Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:12 - Any
Updated:3/21/2019
Start Date:September 24, 2018
End Date:March 7, 2023
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com
Phone:844-734-6643

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A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

The primary objectives of the study by study part are:

Part A:

To determine the treatment effect of dupilumab compared with placebo in adult and adolescent
patients with EoE after 24 weeks of treatment as assessed by histological and clinical
measures, and to inform/confirm the final sample size determination for Part B.

Part B:

To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and
adolescent patients with EoE after 24 weeks of treatment as assessed by histological and
clinical measures.

Part C:

To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients
with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.

The secondary objectives of the study are:

- To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up
to 52 weeks in adult and adolescent patients with EoE

- To explore the relationship between dupilumab concentration and responses in adult and
adolescent patients with EoE, using descriptive analyses


Key Inclusion Criteria (Parts A & B):

1. A documented diagnosis of EoE by endoscopic biopsy prior to screening

2. Baseline endoscopic biopsies with a demonstration on central reading of
intraepithelial eosinophilic infiltration

3. History (by patient report) of an average of at least 2 episodes of dysphagia (with
intake of solids) per week in the 4 weeks prior to screening

Key Exclusion Criteria (Parts A & B):

1. Body weight ≤40 kg

2. Prior participation in a dupilumab clinical trial, or past or current treatment with
dupilumab

3. Initiation or change of a food-elimination diet regimen or re-introduction of a
previously eliminated food group in the 6 weeks prior to screening.

4. Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic
syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)

5. Active Helicobacter pylori infection

6. History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior
esophageal surgery

7. Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm
upper endoscope or any critical esophageal stricture that requires dilation at
screening

8. History of bleeding disorders or esophageal varices

9. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed
during the study

Key Exclusion Criteria (Part C):

1. Participants who, during Part A or Part B, developed a serious adverse event (SAE)
and/or adverse event (AE) deemed related to study drug, which in the opinion of the
investigator could indicate that continued treatment with study drug may present an
unreasonable risk for the participant

2. Participants who became pregnant Part A or Part B

3. Participants who are prematurely discontinued from study drug due to an AE (patients
who are prematurely discontinued from study drug due to lack of efficacy are eligible
to enter Part C)

4. Patients who did not undergo endoscopy with biopsies prior to receiving rescue
treatment

Note: Other inclusion/ exclusion criteria apply
We found this trial at
17
sites
Ann Arbor, Michigan 48103
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Dublin, OH
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Englewood, Ohio 45415
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Englewood, OH
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Garland, Texas 75044
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Garland, TX
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Iowa City, Iowa 52242
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Iowa City, IA
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Little Rock, Arkansas
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Little Rock, AR
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Los Angeles, California
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Los Angeles, CA
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Memphis, Tennessee
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Memphis, TN
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Mentor, Ohio 44060
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Mentor, OH
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Mountain View, California
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Mountain View, CA
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Park Ridge, Illinois 60068
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Park Ridge, IL
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Plymouth, Minnesota 55441
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Plymouth, MN
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Rolling Hills Estates, California 90274
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Rolling Hills Estates, CA
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San Antonio, Texas
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San Antonio, TX
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Urbana, IL
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