Study M16-067 comprises two sub-studies:1) The objective of Sub-Study 1 are to characterize the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC) and…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of subjects with clinical remission per Adapted Mayo score at Week
12.
Secondary outcome
Sub Study 1
1. Percentage of Subjects with Endoscopic Improvement at Week 12
2. Percentage of Subjects Achieving Clinical Remission at Week 12 in Subjects
with a Full Mayo Score of 6 to 12 at Baseline
3. Percentage of Subjects Achieving Clinical Response at Week 12
4. Percentage of Subjects Achieving Clinical Response at Week 4
5. Percentage of Subjects in Endoscopic Remission at Week 12
6. Percentage of Subjects with Hospitalizations through Week 12
7. Percentage of Subjects Achieving histologic endoscopic mucosal remission
(HEMR) at Week 12
8. Change from Baseline in 'UC-Symptom Questionnaire (UC-SQ)' at week 12
9. Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ)
at Week 12
10. Change from Baseline in Short Form-36 at Week 12
11. Change from Baseline in Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT Fatigue)' at Week 12
12. Percentage of Subjects with UC-Related Surgery Through Week 12
Sub study 2
1. Percentage of Subjects Achieving Clinical Response at Week 12 by Adapted
Mayo Score
2. Percentage of Subjects with Endoscopic Improvement at Week 12
3. Percentage of Subjects Achieving histologic endoscopic mucosal improvement
(HEMI) at Week 12
4. Percentage of Subjects with Endoscopic Remission at Week 12
5. Percentage of Subjects Achieving Clinical Response at Week 4 by Partial
Adapted Mayo Score
6. Percentage of Subjects Reporting No Bowel Urgency at Week 12
7. Percentage of Subjects Reporting No Abdominal Pain at Week 12
8. Percentage of Subjects Achieving histologic endoscopic mucosal remission
(HEMR) at Week 12
9. Change from Baseline in Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT Fatigue) at Week 12
10. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at
Week 12
11. Percentage of Subjects with UC-Related hospitalizations through Week 12
12. Percentage of subjects who reported no nocturnal bowel movements at week 12
13. Percentage of subjects who did not report tenesmus at week 12
14. Change from Baseline in Number of Fecal Incontinence Episodes per Week at
Week 12
15. Change from Baseline in Number of Days Per Week During Sleep Interruption
Due to UC Symptoms at Week 12
Background summary
UC is a chronic, relapsing inflammatory disease of the large intestine
characterized by inflammation and ulceration of mainly the mucosal and
occasionally submucosal intestinal layers. The clinical course is marked by
exacerbation and remission.
The aim of medical treatment in UC is to control inflammation and reduce
symptoms. Available pharmaceutical therapies are limited, do not always
completely abate the inflammatory process, and may have significant adverse
effects. Thus, there remains a clear medical need for additional therapeutic
options in UC for patients with inadequate response to or intolerance to
conventional therapies and biologic therapies
Study objective
Study M16-067 comprises two sub-studies:
1) The objective of Sub-Study 1 are to characterize the efficacy, safety, and
pharmacokinetics of risankizumab as induction treatment in subjects with
moderately to severely active ulcerative colitis (UC) and to identify the
appropriate induction dose of risankizumab for further evaluation in Sub-Study
2.
2) The objective of Sub-Study 2 is to evaluate the efficacy and safety of
risankizumab compared to placebo in inducing clinical remission in subjects
with moderately to severely active UC
Study design
This is a Phase 2b/3, multicenter, randomized, double-blind, placebo-controlled
study designed to evaluate the efficacy and safety of risankizumab as induction
therapy in adult subjects with moderately to severely active UC.
Intervention
Subjects receive risankizumab or placebo, via IV, during the 12 week induction
period (weeks 0 to 12); subjects with inadequate response receive risankizumab,
via IV or SC, during the 12 week induction period 2 (week 12 to 24).
Study burden and risks
There will be higher burden for subjects participating in this trial compared
to their standard of care. Subjects will be visiting the hospital more
frequently. During these visits study procedures will be performed including
blood sampling and filling in questionnaires. Subjects will also be tested for
TB, significant heart conditions, pregnancy, HCV/HBV and HIV. Subjects will
also complete a daily diary. Women of Childbearing Potential should practice a
method of birth control, during the study through at least 140 days after the
last dose of study drug.
Subjects will either receive risankizumab and/or placebo during the study. The
most common side effects reported during previous studies of risankizumab were
nausea, abdominal pain, joint pain and headache.
The hypothesis that risankizumab should be effective in treating inflammation
in patients with ulcerative colitis who are unable to tolerate or who have had
an insufficient response to treatment with some currently available
medications, indicates that there is an acceptable rationale to conduct this
study. The risks and burden associated with participating in this study are
acceptable in regards to the potential benefit study subjects could possibly
have.
Wegalaan 9
Hoofddorp 2132 JD
NL
Wegalaan 9
Hoofddorp 2132 JD
NL
Listed location countries
Age
Inclusion criteria
- Male or female aged >= 18 to <= 80 years, or minimum age of adult consent
according to local regulations at the Baseline Visit. In addition for sub-study
2 only: Where locally permissible, subjects 16 to < 18 years of age who meet
the definition of Tanner stage 5 for development at the Baseline Visit
- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to
Baseline.
- Active UC.
- Demonstrated intolerance or inadequate response to one or more of then
following categories of drugs: aminosalicylates, oral locally acting sterioids,
systemic steroids, immunomodulators, and/or biologic therapies
Exclusion criteria
- Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel
disease-unclassified (IBD-U) or a history of radiation or ischemic colitis.
- Subject receiving prohibited medications and treatment.
- Extent of inflammatory disease limited to the rectum as assessed by screening
endoscopy.
- Subject with currently known complications of UC.
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 |
|---|---|
| EudraCT | EUCTR2016-004677-40-NL |
| ClinicalTrials.gov | NCT03398148 |
| CCMO | NL63855.018.18 |