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

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Regeneron Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Eosinophilic Esophagitis

Treatments

Drug: Dupilumab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03633617
2018-000844-25 (EudraCT Number)
R668-EE-1774

Details and patient eligibility

About

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 To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids

Enrollment

321 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria (Parts A & B):

  • A documented diagnosis of EoE by endoscopic biopsy
  • Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
  • 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):

  • Body weight ≤40 kg
  • Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
  • 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.
  • Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
  • Active Helicobacter pylori infection
  • History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
  • 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
  • History of bleeding disorders or esophageal varices
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Key Exclusion Criteria (Part C):

  • 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
  • Participants who became pregnant during Part A or Part B
  • 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)
  • Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment

Note: Other inclusion/ exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

321 participants in 3 patient groups

Part A: Dupilumab or Placebo
Experimental group
Description:
Part A consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Treatment:
Drug: Placebo
Drug: Dupilumab
Part B: Dupilumab or Placebo
Experimental group
Description:
Part B consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab dosing regimen 1, dupilumab dosing regimen 2 or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Treatment:
Drug: Placebo
Drug: Dupilumab
Part C: Dupilumab
Experimental group
Description:
Part C is a 28-week extended active treatment period. Participants will receive dupilumab dosing regimen 1, dupilumab dosing regimen 2. At the end of the treatment period (week 52), participants will enter a 12-week follow-up period.
Treatment:
Drug: Dupilumab

Trial documents
3

Trial contacts and locations

95

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Data sourced from clinicaltrials.gov

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