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

Study Description

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Brief Summary:

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 EoE.

The secondary objectives of the study are:

• To assess the safety, tolerability, and immunogenicity of SC doses of dupilumab in adult patients 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 patients with EoE

Condition or disease	Intervention/treatment	Phase
Eosinophilic Esophagitis	Drug: Dupilumab; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	47 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (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
Actual Study Start Date :	June 3, 2015
Actual Primary Completion Date :	February 17, 2017
Actual Study Completion Date :	July 10, 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Dupilumab SC; Participants will receive dupilumab SC from baseline (day 1) to week 11.	Drug: Dupilumab; Other Names: DUPIXENT®; REGN668(SAR231893)
Experimental: Placebo; Participants will receive placebo SC from baseline (day 1) to week 11.	Drug: Placebo

Outcome Measures

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Primary Outcome Measures :

1. Change in the Straumann Dysphagia Instrument (SDI) patient reported outcome (PRO) score from baseline to week 10 [ Time Frame: Baseline to week 10 ]

Secondary Outcome Measures :

1. Percent change in weekly Eosinophilic Esophagitis Activity Index (EEsAI) PRO score from baseline to week 10 [ Time Frame: Baseline to week 10 ]
2. Change in weekly EEsAI PRO score from baseline to week 10 [ Time Frame: Baseline to week 10 ]
3. Percent change in weekly EEsAI PRO score from baseline to week 12 [ Time Frame: Baseline to week 12 ]
4. Change in weekly EEsAI PRO score from baseline to week 12 [ Time Frame: Baseline to week 12 ]
5. Percent change in the SDI PRO score from baseline to week 10 [ Time Frame: Baseline to week 10 ]
6. Percent change in the SDI PRO score from baseline to week 12 [ Time Frame: Baseline to week 12 ]
7. Change in the SDI PRO score from baseline to week 12 [ Time Frame: Baseline to week 12 ]
8. Change in Adult Eosinophilic Esophagitis Quality of Life (EoE-QOL-A) PRO score from baseline to week 12 [ Time Frame: Baseline to week 12 ]
9. Percentage of patients with SDI PRO response at week 10; where response is defined as a decrease of at least 3 points on the SDI compared to baseline [ Time Frame: Baseline to week 10 ]
10. Percentage of patients who achieve ≥40% improvement in EEsAI score from baseline to week 10 [ Time Frame: Baseline to week 10 ]
11. Percent change in overall peak esophageal intraepithelial Eosinophils/high power field (eos/hpf) (400X) from baseline to week 12 [ Time Frame: Baseline to week 12 ]
12. Change in Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFs) (endoscopy visual anatomical score) from baseline to week 12 [ Time Frame: Baseline to week 12 ]
13. Percentage of patients with use of rescue medication or procedure (eg, esophageal dilation) through week 12 [ Time Frame: Baseline to week 12 ]
14. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to week 28 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older 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 (e.g, allergic asthma, allergic rhinitis, atopic dermatitis (AD), or food allergies), peripheral eosinophil counts ≥0.25 GI/L, or serum total Immunoglobulin E (IgE) ≥100 kU/L

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

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

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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

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Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02379052 History of Changes
Other Study ID Numbers:	R668-EE-1324
First Posted:	March 4, 2015
Last Update Posted:	February 19, 2018
Last Verified:	February 2018

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; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs