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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 64 weeks for reporting.

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 more

Secondary 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 more

Side effects data

From 2023 Phase 4 trial • 352 Patients • NCT04908475

14%

COVID-19

NASOPHARYNGITIS

HEADACHE

NAUSEA

UPPER RESPIRATORY TRACT INFECTION

DIARRHOEA

CORONARY ARTERY DISEASE

PROSTATE CANCER

100%

80%

60%

40%

20%

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

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