A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects with Moderate-to-Severe Atopic Dermatitis

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

This is a 24-week randomized, double blind, placebo controlled, parallel group, dose ranging, Phase 2b study designed to assess the efficacy of different doses and dose regimens of Etokimab compared to placebo in adult subjects with moderate to severe atopic dermatitis (AD).

This study will also assess the safety, tolerability, and pharmacokinetics of Etokimab. The study will have a total of 11 in-office visits (there is a 4-week screening period when some tests and assessments will be done to see if the study is suitable for you, followed by a 16-week treatment period, where you will attend the study center 8 times, then there will be an 8-week safety follow-up period, where you will attend the study center twice).

Visits throughout the study include a physical exam, blood draws, urine sampling, ECG’s, assessments, and administration of study drug  subcutaneously (SC) during selected onsite visits by qualified professionals and other assessments which will be reviewed in detail at your screening visit.

All services are provided at no cost.

 

Description

  • Physical exam and assessments of study condition to be provided at no cost by an experienced provider.
  • No insurance necessary.
  • Compensation will be provided at the end of study participation.

Details
Condition Skin Infections/Disorders, Atopic Dermatitis, Eczema (Atopic Dermatitis), Dermatitis - Atopic, Dermatitis, Atopic
Clinical Study IdentifierTX218128
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible male and female adult participants between the ages of 18 to 75 years with a diagnosis of moderate to severe eczema for at least six months
Female subjects cannot plan to be pregnant or breast feeding during the study and male subjects must agree to use contraception during the study, and for at least 3 months after receiving the last dose of study drug
Subjects must be available for the 11 office visits for the duration of the study and be willing to comply with all study instructions
Several other restrictions and criteria may apply that the study doctor will review with you to determine if you qualify to enter the study
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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