Crohn's Disease: Pharmacokinetics, Efficacy, and Safety of Risankizumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease
Studying an Investigational Medication for Children with Crohn's Disease
Tina Zhang
Primary Investigator
Brief description of study
Detailed description of 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, Riley
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Age: 16 years - 80 years
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Gender: All
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.
This study investigates the effects of an investigational medication on children with moderately to severely active Crohn's Disease. Crohn's Disease is a condition that causes inflammation in the digestive tract, leading to symptoms like stomach pain and diarrhea. The purpose of this study is to learn more about how the investigational medication works in the body, its safety, and how well it helps manage Crohn's Disease in children.
Participants in the study will receive the investigational medication in different ways. Initially, they will get a dose through a drip into their vein at set times. Later, they will receive the medication through a needle under the skin every eight weeks. The study will also look at how participants respond to the medication over time and how their bodies process it.
- Who can participate: Children who completed previous related studies and responded to treatment are eligible. Participants must not have certain health issues like high-grade colonic dysplasia or cancer and should not be allergic to the investigational medication.
- Study details: Participants will receive the investigational medication either through an IV or as an injection under the skin. The study will monitor the medication's effects on Crohn's Disease and its safety.
- Study timelines: The study will last for a total of 175 days, including a 35-day screening period and a 140-day follow-up period.
