ANB019-002: ANB019 in Subjects with Generalized Pustular Psoriasis

• Research type

  Research Study

• Full title

  A Single Arm Multiple Dose Study to Assess the Efficacy and Safety of ANB019 in Subjects with Generalized Pustular Psoriasis

• IRAS ID

  240858

• Contact name

  Andrew Pink

• Contact email

  andrew.pink@kcl.ac.uk

• Sponsor organisation

  AnaptysBio Inc.

• Eudract number

  2017-004021-33

• Clinicaltrials.gov Identifier

  136145, Investigational New Drug number

• Duration of Study in the UK

  1 years, 1 months, 2 days

• Research summary

  This is an open-label, single arm, multiple dose study to assess the efficacy (how well the drug works), safety, tolerability and PK (pharmacokinetics) of ANB019 (the study drug) in patients with Generalised Pustular Psoriasis (GPP). GPP is a severe, debilitating, and life-threatening systemic inflammatory disease.
  The study will have a screening period of 7-28 days, treatment period of 12 weeks, and follow-up period of 12 weeks. Patients will receive the study drug, ANB019 on Day 1 intravenously (IV or through a vein) followed by 3 doses of ANB019 given subcutaneously (SC or under the skin) on Days 29, 57, and 85.
  Approximately 10 patients will be enrolled in the study in the UK. The sponsor is AnaptysBio.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  18/LO/0319

• Date of REC Opinion

  4 May 2018

• REC opinion

  Further Information Favourable Opinion