Crohn DiseaseNCT06298188
Risankizumab in Children With Crohn's Disease (RisaKids)
A study testing Risankizumab in people with Crohn Disease, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Risankizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children under the age of 18 years,
- Patients diagnosed with CD.
- Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.
Who cannot join
- There will be no exclusion criteria to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study
The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.
This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.
- Conditions
- Crohn Disease
- Being tested
- Risankizumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisankizumabDrug
Risankizumab
| Study group | Role | What they receive |
|---|---|---|
| Risankizumab | Experimental | Induction regimen: 0,4,8 IV and then every 8 weeks sc Receives: Drug: Risankizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) as defined by the fulfilment of all three criteria:
- Corticosteroids and enteral nutrition free ii. Clinical remission (i.e. PCDAI<10) iii. CRP lower than 1 mg/dl (may be substituted by ESR if CRP missing)
Measured: Through study completion, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start31 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Amit Assa, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298188
- Sponsor's protocol ID
- RisaKids
- Status last verified
- Feb 2024
- First submitted
- 24 Oct 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study
- ClinicalTrials.gov ID
- NCT06298188
- Acronym / sponsor ID
- RisaKids
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.
This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risankizumab | Experimental | Drug: RisankizumabInduction regimen: 0,4,8 IV and then every 8 weeks sc |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children under the age of 18 years,
- Patients diagnosed with CD.
- Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.
Key exclusion criteria (1 listed)
- There will be no exclusion criteria to this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisankizumabRisankizumab | Drug | Risankizumab |
Primary outcome
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)
Time frame: Through study completion, approximately 3 years
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) as defined by the fulfilment of all three criteria: i. Corticosteroids and enteral nutrition free ii. Clinical remission (i.e. PCDAI<10) iii. CRP lower than 1 mg/dl (may be substituted by ESR if CRP missing)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risankizumab in people with Crohn Disease, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nataly Kawazba (97225645254, natalyk@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) (time frame: Through study completion, approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.