Alicaforsen

Alicaforsen

A randomised, double-blind, placebo controlled trial of the safety and efficacy of topical Alicaforsen enema in active, chronic, antibiotic-refractory primary idiopathic pouchitis.

 

Inclusion criteria:

  • Active disease
    • ≥6 stools/day OR ≥3 stools above post-IPPA baseline
    • PDAI score ≥7
    • Endoscopic score ≥2
  • Chronicity, i.e. symptomatic for at least 4 weeks continuously prior to randomisation
  • Antibiotic refractory, i.e. active disease despite 2 week course of antibiotics (must be stopped at least 4 weeks before randomisation)

 

Exclusion Criteria:

  • History of faecal transplant
  • Cuffitis (patients with both pouchitis and cuffitis may be enrolled)
  • Crohn’s Disease of the pouch defined as
    • Complex perianal/pouch fistula and/or
    • Extensive pre-pouch ileitis with deep ulceration

 

Medications:

 

Permitted Not Permitted
  • Oral 5-ASA (Stable dose for 4 weeks prior to screening)
  • Oral corticosteroids ≤15mg/day
  • (Stable for 4 weeks prior)
  • Azathioprine, methotrexate or 6-MP
  • (Stable for 8 weeks prior)
  • Oral budesonide ≤6mg/day
  • (stable for 4 weeks)
  • VSL3 (Stable for 4 weeks prior)
  • Rectal formulations of 5-ASA or corticosteroids in the 8 weeks prior to screening
  • Antibiotics in the 2 weeks before screening
  • Opioids must be stopped at screening

*Previous alicaforsen use is permitted but course must have been completed at least 12 weeks prior to screening.*

 

If you are interested in participating in this study either as a patient or an investigator, please contact initiativeibd@gmail.com