TerminatedPhase 4

Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis

Stopped: Due to inability to meet accrual goals within the funding period.

United States72 participantsStarted 2018-07-25

Plain-language summary

The purpose of this study is to understand the effect that T helper 2 (Th2) blockade has on well-described pathophysiological features of Atopic Dermatitis (AD), for example: barrier, epidermal activation, dysbiosis and epidermal lipids.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓-FDA approved methods of birth control include hormonal contraceptives, intrauterine device, double barrier contraception (i.e., condom plus diaphragm), or male partner with documented vasectomy.
✓--\*Menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone of ≥25 U/mL must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception.

What they're measuring

Staphylococcus Aureus Abundance on Lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

Timeframe: Day 28 (Post treatment initiation)

Trial details

NCT IDNCT03389893

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-04-03

Results submitted2021-04-02

View on ClinicalTrials.gov More Atopic Dermatitis (AD) trials