CODY UK Amendment#1 dated 21.07.2021

• Research type

  Research Study

• Full title

  A multicenter, Phase 2b, randomized, doulble-blind, stratified, vehicle controlled study evaluating the safety and efficacy of Sirolimus 3.9% topical gel in prevention of BCCS in patients with Gorlin Syndrome

• IRAS ID

  301722

• Contact name

  John Lear

• Contact email

  john.lear@srft.nhs.uk

• Sponsor organisation

  Palvella Therapeutics, Inc

• Eudract number

  2021-003148-25

• Clinicaltrials.gov Identifier

  NCT04893486

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 4 months, 2 days

• Research summary

  Patients with Gorlin Syndrome often develop Basal Cell Carcinomas. This study is to determine if a new drug containing Sirolimus, may help to prevent the develpment of Basal Cell Carcinoma in patients with Gorlin Syndrome.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  21/NW/0300

• Date of REC Opinion

  15 Dec 2021

• REC opinion

  Further Information Favourable Opinion