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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02379052
• Date of registration: 27/02/2015
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)
• Scientific title: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients With Active Eosinophilic Esophagitis
• Date of first enrolment: May 12, 2015
• Target sample size: 47
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02379052
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion 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 participant 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. Participants 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 participant's potential participation in this clinical
trial.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Dupilumab

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophils of 3 Esophageal Regions at Week 12 [Time Frame: Baseline, Week 12]

Percentage of Participants Achieving a Reduction of = 3 Points in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score From Baseline at Week 12 [Time Frame: Baseline, Week 12]

Absolute Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 10 [Time Frame: Baseline, Week 10]

Absolute Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EoE-QOL-A) Score at Week 12 [Time Frame: Baseline, Week 12]

Percent Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 12 [Time Frame: Baseline, Week 12]

Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 12 [Time Frame: Baseline, Week 12]

Percent Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 12 [Time Frame: Baseline, Week 12]

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

Percentage of Participants With Use of Rescue Medication or Procedure (e.g., Esophageal Dilation) Through Week 12 [Time Frame: Baseline through Week 12]

Percent of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Study [Time Frame: Baseline through Week 28]

Percentage of Participants Achieving = 40% Improvement in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score From Baseline at Week 10 [Time Frame: Baseline, Week 10]

Percentage of Participants Achieving = 40% Improvement in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score From Baseline at Week 12 [Time Frame: Baseline, Week 12]

Absolute Change From Baseline in Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) by Feature at Week 12 [Time Frame: Baseline, Week 12]

Percent Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 10 [Time Frame: Baseline, Week 10]

Percentage of Participants Achieving a Reduction of = 3 Points in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score From Baseline at Week 10 [Time Frame: Baseline, Week 10]

Secondary ID(s)

R668-EE-1324

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi

Results

• Results available: Yes
• Date Posted: 28/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02379052