Multicenter, randomized, double-blind, placebo-controlled, 52-week maintenance and open-label extension study of the efficacy and safety of Risankizumab in patients with ulcerative colitis who responded to the induction treatment in study M16 067 or M16 065.
Zusammenfassung der Studie
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that leads to inflammation and bleeding of the rectal and colonic mucosa (large intestine). Currently, there are various treatment options for patients with UC: including anti-inflammatory drugs (mesalazine or steroids), immunosuppressants (azathioprine), and biologics (medications administered by injection that alter the immune response, e.g., adalimumab, infliximab, vedolizumab), but they are not always effective. Risankizumab is an investigational drug developed for the treatment of patients with inflammatory diseases such as UC. This study investigates how well Risankizumab works and how safe it is compared to placebo (no active ingredient). It is a 52-week maintenance study and an open-label (i.e., the dose is known) long-term extension study in patients with moderate to severe UC who responded to the induction therapy in studies M16 067 and M16 065.
(BASEC)
Untersuchte Intervention
Approximately 760 participants will be enrolled in the study at 400 study centers worldwide.
In the blinded (i.e., no one knows what the study participant is receiving) sub-study 1, participants will receive Risankizumab or placebo subcutaneously (s.c., i.e., injection under the skin) every 8 weeks for 52 weeks. If needed, participants may receive Risankizumab as emergency therapy.
In sub-study 2, participants will receive placebo intravenously (i.v.) and Risankizumab s.c. or Risankizumab i.v. and placebo s.c. at the first visit. All participants will then receive Risankizumab s.c. at week 8 and, if needed, Risankizumab i.v. as emergency therapy.
All participants who complete sub-studies 1 and 2 may transition to long-term extension study 3 and receive Risankizumab every 8 weeks.
(BASEC)
Untersuchte Krankheit(en)
Ulcerative Colitis (UC)
(BASEC)
1. Inclusion in and completion of study M16 067 or M16 065. A final endoscopy is required for completion of study M16 067 or M16 065. 2. Clinical response at the last visit in study M16 067 or M16 065. (BASEC)
Ausschlusskriterien
1. Patients deemed ineligible for the study by the investigator for any reason. 2. Known hypersensitivity to Risankizumab or the excipients of the study medications or the components of the CHO cell line, or an adverse event (AE) during study M16 067 or M16 065 that the investigator deems renders the patient ineligible for the study. (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
AbbVie Inc., North Chicago USA AbbVie AG, Cham
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Franzisca Rusca
+41 41 399 16 89
franzisca.rusca@clutterabbvie.comAbbVie Medical Information
(BASEC)
Allgemeine Auskünfte
AbbVie
(ICTRP)
Wissenschaftliche Auskünfte
AbbVie
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
19.11.2018
(BASEC)
ICTRP Studien-ID
NCT03398135 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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 Who Responded to Induction Treatment in M16-067 or M16-065 (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (ICTRP)
Untersuchte Krankheit(en)
Ulcerative Colitis (UC) (ICTRP)
Untersuchte Intervention
Drug: risankizumab;Drug: placebo for risankizumab (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: 80 Years
Minimum age: 16 Years
Inclusion Criteria:
- Participants who have completed Study M16-067 and have achieved clinical response as
defined in the protocol.
Exclusion Criteria:
- Participants who have 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 M16-067 that in the Investigator's judgment makes
the participant unsuitable for this study.
- Participant is considered by the Investigator, for any reason, to be an unsuitable
candidate for the study.
- Participant is not in compliance with prior and concomitant medication requirements
throughout Studies M16-067. (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Sub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score;Percentage of Participants with Adverse Events (AE) (ICTRP)
Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement;Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement;Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission;Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with no Corticosteroid Use for 90 days;Sub-Study 1: Percentage of Participants with Clinical Remission per Adapted Mayo Score in Participants with a Clinical Remission at Week 0;Sub-Study 1: Percentage of Participants Achieving No Bowel Urgency;Sub-Study 1: Percentage of Participants Achieving No Abdominal Pain;Sub-Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Remission;Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement in Participants with Endoscopic Improvement at Week 0;Sub-Study 1: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score;Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue);Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ);Sub-Study 1: Percentage of Participants Achieving No Nocturnal Bowel Movements;Sub-Study 1: Percentage of Participants Achieving No Tenesmus;Sub-Study 1: Change in Number of Fecal Incontinence Episodes per Week;Sub-Study 1: Change in Number of Days per Week with Sleep Interrupted due to UC Symptoms;Sub-Study 1: Percentage of Participants with Exposure Adjusted Occurrence of Ulcerative Colitis (UC) Related Hospitalization (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
ABBVIE INC., AbbVie (ICTRP)
Sekundäre IDs
2023-506994-36-00, M16-066 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03398135 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar