Crohn's Disease: Pharmacokinetics, Efficacy, and Safety of Risankizumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease
T
Tina Zhang
Primary Investigator
Enrolling By Invitation
2-18 years
All
Phase
N/A
4 participants needed
2 Locations
Brief description of study
What is this study about?
The objective of this study is to assess the pharmacokinetics (PK), efficacy, and safety of risankizumab in pediatric subjects with moderately to severely active CD aged 2 to < 18 years old who have had intolerance or inadequate response to aminosalicylates, oral locally acting corticosteroids, systemic corticosteroids, IMMs, and/or
biologic therapies.
biologic therapies.
Approximately 110 pediatric subjects with moderately to severely
active CD will be enrolled.
active CD will be enrolled.
PK Cohort 1: Approximately 12 subjects aged 12 to < 18 years and approximately 12 subjects aged 6 to < 12 years at Baseline.
PK Cohort 2: Approximately 3 subjects aged 2 to < 6 years at Baseline.
Expansion Cohort 3: Approximately 83 subjects aged 2 to < 18 years at Baseline.
PK Cohort 2: Approximately 3 subjects aged 2 to < 6 years at Baseline.
Expansion Cohort 3: Approximately 83 subjects aged 2 to < 18 years at Baseline.
Detailed description of study
What happens during the study?
- Total study duration includes a 35-day screening period and a 140-day follow up period from the last dose of study drug for all subjects who do not complete the study or do not transition to commercially available risankizumab.
- The study includes 2 sequential lead-in PK cohorts (Cohorts 1 and 2) which enroll to confirm the dose followed by an expansion cohort (Cohort 3).
- Each cohort participates in all 3 sub-studies.
- In SS1, cohorts will receive a weight-based dose of risankizumab intravenously (IV) equivalent to the 600 mg adult dose at Baseline, Week 4, and Week 8. Study drug will be administered via IV infusion.
- In SS2, subjects will be randomized in a 1:1 ratio to receive subcutaneous (SC) risankizumab doses equivalent to the 180 mg or 360 mg adult dose every 8 weeks (q8w) via prefilled syringe (PFS) starting at Week 12.
- In SS3, subjects continue Risankizumab treatment q8w via PFS from Week 64 until up to Week 272 with dosing determined by history of rescue therapy use.
- Study drug in SS2 and SS3 may be administered via PFS in 75 mg/0.83 mL, 90 mg/1.0 mL, 150 mg/1.0 mL, and 180 mg/1.2 mL formulations.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chrohn's disease, CD
-
Age: Between 2 Years - 18 Years
-
Gender: All
Inclusion criteria
- Moderately to severely active Crohn's Disease (CD)
- Had intolerance or inadequate response to aminosalicylates, oral locally acting corticosteroids, systemic corticosteroids, IMMs, and/or biologic therapies
Updated on
01 Aug 2024.
Study ID: PGI-ABBVIE-M16-194, 20201
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