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Monoclonal Antibodies
Risankizumab for Pediatric Crohn's Disease (RISE Trial)
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 64 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will assess a drug, risankizumab, to treat Crohn's Disease in pediatric participants aged 2 to < 18. Participants will receive risankizumab intravenously or subcutaneously, and be monitored for side effects and efficacy.
Who is the study for?
This trial is for kids aged 2 to <18 with moderate to severe Crohn's Disease who haven't responded well or can't tolerate other treatments. They need a certain score on a disease activity index and visible inflammation in their guts. Kids with allergies to the drug, different bowel diseases, complications needing surgery, or those who've had too many gut surgeries can't join.
What is being tested?
The study tests Risankizumab, an approved adult drug for psoriasis and arthritis now being tried for pediatric Crohn's Disease. It involves three parts: initial treatment (SS1), comparing two doses (SS2), and long-term follow-up (SS3). The drug will be given through veins first then as shots under the skin.
What are the potential side effects?
Risankizumab may cause immune system reactions like infections since it targets specific pathways involved in inflammation. There might also be injection site reactions or allergic responses among other potential side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 64 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 64 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
+2 moreSecondary study objectives
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
+9 moreSide effects data
From 2023 Phase 4 trial • 352 Patients • NCT0490847514%
COVID-19
8%
NASOPHARYNGITIS
4%
HEADACHE
3%
NAUSEA
3%
UPPER RESPIRATORY TRACT INFECTION
1%
DIARRHOEA
1%
CORONARY ARTERY DISEASE
1%
PROSTATE CANCER
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period B: APR/APR
Period A: APR
Period A: RZB
Period B: RZB/RZB
Period B: APR/RZB
Period B: APR/APR/RZB
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
15Treatment groups
Experimental Treatment
Group I: PK Cohort 2: SS3 Dose BExperimental Treatment1 Intervention
Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Group II: PK Cohort 2: SS3 Dose AExperimental Treatment1 Intervention
Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Group III: PK Cohort 2: SS2 Dose BExperimental Treatment1 Intervention
Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Group IV: PK Cohort 2: SS2 Dose AExperimental Treatment1 Intervention
Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Group V: PK Cohort 2: SS1Experimental Treatment1 Intervention
Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
Group VI: PK Cohort 1: SS3 Dose BExperimental Treatment1 Intervention
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Group VII: PK Cohort 1: SS3 Dose AExperimental Treatment1 Intervention
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Group VIII: PK Cohort 1: SS2 Dose BExperimental Treatment1 Intervention
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Group IX: PK Cohort 1: SS2 Dose AExperimental Treatment1 Intervention
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Group X: PK Cohort 1: SS1Experimental Treatment1 Intervention
Cohort 1 will consist of 2 age groups (6 to \< 12 years and 12 to \< 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
Group XI: Expansion Cohort 3: SS3 Dose BExperimental Treatment1 Intervention
Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Group XII: Expansion Cohort 3: SS3 Dose AExperimental Treatment1 Intervention
Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2.
Group XIII: Expansion Cohort 3: SS2 Dose BExperimental Treatment1 Intervention
Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Group XIV: Expansion Cohort 3: SS2 Dose AExperimental Treatment1 Intervention
Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive either double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3.
Group XV: Expansion Cohort 3: SS1Experimental Treatment1 Intervention
Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab
2021
Completed Phase 4
~3340
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,469 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,254 Total Patients Enrolled