* 1368-0059 Spesolimab in Crohn's Disease
Research type
Research Study
Full title
Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease
IRAS ID
296487
Contact name
Christian Selinger
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2020-005770-99
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 25 days
Research summary
This PoCC study is a phase II study to determine whether one active dosage of 1200mg of Spesolimab (BI 655130) is effective in the treatment of participants with fibrostenotic Crohn’s Disease, as well as to start the development and validation processes of a new tool to measure clinical and structural outcomes in these participants.
The population will include male and female participants aged 18 and over with a diagnosis of Fibrostenotic Crohn’s Disease at least 3 months prior to screening. Participants who have failed at least 2 different biological drug classes prior to screening will be excluded from the study.
Participants will be consented at visit 1 and will follow a 12 week lead-in period where they will be treated for two weeks with corticosteroids which will be slowly tapered according to a standardised 8 week regimen; followed by at least 8 weeks where optimization of the anti-inflammatory biological treatment is achieved. Participants will then be treated for a total of 48 weeks with a dose of 1200mg administered every 4 weeks until week 8, followed by 1200mg every 8 weeks until the last administration at week 40. Participants will continue to receive their biologic treatment throughout the duration of the treatment period.
At end of the treatment period, participants who are showing benefit will be offered participation in a long-term extension study, all other participants will complete their end of study visit 8 weeks after final treatment.
As this is a placebo-controlled trial, some participants will receive a non-active substance at the same dosing timepoints as above; each eligible participant will be randomised to treatment groups according to a randomisation plan in a 1:1 ratio at Visit 3.REC name
London - South East Research Ethics Committee
REC reference
21/FT/0112
Date of REC Opinion
11 Oct 2021
REC opinion
Further Information Favourable Opinion