Atopic Dermatitis

Last updated: October 31, 2023
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

TX321918
SFY17915
  • Ages 18-100
  • All Genders

Study Summary

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses in Adult Participants With Moderate to Severe Atopic Dermatitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must be 18 years of age (when signing informed consent form)
  • Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
  • Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments

Exclusion

Exclusion Criteria:

  • Skin co-morbidity that would adversely affect the ability to undertake AD assessments
  • Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior to screening
  • Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to screening
  • Prior receipt of two or more doses of Pneumovax 23 at any time
  • Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening
  • Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
  • Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine

Study Design

Study Start date:
Estimated Completion Date:

Study Description

Condition: Atopic Dermatitis

Clinical Trial Identifier: NCT06015308

Sponsor: Sanofi

Looking for participates within a 30-mile radius of the study location.

Connect with a study center

  • AMR Fort Myers

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

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