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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02379052
First received: February 27, 2015
Last updated: May 2, 2017
Last verified: May 2017
  Purpose
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 patients with active, moderate to severe eosinophilic esophagitis (EoE). The study comprises 2 sections with double-blinded, randomized, placebo-controlled study and an open label extension (OLE) to evaluate long-term safety.

Condition Intervention Phase
Eosinophilic Esophagitis Drug: Dupilumab Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients With Active Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Change in the Straumann Dysphagia Instrument (SDI) patient reported outcome (PRO) score [ Time Frame: baseline to week 10 ]

Secondary Outcome Measures:
  • Percent change in Eosinophilic Esophagitis Activity Index (EEsAI) PRO score [ Time Frame: baseline to week 12 ]
  • Change in EEsAI PRO score [ Time Frame: baseline to week 12 ]
  • Change in Adult Eosinophilic Esophagitis Quality of Life (EoE-QOL-A) PRO score [ Time Frame: baseline to week 12 ]
  • Percent change in the SDI PRO score [ Time Frame: baseline to week 12 ]
  • Percentage of patients with SDI PRO response at week 12 [ Time Frame: At week 12 ]
    Response is defined as a decrease of at least 3 points on the SDI compared to baseline

  • Percentage of patients who achieve ≥40% improvement in EEsAI PRO score [ Time Frame: baseline to week 12 ]
  • Change in peak esophageal intraepithelial eosinophils/high power field (eos/hpf) (400X) [ Time Frame: baseline to week 12 ]
  • Percentage of patients with use of rescue medication or procedure (eg, esophageal dilation) through week 12 [ Time Frame: baseline to week 12 ]
  • Change in SDI PRO and EEsAI PRO scores [ Time Frame: baseline to week 28 ]
  • Incidence of treatment-emergent adverse events (AEs) [ Time Frame: baseline to week 12 ]

Enrollment: 47
Study Start Date: January 2015
Estimated Study Completion Date: September 2019
Primary Completion Date: March 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dupilumab SC
Participants will receive dupilumab SC from day 1 to week 11.
Drug: Dupilumab
Other Name: REGN668(SAR231893)
Experimental: Placebo
Participants will receive placebo SC from day 1 to week 11.
Drug: Placebo

Detailed Description:

This is a phase 2, multicenter study that consists of: 1) a double-blind, randomized, placebo-controlled study investigating the efficacy, safety, tolerability, PK, and immunogenicity of dupilumab in adult patients with EoE, followed by 2) an OLE to evaluate long-term safety.

The study will consist of 4 periods: screening, double-blind treatment (with or without follow-up), OLE treatment, and OLE follow-up. The maximum duration of the double-blind study is approximately 33 weeks including screening and follow-up. The expected duration of the OLE is up to an additional 2 years with a 12 week follow-up period.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion criteria:

  1. Documented diagnosis of EoE by endoscopy prior to or at screening
  2. History of on average at least 2 episodes of dysphagia (with intake of solids off anti-inflammatory therapy) per week in the 4 weeks prior to screening and on average at least 2 episodes of documented dysphagia per week in the weeks between screening and baseline; dysphagia is defined as trouble swallowing solid food, or having solid food stick, by patient report
  3. Must remain on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups
  4. Documented history of or presence of any of the following: allergic disease (eg, allergic asthma, allergic rhinitis, AD, or food allergies), peripheral eosinophil counts ≥0.25 GI/L, or serum total Immunoglobulin E (IgE) ≥100 kU/L
  5. Participation in R688-EE-1324 clinical trial of dupilumab for EoE and received study treatment and adequately completed the assessments required for at least the treatment period of the double-blind study as defined in the protocol (for OLE only).

Key Exclusion Criteria:

  1. Prior participation in a dupilumab (anti-IL-4R) clinical trial
  2. Other causes of esophageal eosinophilia or the following diseases: hypereosinophilic syndromes, Churg-Strauss vasculitis, and eosinophilic gastroenteritis
  3. History of achalasia, active Helicobacter pylori infection, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery prior to screening
  4. Any esophageal stricture unable to be passed with a standard, diagnostic, adult (9 to10 mm) upper endoscope or any critical esophageal stricture that requires dilation at screening
  5. History of bleeding disorders or esophageal varices
  6. Use of chronic aspirin, nonsteroidal agents, or anti-coagulants within 2 weeks prior to screening. Patients should not stop these agents solely to become eligible for entry into this study
  7. Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening
  8. Use of systemic corticosteroids within 3 months or swallowed topical corticosteroids within 3 months prior to screening
  9. Use of inhaled (pulmonary or nasal) topical corticosteroids within 3 months prior to screening and during the study, except stable dose for at least 3 months prior to screening biopsy, which cannot be changed during the study
  10. Treatment with oral immunotherapy (OIT) within 6 months prior to screening
  11. Allergen immunotherapy unless on stable dose for at least 1 year prior to screening
  12. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
  13. Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab and led to study treatment discontinuation (OLE only)

Note: The list of inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02379052

Locations
United States, Idaho
Idaho Falls, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Maryland
Chevy Chase, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Plymouth, Minnesota, United States
United States, New York
New York, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Fairfax, Virginia, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02379052     History of Changes
Other Study ID Numbers: R668-EE-1324
Study First Received: February 27, 2015
Last Updated: May 2, 2017

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2017