Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)

Part of paid clinical trials in Idaho Falls, Idaho.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02379052
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult participants with active, moderate to severe Eosinophilic Esophagitis (EoE). The secondary objectives of the study are: * To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult participants with active, moderate to severe EoE * To assess the effect of dupilumab on esophageal eosinophilic infiltration * To evaluate the pharmacokinetics (PK) of dupilumab in adult participants with EoE

Key Dates

Start date
May 12, 2015
Status verified
Feb 2020
Primary completion
Feb 17, 2017
Completion
Jul 10, 2017

Study Design

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

Arms

  • Experimental: Dupilumab 300 mg QW
    Participants received SC dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
  • Experimental: Placebo
    Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.

Primary Outcome Measure

Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10 [ Time Frame: Baseline, Week 10 ]

Locations (14)

FacilityCityStateZIPSite coordinators
-Idaho FallsIdaho--
-ChicagoIllinois--
-UrbanaIllinois--
-IndianapolisIndiana--
-Iowa CityIowa--
-Chevy ChaseMaryland--
-BostonMassachusetts--
-New YorkNew York--
-AshevilleNorth Carolina--
-Chapel HillNorth Carolina--
-CincinnatiOhio--
-PhiladelphiaPennsylvania--
-Salt Lake CityUtah--
-FairfaxVirginia--

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