This study has been transitioned to CTIS with ID 2022-501645-70-00 check the CTIS register for the current data. Part 1:The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1:
1. Clinical remission (non-inferiority) at week 24: CDAI < 150
2 . Endoscopic remission (superiority) at week 48: defined as Simple Endoscopic
Score for Crohn's Disease (SES-CD) <= 4 and at least a 2-point
reduction versus Baseline and no sub score greater than 1 in any individual
variable, as scored by a central reviewer.
Part 2:
1. Evaluation of long-term safety
Secondary outcome
1. Achievement of clinical remission (CDA < 150) at Week 48: superiority of
risankizumab vs. ustekinumab.
2. Achievement of endoscopic response at Week 48, superiority of risankizumab
vs. ustekinumab.
3. Achievement of endoscopic response at Week 24, superiority of risankizumab
vs. ustekinumab.
4. Achievement of steroid-free endoscopic remission Week 48, superiority of
risankizumab vs. ustekinumab.
5. Achievement of steroid-free clinical remission at Week 48, superiority of
risankizumab vs. ustekinumab.
Background summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can
affect any part of the gut. This study will evaluate how well risankizumab
works compared to ustekinumab. This study will assess change in Crohn's Disease
Activity Index (CDAI).
Study objective
This study has been transitioned to CTIS with ID 2022-501645-70-00 check the CTIS register for the current data.
Part 1:
The objective is to compare the efficacy and safety of risankizumab versus
ustekinumab over 48 weeks for the treatment of adult subjects with moderate to
severe Crohn's Disease (CD) who have failed anti-TNF therapy.
Part 2:
The objective is to evaluate the long-term safety of risankizumab up to 220
weeks in subjects who received risankizumab during Part 1 and have completed
the Week 48 visit.
Study design
Randomized, efficacy assessor-blinded, parallel group study.
Intervention
In Part 1, participants assigned to risankizumab will receive intravenous (IV)
doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks
thereafter through Week 48. Participants assigned to ustekinumab will receive
intravenous (IV) dose of ustekinumab at Week 0 and
subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2,
participants who received risankizumab in Part 1 and completed the Week 48
visit will continue to receive SC risankizumab for up to an additional 220
weeks.
Study burden and risks
There may be higher treatment burden for participants in this trial compared to
their standard of care. Participants will attend regular visits during the
study at a hospital or clinic. The effect of the treatment will be checked by
medical assessments, blood tests, checking for side effects and completing
questionnaires.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
- Male or female aged >= 18 to <= 80 years of age at the Baseline visit.
- Confirmed diagnosis of Crohns disease (CD) for at least 3 months prior to
Baseline.
- Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
- Confirmed diagnosis of moderate to severe Crohns Disease as assessed by stool
frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD
(SES-CD).
- Demonstrated intolerance or inadequate response to one or more anti-TNF
therapies
- If female, subject must meet the contraception recommendations
Exclusion criteria
- Subject with a current diagnosis of ulcerative colitis or indeterminate
colitis.
- Subjects with unstable doses of concomitant CD therapy
- Receipt of CD approved biologic agents prior to baseline (as detailed in
protocol), or any investigational - biologic or other agent or procedure prior
to Baseline (as detailed in protocol)
- Subject with prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab
and ustekinumab).
- Subject with complications of CD (strictures, short bowel, etc)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2022-501645-70-00 |
| EudraCT | EUCTR2020-002674-26-NL |
| ClinicalTrials.gov | NCT04524611 |
| CCMO | NL74847.056.20 |