Risankizumab for Pediatric Crohn's Disease

(RISE Trial)

Recruiting in Palo Alto (17 mi)

+80 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AbbVie

Disqualifiers: Ulcerative colitis, Immunodeficiency, Abscess, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies. Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 110 pediatric participants with CD will be enrolled at around 100 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Risankizumab for treating Crohn's disease?

Research shows that Risankizumab is effective in treating moderate to severe Crohn's disease, with studies demonstrating its ability to help patients achieve remission and maintain it over time.

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Is risankizumab safe for humans?

Risankizumab has been shown to have acceptable safety in patients with moderate-to-severe Crohn's disease in several studies, including long-term safety evaluations.

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How is the drug Risankizumab unique for treating Crohn's disease?

Risankizumab is unique because it targets a specific part of the immune system called interleukin-23 (IL-23), which is involved in inflammation, making it different from other treatments that may target broader immune responses. It is used both as an initial (induction) and ongoing (maintenance) therapy, and can be administered intravenously or subcutaneously (under the skin), offering flexibility in treatment.

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Eligibility Criteria

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.

Inclusion Criteria

Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)

I've had a bad reaction or no improvement from certain gut inflammation treatments.

I am between 2 and 17 years old.

Exclusion Criteria

I have been diagnosed with a form of inflammatory bowel disease.

I am allergic or highly sensitive to the study drug or similar medications.

I was diagnosed with Crohn's disease before I turned 2 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive a weight-based dose of risankizumab intravenously during the 12-week induction period

12 weeks

Regular visits at a hospital or clinic

Maintenance

Participants receive risankizumab subcutaneously during the 52-week randomized maintenance period

52 weeks

Regular visits at a hospital or clinic

Open-label Extension

Participants receive risankizumab subcutaneously during the 208-week open-label period based on their response in the maintenance phase

208 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Participant Groups

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.

Group I: PK Cohort 2: SS3 Dose B Experimental Treatment 1 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 A Experimental Treatment 1 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 B Experimental Treatment 1 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 A Experimental Treatment 1 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: SS1 Experimental Treatment 1 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 B Experimental Treatment 1 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 A Experimental Treatment 1 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 B Experimental Treatment 1 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 A Experimental Treatment 1 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: SS1 Experimental Treatment 1 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 B Experimental Treatment 1 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 A Experimental Treatment 1 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 B Experimental Treatment 1 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 A Experimental Treatment 1 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: SS1 Experimental Treatment 1 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.

Risankizumab is already approved in Canada, United States, European Union for the following indications:

🇨🇦 Approved in Canada as Skyrizi for:

• Moderate-to-severe Crohn's disease

🇺🇸 Approved in United States as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis

🇪🇺 Approved in European Union as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis
• Psoriatic arthritis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

London Health Sciences Center- University Hospital /ID# 258598 London, Canada

Goryeb Children's Hospital /ID# 256452 Morristown, NJ

Riley Hospital for Children /ID# 256454 Indianapolis, IN

Alberta Children's Hospital /ID# 255357 Calgary, Canada

More Trial Locations

Who Is Running the Clinical Trial?

AbbVie Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Risankizumab-rzaa: A New Therapeutic Option for the Treatment of Crohn's Disease. [2023] To review the pharmacologic and clinical profile of risankizumab-rzaa in the treatment of Crohn's disease (CD).

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study. [2023] Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn's disease (CD), but no real-world data are currently available. We aimed to assess the short-term effectiveness and safety of risankizumab in patients with CD.

3. England pubmed.ncbi.nlm.nih.gov

Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. [2022] There is a great unmet need for new therapeutics with novel mechanisms of action for patients with Crohn's disease. The ADVANCE and MOTIVATE studies showed that intravenous risankizumab, a selective p19 anti-interleukin (IL)-23 antibody, was efficacious and well tolerated as induction therapy. Here, we report the efficacy and safety of subcutaneous risankizumab as maintenance therapy.

4. England pubmed.ncbi.nlm.nih.gov

Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. [2022] Risankizumab, an interleukin (IL)-23 p19 inhibitor, was evaluated for safety and efficacy as induction therapy in patients with moderately to severely active Crohn's disease.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Risankizumab in patients with moderate to severe Crohn's disease: an open-label extension study. [2022] Risankizumab, an anti-interleukin 23 antibody, was superior to placebo in achieving clinical and endoscopic remission at week 12 in a randomised, phase 2 induction study in patients with moderately to severely active Crohn's disease. Here we aimed to assess the efficacy and safety of extended intravenous induction and subcutaneous maintenance therapy with risankizumab.

6. England pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study. [2022] Risankizumab, an interleukin-23 antibody, demonstrated efficacy and acceptable safety in a phase 2 study of patients with moderate-to-severe refractory Crohn's disease. This open-label extension investigated the long-term safety, pharmacokinetics, immunogenicity and efficacy of risankizumab in responders to risankizumab in the parent phase 2 study.

7. Australia pubmed.ncbi.nlm.nih.gov

Efficacy and safety of risankizumab for Crohn's disease in patients from Asian countries: a post hoc subanalysis of the global phase 3 ADVANCE, MOTIVATE, and FORTIFY studies. [2023] The anti-interleukin-23 antibody risankizumab is being investigated as a treatment for moderate-to-severe Crohn's disease. This post hoc subanalysis evaluates the efficacy and safety of risankizumab therapy in Asian patients.