SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis

• Research type

  Research Study

• Full title

  Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis)

• IRAS ID

  74032

• Contact name

  David Jayne

• Sponsor organisation

  Nordic Pharma SAS

• Eudract number

  2011-001219-30

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is to compare Gusperimus with conventional therapy in patients with Wegener??s granulomatosis (WG), also known as Granulomatosis with polyangitis (GPA). 216 patients will be enrolled total; 50 from the UK. Patients will be stratified into two groups (severe and non-severe relapses) using a scoring method; the Birmingham Vasculitis Assessment Scale (BVAS). Participants will be randomly allocated to treatment with Gusperimus and Glucocorticoid (GC) (Test Group) or active control treatments (Control group). The Test Group will include both severity subgroups. Gusperimus will be dosed at 0.5mg/kg daily and will require reconstitution and administration by subcutaneous injections by the participant (or third person) in 28 day cycles (every 4 weeks throughout the study): 21 day treatment period / 7day resting period. Should the white blood count (WBC) fall below 4000/mm3 whilst on treatment, the subsequent cycles will be shortened by two days. After 16 weeks of treatment the GC dose will be reduced in a step wise fashion. The control group (severe subgroup) will receive: intravenous Cyclophosphamide (CYC) pulses for at least 13 weeks (22 weeks maximum), followed by Methotrexate (MTX) GC after achieving a response with BVAS = 2. Participants intolerant to MTX and patients with impaired renal function (eGFR = 60 mL/min/1.73 m2) will receive Aziathioprine (AZA) GC. The control group (non-severe) subgroup will receive MTX GC (or AZA GC for those intolerant / with impaired renal function as above). All patients will have monthly visits up to and including Visit 7, after which visits are spaced at 6, 8 and 13 weeks apart, visits 8, 9, 10 respectively. The End of Study visit will be 4 weeks after the last trial medication (week 56). Participant safety will be monitored throughout the study via analysis of bloods samples taken at each visit, alongside physical examinations.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0361

• Date of REC Opinion

  8 Nov 2011

• REC opinion

  Further Information Favourable Opinion