Health conditions
(Datenquelle: WHO)
Ulcerative Colitis
MedDRA version: 20.0Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions (Datenquelle: WHO)
Product Name: Risankizumab
Product Code: ABBV-006
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
Current Sponsor code: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Product Name: Risankizumab
Product Code: ABBV-066
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: RISANKIZUMAB
Current Sponsor code: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 90-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Risankizumab
Product Code: ABBV-006
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RISANKIZUMAB
Current Sponsor code: ABBV-066
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Inclusion/Exclusion Criteria
(Datenquelle: WHO)
Gender:
Female: yes
Male: yes
Inclusion criteria:
Entry and completion of Study M16-067. Completion includes the final endoscopy of Study M16-067. If the final endoscopy for Study M16-067 is missing during the COVID-19 pandemic due to local regulation prohibiting endoscopy, or due to the geo-political conflict in Ukraine and surrounding impacted regions, subjects may be allowed to enroll in Sub-study 3 should they meet clinical response.
Achieved clinical response at the last visit of Study M16-067.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 894
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
Exclusion criteria:
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Study M16-067 or Study M16-065 that in the Investigator's judgment makes the subject unsuitable for this study.
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Weitere Informationen zur Studie
Datum der Studienregistrierung
15.06.2018
Einschluss der ersten teilnehmenden Person
22.01.2019
Rekrutierungsstatus
Authorised-recruitment may be ongoing or finished
Wissenschaftlicher Titel
(Datenquelle: 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 Ulcerative Colitis
Studientyp
(Datenquelle: WHO)
Interventional clinical trial of medicinal product
Design der Studie
(Datenquelle: WHO)
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 6
Phase
(Datenquelle: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primäre Endpunkte
(Datenquelle: WHO)
Main Objective: Sub-study 1:
To evaluate efficacy and safety of risankizumab versus placebo as
maintenance therapy in subjects with moderately to severely active
ulcerative colitis (UC) responded to IV risankizumab induction treatment
in Study M16-067
Sub-study 2:
To evaluate efficacy and safety of two different dosing regimens for
risankizumab (therapeutic drug monitoring vs clinical assessment for
dose escalation) as maintenance therapy in subjects with moderately to
severely active UC responded to induction treatment in Study M16-067
Sub-study 3:
To evaluate long-term safety of risankizumab in subjects who completed
Sub-study 1 or 2 or subjects who responded to induction treatment in
Study M16-067 with no final endoscopy due to the COVID-19 pandemic
or the geo-political conflict in Ukraine and surrounding impacted regions.
Additional objectives are to further investigate long-term efficacy and
tolerability of risankizumab.
CTE: Investigate and evaluate long-term safety data for risankizumab;Secondary Objective: Not applicable;Primary end point(s): Sub-study 1 or 2 : The achievement of clinical remission per Adapted Mayo score at Week 52.
Sub-study 2: Selected efficacy endpoints as those listed in Sub-study 1 but comparing the Therapeutic Drug Monitoring vs Clinical Assessment arms as exploratory purpose.
Sub-study 3: Evaluation of long-term safety
There are no efficacy endpoints for CTE.;Timepoint(s) of evaluation of this end point: Week 52
Sekundäre Endpunkte
(Datenquelle: WHO)
Secondary end point(s): 1. The achievement of endoscopic improvement at Week 52.
2. The achievement of histologic endoscopic improvement of the mucosa at Week 52.
3. The achievement of endoscopic remission at Week 52.
4. The achievement of clinical remission per Full Mayo score
at Week 52 with no corticosteroid use for 90 days.
5. The achievement of clinical remission per Adapted Mayo score at Week 52 in subjects with clinical remission at Week 0.
6. The achievement of no bowel urgency at Week 52.
7. The achievement of abdominal pain at Week 52.
8. The achievement of histologic endoscopic mucosal remission at Week 52.
9. The achievement of endoscopic improvement at Week 52 in subjects with endoscopic improvement at Week 0.
10. The achievement of clinical response per Adapted Mayo score at Week 52.
11. Change from Baseline (of induction) to Week 52 in FACIT-Fatigue.
12. Change from Baseline (of induction) to Week 52 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.
13. The achievement of no nocturnal bowel movements at Week 52.
14. The achievement of no tenesmus at Week 52.
15. Change from Baseline (of induction) to Week 52 in number of fecal incontinence episodes per week.
16. Change from Baseline (of induction) to Week 52 in number of days over a week with sleep interrupted due to UC symptoms.
17. Exposure adjusted Occurrence of UC-related hospitalizations through Week 52.;Timepoint(s) of evaluation of this end point: Week 52
Kontakt für Auskünfte
(Datenquelle: WHO)
AbbVie Inc
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
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 Ulcerative Colitis
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsländer
(Datenquelle: WHO)
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Republic of, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, T?rkiye, Taiwan, Ukraine, United Kingdom, United States
Kontakt für weitere Auskünfte zur Studie
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Global Clinical Trials Contact
Knollstrasse
AbbVie Deutschland GmbH & Co. KG
+4961117201520
global-clinical-trials@abbvie.com
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Global Clinical Trials Contact
Knollstrasse
AbbVie Deutschland GmbH & Co. KG
+4961117201520
global-clinical-trials@abbvie.com
Weitere Studienidentifikationsnummern
Secondary ID (Datenquelle: WHO)
M16-066
2016-004676-22-BE
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