Multicenter, randomized, double-blind, placebo-controlled, 52-week maintenance and open-label extension study of the efficacy and safety of Risankizumab in patients with Crohn's disease who have responded to the induction treatment in study M16-006 or M15-991.
Descrizione riassuntiva dello studio
Crohn's disease (CD) is a chronic inflammatory condition affecting various sections of the intestine. CD can cause fatigue, diarrhea (with or without blood in the stool), abdominal pain, weight loss, and fever. Risankizumab is an investigational drug developed for the treatment of inflammatory diseases. All patients with CD who have completed study M15-991 or M16-006 and have responded to treatment may be eligible to participate in this study.
(BASEC)
Intervento studiato
The study consists of 3 parts and approximately 912 patients with CD will participate in this study worldwide.
Part 1 lasts 52 weeks, during which the efficacy and safety of Risankizumab will be compared to placebo (a drug without active ingredient) and whether the symptoms of CD continue to reduce. Approximately 450 patients who have responded to treatment with Risankizumab in one of the previous studies will be assigned to one of three different treatment groups: 2 groups receiving Risankizumab and 1 group receiving placebo. Patients who responded to placebo in the previous study will remain on placebo. The study is blinded, meaning that neither the patient nor the doctor knows which treatment the patient is receiving.
When enough patients have been enrolled in Part 1, patients may participate in Part 2. Part 2 also lasts 52 weeks, during which the efficacy and safety of Risankizumab will be studied in two different treatment regimens.
Patients who complete Part 1 or 2 may participate in Part 3. Part 3 is an open-label long-term extension study to collect safety data. Patients will receive Risankizumab according to their treatment in Part 1 or 2: Part 3 will continue until Risankizumab is approved or the study is terminated.
(BASEC)
Malattie studiate
Crohn's disease (CD)
(BASEC)
1. Patients who have completed study M15-991 or M16-006 and have achieved a clinical response. (BASEC)
Criteri di esclusione
1. Known hypersensitivity to Risankizumab or the excipients of the investigational products or an adverse event during study M15-991 or M16-006 that, in the opinion of the investigator, makes the patient unsuitable for participation in the study. 2. The patient did not adhere to the prior and concomitant medication requirements in studies M15-991 or M16-006. (BASEC)
Luogo dello studio
Basilea, Berna, Zurigo
(BASEC)
Sponsor
AbbVie Inc. North Chicago USA AbbVie AG Cham
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Franzisca Rusca
+41 41 399 16 89
franzisca.rusca@clutterabbvie.comAbbVie AG Medical Information
(BASEC)
Informazioni generali
AbbVie
(ICTRP)
Informazioni scientifiche
AbbVie
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
29.11.2017
(BASEC)
ID di studio ICTRP
NCT03105102 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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 Who Responded to Induction Treatment in M16-006 or M15-991 (BASEC)
Titolo accademico
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 (ICTRP)
Titolo pubblico
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (ICTRP)
Malattie studiate
Crohn's Disease (ICTRP)
Intervento studiato
Drug: Placebo for Risankizumab SC;Drug: Risankizumab IV;Drug: Placebo for Risankizumab IV;Drug: Risankizumab SC;Drug: Risankizumab On-Body Injector (OBI) (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: 80 Years
Minimum age: 16 Years
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. (ICTRP)
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Endpoint primari e secondari
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 (ICTRP)
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 (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
ABBVIE INC., AbbVie (ICTRP)
ID secondari
2023-506399-28-00, M16-000 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03105102 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile