LLE1002

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome)

• IRAS ID

  280107

• Contact name

  Catherine Anne Harwood

• Contact email

  catherine.harwood1@nhs.net

• Sponsor organisation

  PellePharm, Inc.

• Eudract number

  2020-000253-27

• Duration of Study in the UK

  1 years, 9 months, 19 days

• Research summary

  PellePharm is developing a topical formulation of patidegib for the management of the disease burden of persistently developing basal cell carcinomas in patients with Gorlin syndrome and a high frequency of basal cell carcinomas (HF-BCC). To date, there are currently no approved therapies for Gorlin syndrome or HF-BCC. It is hoped that, by decreasing the number of surgeries that these patients require, their quality of life will be greatly improved.

  This is a global, multicentre, open label extension study offered to patients with Gorlin syndrome who have previously participated in studies 926-201 or 926-301. The objective of this study is to test how effective and safe the Patidegib Topical Gel 2% is on an ongoing basis.

  About 200 participants will take part in this study. The treatment duration is 12 months, with potential extension beyond this period.
  

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  20/LO/0547

• Date of REC Opinion

  5 Jun 2020

• REC opinion

  Further Information Favourable Opinion