M16-852 GCA

• Research type

  Research Study

• Full title

  Protocol M16-852: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis

• IRAS ID

  257278

• Contact name

  Ernest Wong

• Contact email

  Ernest.Wong@porthosp.nhs.uk

• Sponsor organisation

  AbbVie Ltd

• Eudract number

  2017-003978-13

• Clinicaltrials.gov Identifier

  NCT03725202

• Duration of Study in the UK

  3 years, 2 months, 1 days

• Research summary

  Giant cell arteritis (GCA), also known as temporal arteritis, is a chronic inflammatory disease of blood vessels, most commonly in the head and neck area.

  Corticosteroid therapy (CS) remains the mainstay treatment for GCA. Despite relieving many of the symptoms prolonged exposure to CS therapy can cause unwanted side effects and the underlying inflammation may still persist in some patients. Thus, there remains the potential for improved treatments.

  Upadacitinib is an investigational drug currently being developed for the treatment of adult patients with inflammatory diseases such as GCA. This study will evaluate how well upadacitinib in combination with CS works within the body and how safe it is compared to placebo (an inactive substance) for the treatment of adult patients with GCA who are at least 50 years old. The CS dosage will gradually be reduced over the course of the study, this is known as tapering. Around 420 participants at approximately 140 sites worldwide will be included.

  The study is split into two periods. In period 1, study subjects will be randomly assigned to receive one of the following treatment regimens over a period of 52 weeks:
  • Upadacitinib Dose A oral tablet once daily + 26 week CS taper regimen
  • Upadacitnib Dose B oral tablet once daily + 26 week CS taper regimen
  • Placebo oral tablet once daily + 52 week CS taper regimen

  Participants that do not have any signs or symptoms of GCA at the end of period 1 will continue to period 2 and will receive upadacitinib or placebo for a further 52 weeks.

  The study is blinded meaning neither the participant nor the study Doctor will know what treatment regimen has been assigned.

  Participation could last up to 113 weeks in total. Patients will have approximately 20 study visits to the research centre.

• REC name

  London - South East Research Ethics Committee

• REC reference

  19/LO/1120

• Date of REC Opinion

  5 Sep 2019

• REC opinion

  Further Information Favourable Opinion