Crohn's Disease
Risankizumab in Children With Moderately to Severely Active Crohn's Disease
This study is assessing how risankizumab moves through the body, its safety, and changes in disease activity among children ages 2–17 with moderately to severely active Crohn’s disease and an inadequate response or intolerance to other therapies.
Registry title: 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
11 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Risankizumab
- Design
- Randomized · Quadruple
- Central study contact
- ABBVIE CALL CENTER844-663-3742abbvieclinicaltrials@abbvie.com
- Sponsor
- AbbVie
Research question
How does weight-based risankizumab move through the body, affect Crohn’s disease activity, and relate to safety outcomes in children with moderately to severely active Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for children ages 2 through 17.
- The study is looking for children with moderately to severely active Crohn’s disease.
- Disease activity must include a Pediatric Crohn’s Disease Activity Index score above 30 at baseline.
- Participants must have endoscopic evidence of intestinal lining inflammation and intolerance or an inadequate response to at least one listed therapy category.
Participation overview
What participation may involve
Participation may involve intravenous risankizumab induction, randomized subcutaneous maintenance, an open-label subcutaneous extension, clinic visits, medical assessments, blood tests, side-effect checks, and questionnaires. What participation may involve: - Receive weight-based risankizumab by intravenous infusion during the open-label induction period. - If entering maintenance, receive one of two randomized risankizumab doses by subcutaneous injection under blinded conditions. - Participants completing maintenance may have an opportunity to enter an open-label extension, with dosing based on their maintenance response. - Attend regular hospital or clinic visits for medical assessments, blood tests, side-effect monitoring, and questionnaires. The registry describes a 12-week induction period, a 52-week maintenance period, a 208-week open-label extension, and approximately 140 days of follow-up; not every participant necessarily enters every period. The registry states that participants attend regular visits at a hospital or clinic, but it does not give the number or frequency of visits.
Study interventions
What participants may receive or do
- Risankizumab: Participants receive weight-based risankizumab through an intravenous infusion during the 12-week open-label induction period.
- Risankizumab: Participants receive risankizumab by subcutaneous injection during the randomized maintenance period and, when applicable, the open-label extension period.
Study design
How the comparison works
This phase 3 treatment study uses sequential periods: open-label induction, randomized and blinded maintenance, and an open-label extension. All registry arms receive risankizumab. After completing the induction period, participants entering the 52-week maintenance period are randomly assigned to one of two risankizumab doses. During randomized maintenance, the participant, care provider, investigator, and outcomes assessor are masked to the assigned risankizumab dose. The randomized maintenance period compares two risankizumab dose groups; the registry does not describe a non-risankizumab control group.
Reported activities
Procedures and tests
- Medical assessments are used to check the effects of treatment.
- Blood tests are performed during the study.
- The study checks for side effects.
- Participants complete questionnaires.
- The Pediatric Crohn’s Disease Activity Index assesses symptoms, functioning, laboratory measures, growth, physical findings, and disease outside the intestine.
- Endoscopic disease activity is assessed with the Simple Endoscopic Score for Crohn’s Disease.
- For cohorts 1 and 2, blood measurements assess risankizumab concentration and how it changes over a dosing interval.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 2 to younger than 18 years old.
- Crohn’s disease must be moderately to severely active, defined as a Pediatric Crohn’s Disease Activity Index score above 30 at baseline.
- Endoscopy must show mucosal inflammation, with a Simple Endoscopic Score for Crohn’s Disease of at least 6 for ileocolonic or colonic disease, or at least 4 for isolated ileal disease.
- Participants must have been intolerant of or had an inadequate response to at least one listed therapy category; aminosalicylates alone do not meet this requirement in France, Italy, the Netherlands, Spain, or Sweden.
Possible reasons someone may not be able to join
- A history of hereditary fructose intolerance, or an allergic reaction or significant sensitivity to the study drug’s ingredients or related products, is exclusionary.
- A current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic inflammatory bowel disease is exclusionary.
