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

PHASE4TerminatedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 25, 2018

Primary Completion Date

April 3, 2020

Study Completion Date

September 9, 2020

Conditions
Atopic Dermatitis (AD)
Interventions
DRUG

Dupilumab

Dupilumab, an interleukin (IL)-4 receptor alpha (IL-4Rα) antagonist, is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. (FDA approved on March 28, 2017.)

DRUG

Placebo

Placebo will contain the identical formulation as the dupilumab formulation without the active mAb and will be given by exactly the same route and schedule through Day 28.

Trial Locations (9)

14642

University of Rochester Medical Center, Rochester

19104

University of Pennsylvania, Philadelphia

27710

Duke University, Durham

32611

University of Florida, Gainesville

80206

National Jewish Health, Denver

90027

Children's Hospital Los Angeles, Los Angeles

92093

University of California San Diego, La Jolla

94305

Stanford University, Stanford

97239

Oregon Health Sciences University, Portland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

collaborator

Sanofi

INDUSTRY

collaborator

Atopic Dermatitis Research Network

OTHER

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03389893 - Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis | Biotech Hunter | Biotech Hunter