POWER - Patient Optimization With ustEkinumab Re-induction
Research type
Research Study
Full title
A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease.
IRAS ID
271444
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen Cilag-International NV
Eudract number
2018-002629-51
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
This is a global study with a target population consisting of subjects with moderately-to-severely active Crohns disease of at least 6 months duration who have had a demonstrable and documented response to initial induction with ustekinumab before experiencing loss of response, through standard of care. It is these subjects who have a loss of response who are then considered for the POWER study.
A target of 200 subjects will be enrolled, where eligible subjects will be randomized in a 1:1 ratio to Intravenous 're-induction' versus regular subcutaneous injection at week 0. The trials participants will then receive subcutaneous injection at week 8 and Week 16 and then move back into standard of care at week 24 should the participant show response/remission.
Other study assessments include CDAI and video ileocolonoscopy; patient reported outcomes; laboratory evaluations; physical examinations; vital signs measurements; review of concomitant medications and adverse events (AEs); and evaluation of serum concentrations of study agent and antibodies to study agent.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0155
Date of REC Opinion
16 Mar 2020
REC opinion
Further Information Favourable Opinion