- Children whose Crohn’s disease was diagnosed before age 2 are excluded.
- A diagnosed or suspected primary immunodeficiency is exclusionary.
- Certain current Crohn’s disease complications are exclusionary, including an active abdominal or perianal abscess, symptomatic bowel strictures, fulminant colitis, toxic megacolon, or another manifestation that might require surgery during the study.
- An ostomy or ileoanal pouch is exclusionary.
- Short gut or short bowel syndrome is exclusionary.
- Participants are excluded after bowel resection within 3 months before baseline, except specified gastrointestinal operations that are not bowel resections, or if they have a history of more than three bowel resections.
Important unknowns
What the record does not make clear
- The registry says visits are regular and occur at a hospital or clinic but does not report their number, timing, or length.
- The registry does not explain which current Crohn’s disease medicines may continue during the study.
- The registry does not provide washout requirements or medication timing rules.
- The registry does not describe treatment available if Crohn’s disease worsens during the study.
- Endoscopic evidence is required at baseline and endoscopic outcomes are measured, but the registry does not give the complete endoscopy schedule.
- The registry does not state which study-related or routine-care costs are covered.
- The registry does not report whether participants or families receive compensation or reimbursement.
- The registry does not describe support for transportation, lodging, meals, or caregiver travel.
- The registry describes hospital or clinic visits but does not say whether any visits or assessments may be completed remotely.
- The registry does not describe access to risankizumab after study participation ends.
- The study is recruiting overall and lists recruiting locations, but the registry does not establish which age cohort or substudy is open at each site.
Before contacting the site
Questions for the study team
- Which age cohort and substudy is the preferred location currently enrolling?
- What is the exact visit, infusion, injection, blood-draw, and endoscopy schedule for each period?
- Which current Crohn’s disease medicines can continue, and are any washout periods required?
- What happens if disease symptoms or inflammation worsen during induction, maintenance, or extension?
- What determines whether a participant enters maintenance and the long-term extension?
- Which study-related costs are covered, and is travel or caregiver reimbursement available?
- What care and access to risankizumab are available after participation ends?
Before changing care
Questions for your gastroenterologist
- How stable is the child’s Crohn’s disease now, and what risks could come from changing current treatment for screening or participation?
- What approved treatment alternatives remain, and how do their known burdens and uncertainties compare with this study’s requirements?
- Are the required disease-activity and endoscopic assessments appropriate in the child’s current clinical situation?
- How should the gastroenterology team and research team coordinate routine care, worsening symptoms, laboratory results, and urgent decisions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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. Approximately 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.
Study design and administration
- Organization
- AbbVie
- Organization class
- Industry
- Organization study ID
- M16-194
- Lead sponsor
- AbbVie
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Sequential
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child
Study arms
Experimental
PK Cohort 1: SS1
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 participants who complete SS1 are eligible to enter SS2.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 1: SS2 Dose A
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.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 1: SS2 Dose B
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.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 1: SS3 Dose A
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.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 1: SS3 Dose B
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.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 2: SS1
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.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 2: SS2 Dose A
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.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 2: SS2 Dose B
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.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 2: SS3 Dose A
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.
Interventions: Drug: Risankizumab
Experimental
PK Cohort 2: SS3 Dose B
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.
Interventions: Drug: Risankizumab
Experimental
Expansion Cohort 3: SS1
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.
Interventions: Drug: Risankizumab
Experimental
Expansion Cohort 3: SS2 Dose A
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.
Interventions: Drug: Risankizumab
Experimental
Expansion Cohort 3: SS2 Dose B
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.
Interventions: Drug: Risankizumab
Experimental
Expansion Cohort 3: SS3 Dose A
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.
Interventions: Drug: Risankizumab
Experimental
Expansion Cohort 3: SS3 Dose B
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.
