Description

All subjects will receive a SC dose of either investigational product or placebo as the first dose on day 1.

Subjects who are determined to be non-responders in Part A will receive tezepelumab SC Q2W following completion of all week 16 study activities. Nonresponders are defined as those subjects who have not achieved at least a 50% improvement in EASI at week 16 compared to baseline (day 1).

Safety follow-up is 12 weeks after the EOT visit (14 weeks after the final dose of investigational product).

Details
Condition ATOPIC DERMATITIS, Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczéma (Dermatite Atopique), Dermatite Atopique
Treatment Placebo, Tezepelumab
Clinical Study IdentifierNCT03809663
SponsorAmgen
Last Modified on28 February 2021

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note