Brief description of trial (Data source: BASEC)
Morbus Crohn (MC) ist eine lang anhaltende, entzündliche Erkrankung von verschiedenen Darmabschnitten. MC kann Müdigkeit, Durchfall (mit oder ohne Blut im Stuhl), Bauchschmerzen, Gewichtsabnahme und Fieber verursachen.
Risankizumab ist ein Studienmedikament, das zur Behandlung entzündlicher Erkrankungen entwickelt wurde. Alle Patienten mit MC, welche die Studie M15-991 oder M16-006 abgeschlossen und auf die Behandlung angesprochen haben, kommen gegebenenfalls für eine Teilnahme an dieser Studie infrage.
Health conditions investigated(Data source: BASEC)
Morbus Crohn (MC)
Health conditions
(Data source: WHO)
Crohn's Disease
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Die Studie besteht aus 3 Teilen und etwa 912 Patienten mit MC werden weltweit an dieser Studie teilnehmen.
Teilstudie 1 dauert 52 Wochen, wobei die Wirksamkeit und Sicherheit von Risankizumab im Vergleich zu Placebo (Medikament ohne Wirkstoff) untersucht wird und ob sich die Symptome des MC weiter reduzieren. Etwa 450 Patienten, welche auf die Behandlung mit Risankizumab in einer der vorhergehenden Studie angesprochen haben, werden einer von drei verschiedenen Behandlungsgruppen zugewiesen: 2 Gruppen mit Risankizumab und 1 Gruppe mit Placebo. Die Patienten, die in der vorangegangenen Studie auf Placebo angesprochen haben, bleiben auf Placebo. Die Studie ist verblindet, das heisst, dass weder der Patient noch der Arzt wissen, welche Behandlung der Patient erhält.
Wenn in Teilstudie 1 genügend Patienten eingeschlossen wurden, können Patienten an der Teilstudie 2 teilnehmen. Teilstudie 2 dauert ebenfalls 52 Wochen, wobei die Wirksamkeit und Sicherheit von Risankizumab in zwei unterschiedlichen Behandlungsschemata untersucht werden.
Patienten, welche die Teilstudie 1 oder 2 abschliessen, können an Teilstudie 3 teilnehmen. Bei Teilstudie 3 handelt es sich um eine offene langfristige Fortsetzungsstudie zur Erhebung von Daten zur Sicherheit. Die Patienten erhalten Risankizumab entsprechend ihrer Behandlung in Teilstudie 1 oder 2: Teilstudie 3 wird fortgeführt, bis Risankizumab zugelassen oder die Studie abgebrochen wird.
Interventions
(Data source: WHO)
Drug: Placebo for Risankizumab SC;Drug: Risankizumab IV;Drug: Placebo for Risankizumab IV;Drug: Risankizumab SC;Drug: Risankizumab On-Body Injector (OBI)
Criteria for participation in trial
(Data source: BASEC)
1. Patienten, welche die Studie M15-991 oder M16-006 abgeschlossen und ein klinisches Ansprechen erreicht haben.
Exclusion criteria
(Data source: BASEC)
1. Bekannte Überempfindlichkeit gegenüber Risankizumab oder den Hilfsstoffen der Prüfpräparate oder ein unerwünschtes Ereignis während der Studie M15-991 bzw. M16-006, wodurch der Patient nach Einschätzung des Studienarztes für die Teilnahme an der Studie nicht geeignet ist.
2. Patient hat die vorherigen und begleitenden Medikamentenanforderungen in den Studien M15-991 oder M16-006 nicht eingehalten.
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Participants who have entered and completed Study M16-006 or Study M15-991 or other
AbbVie risankizumab Crohn's disease study.
- Participants have completed the study M16-006 or M15-991 and have achieved clinical
response.
- Sub-Study 4:
- Participants receiving maintenance treatment in Sub-study 3 and willing to comply
with the requirements of Sub-study 4, including self-administration of
sub-cutaneous injections using the on-body injector (OBI).
- Participant has received at least 16 weeks of stable dosing with risankizumab in
Sub-study 3 (i.e., no rescue within 16 weeks and participant has surpassed the
72-week mark).
Exclusion Criteria:
- Participants should not be enrolled in Study M16-000 with high grade colonic dysplasia
or colon cancer identified during Study M15-991, Study M16-006 or another AbbVie
risankizumab Crohn's disease study if the final endoscopy was performed prior to enter
Study M16-000 OR 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 another AbbVie risankizumab
Crohn's disease study 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 another AbbVie risankizumab Crohn's disease
study.
- Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study
M15-991 or another AbbVie risankizumab Crohn's disease study.
- 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.
-
Further information on trial
Date trial registered
Apr 4, 2017
Incorporation of the first participant
Apr 9, 2018
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission;Sub-Study 1: Percentage of Participants With Endoscopic Response;Sub-Study 3: Number of Participants With Adverse Events;Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration;Sub-Study 4: Percentage of Participants who had no Potential Hazards;Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16;Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16
Secundary end point
(Data source: WHO)
Sub-Study 1: Percentage of Participants With Clinical Remission;Sub-Study 1: Percentage of Participants With CDAI Clinical Remission Among Participants With CDAI Clinical Remission in Week 0;Sub-Study 1: Percentage of Participants With Ulcer-Free Endoscopy;Sub-Study 1: Percentage of Participants With Endoscopic Remission;Sub-Study 1: Change From Baseline of Induction in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue);Sub-Study 1: Percentage of Participants Who Discontinued Corticosteroid Use for 90 Days and Achieved Clinical Remission in Participants Taking Steroids at Baseline;Sub-Study 1: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response;Sub-Study 1: Percentage of Participants With Stool Frequency (SF) Remission;Sub-Study 1: Percentage of Participants With Abdominal Pain (AP) Remission;Sub-Study 1: Percentage of Participants With CDAI Clinical Remission and Endoscopic Response;Sub-Study 1: Percentage of Participants With Deep Remission;Sub-Study 1: Percentage of Participants With Exposure Adjusted Occurrence of CD-related Hospitalizations From Week 0 Through Week 52
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Bern, Zurich
Countries
(Data source: WHO)
American Samoa, Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
AbbVie Medical Information
+41 41 399 16 89
medinfo.ch@abbvie.com
Contact for general information
(Data source: WHO)
AbbVie Inc.
AbbVie
Contact for scientific information
(Data source: WHO)
AbbVie Inc.
AbbVie
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
29.11.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-01426
Secondary ID (Data source: WHO)
2016-003191-50
M16-000
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