CAIN457R12301

• Research type

  Research Study

• Full title

  A randomized, parallel-group, double-blind, placebo-controlled,multicenter Phase III trial to investigate theefficacy and safety of secukinumab 300 mg administeredsubcutaneously versus placebo, in combination with aglucocorticoid taper regimen, in patients with giant cellarteritis (GCA)

• IRAS ID

  1003718

• Contact name

  Neila Benabadji

• Contact email

  neila.benabadji@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2020-004809-31

• Research summary

  The purpose of the study is to demonstrate safety and efficacacy of secukinumab (300 mg administered by a subcutaneous (under the skin) injection) for 52 weeks in combination with a steroid dose which is tapered over 26 weeks in adults with newly diagnosed or relapsing giant cell artheritis (GCA).
  In GCA the arteries, particularly those at the side of the head become inflammed resulting in frequent, severe headaches, jaw pain and visual problems. Current treatment is with steroids, a high dose for a few weeks then a lower dose these patients relapse once the treatment is reduced or stopped.
  The trial is a phase III study involving 240 participants; males or females at least 50 years of age with new-onset or relapsing GCA. Patients will be randomised to one of two treatment arms in a 2:1 ratio. Group 1 will receive secukinumab in combination a 26 week prednisone taper regimen and group 2 will receive placebo in combination with a 52 week prednisone taper regimen. Secukinumab has already demonstrated a positive risk/benefit ratio in the treatment of multiple chronic inflammatory diseases.
  The study will consist of a screening period, a 56-week treatment period, a second 52 week treatment period and an 8 week safety follow up period. Initially patients will be seen once a week then after 4 weeks they will have 4 weekly assessments. Patients will complete health questionnaires and have regular blood tests. The success of the study will be measured by the primary outcome which is sustained remission at week 52, where patient have no signs or symptoms of GCA and have no elevated levels of inflammatory markers in their blood. the study team will also look at the effect on the patients' quality of life using the health questionnaires completed throughout the study.
  Patients who are initially randomised to placebo and who do not achieve clinical remission will be offered open label secukinumab at the end of treatment period

• REC name

  Wales REC 1

• REC reference

  21/WA/0237

• Date of REC Opinion

  27 Aug 2021

• REC opinion

  Further Information Favourable Opinion