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

Part of paid clinical trials in La Jolla, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT03389893
Phase
PHASE4
Status
Terminated

Conditions

  • Atopic Dermatitis (AD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    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.)
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 25, 2018
Status verified
Sep 2021
Primary completion
Apr 3, 2020
Completion
Sep 9, 2020

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab w/OLE
    Participants will receive a loading dose of dupilumab (two 300 mg subcutaneous (subcut) injections (total of 600 mgs)) on Day 0, followed by 300 mg dose of dupilumab by subcut injection every 2 weeks (Days 14 and 28). Open Label Extension (OLE): Participants will begin a 10 week OLE on Day 42, beginning with a loading dose of two subcut administered injections (one 300 mg dose of dupilumab and one dose of placebo, in order to protect prior masking/blind).Participants will then maintain a regimen of 300 mg of dupilumab by subcut injection every two weeks through Day 98. The subcut injections will be administered in the abdomen (except for the 2 inches (5 cm) around the navel-not allowed), thighs, or upper arms. Injection sites will be rotated with each dose.
  • Placebo Comparator: Placebo Comparator w/OLE
    Participants will receive a loading dose of placebo (two placebo subcutaneous (subcut) injections) on Day 0 followed by one dose of placebo by subcut injections every 2 weeks (Days 14 and 28). Open Label Extension (OLE): Participants will begin a 10 week OLE on Day 42, beginning with a loading dose of dupilumab (two 300 mg subcut injections (total of 600 mgs)-protection of prior masking/blind maintained). Participants will then maintain a regimen of 300 mg of dupilumab by subcut injection every two weeks through Day 98. The subcut injections will be administered in the abdomen (except for the 2 inches (5 cm) around the navel-not allowed), thighs, or upper arms. Injection sites will be rotated with each dose.

Primary Outcome Measure

Staphylococcus Aureus Abundance on Lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up [ Time Frame: Day 28 (Post treatment initiation) ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Stanford UniversityStanfordCalifornia94305-
National Jewish HealthDenverColorado80206-
University of FloridaGainesvilleFlorida32611-
University of Rochester Medical CenterRochesterNew York14642-
Duke UniversityDurhamNorth Carolina27710-
Oregon Health Sciences UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CAChildren's Hospital Los Angeles· Los Angeles, CAStanford University· Stanford, CANational Jewish Health· Denver, COUniversity of Florida· Gainesville, FLUniversity of Rochester Medical Center· Rochester, NY

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