PENGUIN 1

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naïve to Biologic DMARD Therapy

• IRAS ID

  269896

• Contact name

  Helena Marzo-Ortega

• Contact email

  h.marzo-ortega@leeds.ac.uk

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2019-001996-35

• Clinicaltrials.gov Identifier

  NCT04115748

• Clinicaltrials.gov Identifier

  115510, IND Number

• Duration of Study in the UK

  3 years, 7 months, 20 days

• Research summary

  This study, sponsored by Gilead Sciences Inc, will test an experimental drug named filgotinib for the treatment of psoriatic arthritis (PsA). PsA is a disease where the body’s immune system attacks its own joints causing joint pain, swelling and skin inflammation or lesions. PsA occurs in approximately 30% of psoriasis patients. In most cases, (75%), psoriasis precedes joint disease, but in some cases (15%) the onset of PsA happens at the same time as the psoriasis and in 10% arthritis precedes psoriasis. First-line treatment traditionally consists of anti-inflammatory medication (to manage the swelling caused) and disease-modifying antirheumatic drugs (to slow down the progression of arthritis). Adalimumab is also used to treat PsA and does so by supressing the immune system. Tofacitinib is also used to treat PsA by inhibiting the Janus kinases (JAK) enzymes but has therapeutic limitations due to side effects. Because filgotinib is a more targeted therapy it has potential for the treatment of PsA with an improved safety and side effect profile.
  This will be a randomised study where patients will, by chance, initially receive either a placebo (a dummy drug with no active ingredients), adalimumab (comparator drug), 200mg filgotinib or 100mg filgotinib. Patients will be randomised to one of the above 4 treatment groups on 2:2:1:2 basis. The main study part of the study will last for 24 weeks with an extension study to 2 years during which patients still receiving placebo or adalimumab will be randomised to receive either 100mg or 200 mg Filogotinib on a 1:1 basis.
  Globally the study will recruit 1001 participants at approximately 227 sites. 38 patients are planned in the UK over 15 sites.
  Study assessments include but are not limited to:
  1) Demographics, Medical History, Physical Examinations
  2) Patient Reported Outcomes
  3) Physician reported measurements
  4) Safety Assessments

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  20/EM/0063

• Date of REC Opinion

  23 Apr 2020

• REC opinion

  Further Information Favourable Opinion