Penguin 2

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Have an Inadequate Response or are Intolerant to Biologic DMARD Therapy

• IRAS ID

  271345

• Contact name

  Laura Coates

• Contact email

  laura.coates@ndorms.ox.ac.uk

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2019-002021-29

• Clinicaltrials.gov Identifier

  NCT04115839

• Clinicaltrials.gov Identifier

  IND, 115510

• Duration of Study in the UK

  3 years, 5 months, 11 days

• Research summary

  Objectives: to evaluate the effect of the study drug; filgotinib, compared to placebo on the signs and symptoms, physical function, quality of life, and preservation of joint structure in patients with Psoriatic Arthritis (PsA) who have an Inadequate Response or are Intolerant to Biologic Disease-modifying anti-rheumatic drug Therapy). The safety and tolerability of filgotinib will also be assessed. The sponsor is Gilead Sciences, Inc.

  PsA is a disease associated with psoriasis, joint stiffness, pain, inflammation of the connective tissue, swollen fingers and toes, fatigue and affects people who already have psoriasis.

  Options for the treatment of PsA have increased dramatically. Despite significant uptake in the use of anti-TNF agents, tolerability due to allergic and autoimmune reactions, loss of response due to immunogenicity and increased risk of infections remain problematic.

  The study drug Filgotinib is a potent and highly selective JAK1 inhibitor drug that has been tested in humans previously and generally proven safe and well tolerated.
  Data from previous studies supports further development: The filogotinib group compared to placebo achieved a statistically significantly higher percentage of ACR20 responders, demonstrated significantly higher clinical efficacy with additional PsA assessments and achieved skin and Patient Reported Outcome improvements.

  The study consists of the Main Study (16weeks) and the Long Term Extension (2years)

  Approximately 390 subjects globally will be randomized in a 1:1:1 ratio to one of 3 dosing groups

  After completion of the Main Study, subjects who have not discontinued will continue to the LTE. Those assigned to the filgotinib groups will continue on the same assignments. Those assigned to the placebo group will be reassigned 1:1 in a blinded fashion to filgotinib 200mg or 100mg

  Study assessments include but are not limited to:

  1) Demographics, Medical History, Physical Exams

  2) Patient Reported Outcomes

  3) Physician reported measurements

  4) Safety Assessments
  Vital Signs, Weight, 12-lead Electrocardiogram, Pregnancy, Haematology, serum chemistry, urinalysis and Tuberculosis Testing

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  20/SC/0022

• Date of REC Opinion

  4 May 2020

• REC opinion

  Further Information Favourable Opinion