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Monoclonal Antibodies

Risankizumab for Pediatric Crohn's Disease

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 2022 Phase 3 trial • 244 Patients • NCT04102007
9%
COVID-19
6%
NASOPHARYNGITIS
1%
OSTEOARTHRITIS
1%
MYOCARDIAL INFARCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risankizumab

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 3
~3140

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,280 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,999 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial encompass geriatric patients?

"Participants aged between 2 and 17 years old are eligible to join this medical trial."

Answered by AI

What is the upper limit for participants in this experiment?

"Affirmative. The information hosted on clinicaltrials.gov asserts that this medical research, first posted October 23rd 2023 is currently accepting applicants. 110 participants from 1 facility are required for the trial to continue."

Answered by AI

What risk factors should be considered when administering PK Cohort 1: SS3 Dose A to individuals?

"The safety of PK Cohort 1: SS3 Dose A has been established as a 3 on our team's rating scale due to the Phase 3 trial requirements and data that demonstrates both efficacy and multiple rounds of safety."

Answered by AI

Are researchers still accepting new participants for this investigation?

"Affirmative. According to the information found on clinicaltrials.gov, enrollment is still ongoing for this trial which was first uploaded on October 23rd 2023 and last updated 17 days later. The team in charge of the study needs to find 110 volunteers from a single site."

Answered by AI

Which subjects are ideal to include in this research trial?

"This trial is searching for 110 juvenile patients, aged between 2 and 17 years old, diagnosed with Crohn's disease. To qualify for this study, participants must meet the following requirements: pediatric age group (2-18), moderate to severe CD as indicated by a PCDAI score >30 at baseline, endoscopic evidence of mucosal inflammation verified through SES-CD ≥6 or 4 scores depending on ileal/colonic presence respectively; additionally they need to have had an inadequate response to aminosalicylates, oral corticosteroids, systemic steroids (prednisone or equivalent), IMMs or biologic"

Answered by AI

What results is this experiment hoping to bring about?

"As reported by the sponsor, AbbVie, the main objective measured over a 64-week interval is Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's disease (SES-CD). Furthermore, secondary outcomes like Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission defined as PCDAI ≤ 10., and endoscopic response/remission will be taken into account."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
2023. "A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05995353.
~73 spots leftby Apr 2029
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