Request for EoE Study Referrals

Eosinophilic Esophagitis (EoE) dupilumab trial(R668-EE-1774)

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

Contact Study Coordinator: Jessica Barlas jessbarlas@nyallergy.com

or call 212-686-6321

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