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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Placebo; Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02379052

R668-EE-1324

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups

Dupilumab 300 mg QW

Experimental group

Description:

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.

Treatment:

Drug: Dupilumab

Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo