STUDY SUMMARY:
PAEDS
OVERVIEW
Results from a multi-centre, investigator-initiated, randomised controlled, investigator-blinded induction of remission trial 1
6 week study, 83 patients (ITT), dosing based on weight (75 mg/kg/day)
Patient Numbers
Weight
Dose Amount
Dose Frequency
40
15–>20 kg
1,000 mg (500 mg, 500 mg)
Twice-daily
20–>30 kg
1,500 mg (1,000 mg, 500 mg)
30–>40 kg
2,000 mg (1,000 mg, 1,000 mg)
≥40 kg
3,000 mg (1,500 mg, 1,500 mg)
INCLUSION AND EXCLUSION CRITERIA 1
Key Inclusion Criteria:
- Children 4-18 years of age* with body weight ≥15kg
- Confirmed diagnosis of UC in mild to moderate disease activity according to PUCAI
Key Exclusion Criteria:
- Proctitis only, IBD unclassified, current systemic infection, presence of stool pathogens at screening (culture, parasites and Clostridium difficile) and significant concurrent illness (e.g. renal and hepatic failure or pancreatitis)
SAFETY RESULTS 1
- 23% of patients (n=9/40) in the BD group had an adverse event
- The most common adverse events in the BD group were:
– Disease exacerbation (3 total)
– Headache (2 total)
– Fever (2 total)
– Nausea (2 total) - None of the SAEs were thought to be related to the study drug
