Crohn's Disease: Pharmacokinetics, Efficacy, and Safety of Risankizumab in Pediatric Study Participants with Moderate to Severe Crohn's Disease
Descrizione riassuntiva dello studio
Crohn's disease (CD) is a gastrointestinal disorder that can cause chronic diarrhea with or without significant bleeding, abdominal pain, weight loss, and fever. This study examines the pharmacokinetics, efficacy, and safety of Risankizumab in children and adolescents aged 2 to < 18 years with moderate to severe active CD who are intolerant to other therapies or have responded inadequately. Risankizumab is an approved medication for adults with plaque psoriasis, psoriatic arthritis, and CD, and is being developed for the treatment of CD in pediatrics. This study consists of 3 cohorts that may participate in 3 sub-studies (SS). In cohort 1, patients aged 6 to under 18 years are enrolled. In cohort 2, patients aged 2 to under 6 years are enrolled. In cohort 3, patients aged 2 to under 18 years are enrolled. SS1 is an open-label induction phase where participants receive a weight-based induction therapy with Risankizumab. SS2 is a double-blind maintenance phase where participants are randomized to receive one of two doses of the weight-based induction therapy with Risankizumab. SS3 is an open continuation phase where participants receive Risankizumab based on their response in SS2. Approximately 110 children and adolescents with CD will be enrolled at approximately 100 study centers worldwide.
(BASEC)
Intervento studiato
Participants in SS1 receive Risankizumab intravenously during the 12-week induction phase. Participants in SS2 receive Risankizumab subcutaneously during the 52-week randomized maintenance phase. Participants in SS3 receive Risankizumab subcutaneously during the 208-week open phase. Participants will be followed for approximately 140 days.
(BASEC)
Malattie studiate
Crohn's Disease
(BASEC)
– Children and adolescents aged 2 to < 18 years – Moderate to severe active CD, defined as a PCDAI score > 30, assessed at baseline – Endoscopic evidence of mucosal inflammation, documented by an SES CD of 6 for ileocolonic or colonic disease (or an SES CD of 4 for isolated ileal disease). – Documented intolerance or inadequate response to one or more of the following drug classes: aminosalicylates, oral locally acting corticosteroids, systemic steroids (prednisone or corresponding active ingredient), IMMs and/or biologics (BASEC)
Criteri di esclusione
– Allergic reaction or significant sensitivity to any component of the investigational product (and excipients) and/or other drugs of the same class – Any of the following conditions: (a) Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD (b) CD diagnosis at age < 2 years (c) Diagnosis or suspicion of primary immunodeficiency (d) Currently known complications related to CD, including: -- Active abscess (abdominal or perianal) -- Symptomatic intestinal strictures -- > 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigma, and left colon as well as rectum -- Fulminant colitis -- Toxic megacolon -- Or any other manifestations that may require surgical intervention during the study (e) Stoma or ileoanal pouch (f) Diagnosis of short bowel syndrome (g) Surgical intestinal resection within 3 months prior to baseline (except gastrointestinal surgeries that do not involve intestinal resection, such as appendectomy or stoma closure) or > 3 intestinal resections in the history (BASEC)
Luogo dello studio
Berna, Zurigo
(BASEC)
Sponsor
AbbVie Inc. North Chicago USA AbbVie AG Cham
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
AbbVie Medical Information
+41 41 399 16 89
medinfo.ch@clutterabbvie.comAbbVie AG
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
13.02.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab with Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) with Moderately to Severely Active Crohn's Disease (BASEC)
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Endpoint primari e secondari
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Risultati dello studio
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