(ISN) 6294-CL-0101_The SERENITY study

• Research type

  Research Study

• Full title

  A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis

• IRAS ID

  227321

• Contact name

  Robert Freeman

• Contact email

  robert.freeman@nhs.net

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2016-004138-12

• Duration of Study in the UK

  1 years, 6 months, 22 days

• Research summary

  Bladder pain syndrome/interstitial cystitis (BPS/IC) is a chronic pain (pressure or discomfort) related to bladder filling. The pelvic pain associated with this is usually accompanied by one or more lower urinary tract symptoms. This condition affects 45 to 197 per 100,000 women. Management of the disease is based on treatment of the symptoms mainly focuses on pain relief. Given the high prevalence of the disease, the high burden and the lack of effective treatment, it is clear that this disease has a high unmet medical need.

  Nerve growth factor (NGF) blockade may provide a potential therapeutic option for BPS/IC. NGF levels in tissue are substantially increased following tissue damage, in inflammation, or in chronic pain states. ASP6294, developed by Astellas, has demonstrated potent NGF neutralising activity. This anti-NGF antibody was shown to be effective in animal models for pain.

  This study will look at the effects of ASP6294 in female participants with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) and investigate safety and tolerability of the drug.

  The study consists of the following:

  Screening to determine if the participant is eligible
  Eligible participants will enter a 2-week run-in period monitoring their pain levels

  12-week double-blind treatment period – participants will receive either the study drug ASP6294 or an identical placebo via injections during 3 study visits and also undergo further study procedures and tests. All visits will take place in the morning.

  6-week follow-up period followed by an end of study visit

  This study involves procedures such as – Ultrasound, blood tests, ECGs, urine tests, questionnaires and diary completion

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  17/EM/0295

• Date of REC Opinion

  30 Oct 2017

• REC opinion

  Further Information Favourable Opinion