Interventions: Drug: Risankizumab
Interventions
Drug
Risankizumab
Intravenous (IV) Infusion
Drug
Risankizumab
Subcutaneous (SC) Injection
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (4)
- Pediatric individuals, 2 to \< 18 years oldRegistry-derived · unreviewed
- Must have moderately to severely active CD, as defined by the PCDAI score \> 30 assessed at BaselineRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapiesRegistry-derived · unreviewed
Exclusion criteria (15)
- History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same classRegistry-derived · unreviewed
- Any of the following medical disorders:Registry-derived · unreviewed
- Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.Registry-derived · unreviewed
- A diagnosis of CD prior to 2 years of age.Registry-derived · unreviewed
- A diagnosis or suspected diagnosis of a primary immunodeficiency.Registry-derived · unreviewed
- Currently known complications of CD such as:Registry-derived · unreviewed
- Active abscess (abdominal or perianal);Registry-derived · unreviewed
- Symptomatic bowel strictures;Registry-derived · unreviewed
- \> 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;Registry-derived · unreviewed
- Fulminant colitis;Registry-derived · unreviewed
- Toxic megacolon;Registry-derived · unreviewed
- Or any other manifestation that might require surgery while enrolled in the study.Registry-derived · unreviewed
- Ostomy or ileoanal pouch.Registry-derived · unreviewed
- Diagnosis of short gut or short bowel syndrome.Registry-derived · unreviewed
- Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of \>3 bowel resections.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Time frame: At 64 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Primary outcome
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: At 64 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Primary outcome
Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab
Time frame: Up to approximately Week 64
Cmax of risankizumab
Primary outcome
Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab
Time frame: Up to approximately 64 weeks
Tmax of risankizumab
Primary outcome
Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
Time frame: Up to approximately 64 weeks
AUCtau of risankizumab
Secondary outcome
Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
Time frame: At 12 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Secondary outcome
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
Time frame: At 12 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Secondary outcome
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Time frame: At 12 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score \> 1, as scored by a central reader.
Secondary outcome
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Time frame: At 64 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score \> 1, as scored by a central reader.
Secondary outcome
Cohort 3 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
Time frame: At 64 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
Secondary outcome
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving PCDAI Clinical Remission
Time frame: At 64 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Secondary outcome
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per SES-CD
Time frame: At 64 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Secondary outcome
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
Time frame: At 12 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10.
Secondary outcome
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
Time frame: At 12 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Secondary outcome
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Time frame: At 12 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score \> 1, as scored by a central reader.
Secondary outcome
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
Time frame: At 64 weeks
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score \> 1, as scored by a central reader.
Secondary outcome
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
Time frame: At 64 weeks
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.
Recruiting locations in the United States
Phoenix Children's Hospital /ID# 255766
RecruitingPhoenix, Arizona, 85016-7710, United States
Arkansas Children's Hospital /ID# 255762
RecruitingLittle Rock, Arkansas, 72202, United States
UCSF Benioff Children's Hospital - Oakland /ID# 258327
RecruitingOakland, California, 94609, United States
Children's Hospital Colorado - Aurora /ID# 255764
RecruitingAurora, Colorado, 80045, United States
Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437
RecruitingOrlando, Florida, 32806-1141, United States
Indiana University Health Riley Hospital for Children /ID# 256454
RecruitingIndianapolis, Indiana, 46202, United States
Massachusetts General Hospital /ID# 255767
RecruitingBoston, Massachusetts, 02114, United States
MNGI Digestive Health, P. A. /ID# 255366
RecruitingMinneapolis, Minnesota, 55413-2195, United States
Goryeb Childrens Hospital /ID# 256452
RecruitingMorristown, New Jersey, 07960, United States
Icahn School of Medicine at Mount Sinai /ID# 254880
RecruitingNew York, New York, 10029, United States
Cleveland Clinic - Cleveland /ID# 256453
RecruitingCleveland, Ohio, 44195, United States
Site Coordinator216-636-2007
This study also lists 74 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Aug 16, 2023
- Primary completion
- Apr 2029
- Overall completion
- Apr 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.