Request for EoE Study Referrals
Eosinophilic Esophagitis (EoE) dupilumab trial(R668-EE-1774)
Contact Study Coordinator: Jessica Barlas email@example.com or call 212-686-6321
DBPC study of adolescent and adults with EoE x 6 months followed by open label dupilumab treatment x 6 months. Principal investigator: Robert Y Lin MD, Co-investigators Hon-Ming Eng MD & Morris Nejat MD
Key inclusion criteria:
∙ History of Dysphagia: An average of at least 2 episodes of dysphagia per week in the 4 weeks prior to screening.
* EoE endoscopically diagnosed (>15/HPF) any time in the past after 8 weeks high-dose PPI treatment(eg omeprazole 40 mg/d or equivalent).
* Biopsy could have been within 2 weeks of 8 week PPI treatment course if stopped.
Key exclusion criteria:
* Swallowed steroid treatment in the prior 8 weeks
* Any prior dupilumab
* Use of immunomodulatory/biologic drugs in the prior 3 months
* Any serious systemic, malignant or other serious GI diseases
* Changed inhaled or nasal steroids or leukotriene modifier drugs or allergy shots in the prior 8 weeks (can be on stable doses).
Intervention: weekly injections of dupilumab or placebo. Patients will be screened for requisite dysphagia frequency and baseline endoscopy showing EoE before randomization.
Evaluations: baseline & interval labs/questionnaires, endoscopy at screening, 6 m and 12 m, visits every 1-4 weeks(more in the beginning less at the end)
Reimbursements: ~$50 per visit, endoscopy visits ~$250