- Title: Efficacy and safety of Risankizumab, a p19-selective IL-23 inhibitor, Compared to Ustekinumab in moderate to severe CD - Who Have Failed Anti-TNF therapy
- Study drug: Risankizumab
- Sponsor: AbbVie
- Participating centers and contact: Insel Bern, PD Dr. med. Pascal Juillerat (Pascal.Juillerat@insel.ch)
- Target population: Moderate to severe CD
- Primary outcome:
- 1. Sub-Study 1 and Sub-Study 2: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 52 ]
- The CDAI is used to evaluate disease activity in patients with Crohn's disease. The CDAI clinical remission is defined as a CDAI score of < 150.
- 2. Sub-Study 1 and Sub-Study 2: Percentage of Participants With Endoscopic Response [ Time Frame: Week 52 ]
- Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn's Disease (SES-CD).
- 3. Sub-Study 3: Number of Participants With Adverse Events [ Time Frame: Up to Week 220 ]
- An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
- Inclusion Criteria:
- Participants who have entered and completed Study M16-006 or Study M15-991 or Study M15-989.
- Participants have completed the study M16-006 or M15-991 and have achieved clinical response.
- Exclusion Criteria:
- Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .
- Participant who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of Chinese hamster ovary (CHO), OR had an adverse event (AE) during Studies M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the participant unsuitable for this study.
- Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989.
- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989.
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.
- More information: https://www.clinicaltrials.gov/ct2/show/NCT03105102?term=Risankizumab&cntry=CH&draw=2&rank=3