Request for Study Referrals

Self-initiated study that is IRB approved(NYMC).

The study is "Sublingual dust mite immunotherapy as a modality for ameliorating hypersensitivity reactions during rush immunotherapy". Patients with rhinitis control assessment test score<18 and prick skin test for DF/DP of at least 5 mm, and who consent will be treated with prescribed Odactra for 3 months and then undergo 2 rush immunotherapy sessions 1 week apart followed by maintenance DF/DP SCIT treatment 4 weeks later. The endpoint will be whether they can tolerate the rush immunotherapy(RIT) and SCIT maintenance initiation without anaphylaxis. Patients referred can follow up their subsequent SCIT with the referring practice/MD.

Robert Y Lin, MD

New York Allergy and Sinus Centers

contact email: drlin@robertylinmd.com

contact phone: 917-740-6011

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