A study to test whether BI 706321 combined with ustekinumab helps people with Crohn’s Disease
Research type
Research Study
Full title
A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment
IRAS ID
1007787
Contact name
Esha Dasgupta
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Eudract number
2020-004527-16
Research summary
The investigational study drug, BI 706321 is being developed to see if it can improve the symptoms of Crohn’s disease (CD) when taken with ustekinumab. The main objectives of this trial are to investigate a first signal of efficacy, safety and tolerability of BI 706321 in combination with ustekinumab treatment compared to placebo with ustekinumab treatment in patients with moderately to severely active CD at 12 weeks. Participation will last approximately 48 weeks. This double-blind trial compares the effects of the active study drug BI 706321 with an inactive substance, placebo. The participant will be assigned randomly to receive either BI 706321 or placebo and will have an equal chance (50% chance to get the one or the other) of being placed in one of the following groups: 8 mg of BI 706321 (3 tablets) once a day, for 12 weeks or Placebo matching 8 mg of BI 706321 (3 tablets) once a day, for 12 weeks. Every participant will get at the same time ustekinumab for 48 weeks, the locally approved dose will be administered. Before the trial starts, there will be a screening visit to confirm the participant’s eligibility which will include the screening visit procedures as specified in the protocol. Blood, Urine, Stool samples will be tested to observe any laboratory abnormalities. If the assessments confirm the participant’s eligibility, an ileo-colonoscopy will be performed to additionally confirm the disease activity. During that assessment biopsies will be taken for further analysis. There will be clinical trial procedures including Physical Examination, Blood tests, urinalysis, Electrocardiogram, Endoscopy etc. as outlined in the protocol, during the study. If a participant is interested to take part in the study, the consent forms will be required to be signed. The data obtained over the first 12 weeks will determine whether BI 706321 increases the efficacy of ustekinumab, and the 48 week data will be used to investigate safety and and long term efficacy.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0399
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion