Crohn's Disease
Guselkumab for Children With Moderately to Severely Active Crohn’s Disease
This phase 3 study is evaluating clinical and endoscopic outcomes with intravenous or subcutaneous guselkumab in children ages 2–17 with moderately to severely active Crohn’s disease.
Registry title: A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
12 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Guselkumab
- Design
- Randomized · Triple
- Central study contact
- Study Contact844-434-4210Participate-In-This-Study1@its.jnj.com
- Sponsor
- Janssen Research & Development, LLC
Research question
Among pediatric participants who respond to guselkumab by Week 12, what clinical and endoscopic outcomes are seen at the end of maintenance therapy at Week 52?
Participant snapshot
Who the study is looking for
- The study is looking for children ages 2 through 17.
- The study is looking for participants with Crohn’s disease or fistulizing Crohn’s disease involving active colitis, ileitis, or ileocolitis, confirmed by clinical, endoscopic, and histologic criteria.
- The study is looking for moderately to severely active disease, defined by a baseline Pediatric Crohn’s Disease Activity Index score of at least 30 and specified evidence of active disease on endoscopy.
- The study is looking for participants with a specified history of inadequate response, loss of response, intolerance, corticosteroid dependence, or inadequate response to exclusive enteral nutrition.
Participation overview
What participation may involve
Participants receive weight-based guselkumab during a 12-week open-label induction phase. Their Week 12 response determines whether they enter randomized blinded maintenance with one of two subcutaneous regimens or open-label subcutaneous maintenance. What participation may involve: - Receive weight-based guselkumab intravenously or subcutaneously during the 12-week open-label induction phase. - Have clinical response assessed at Week 12 using the Pediatric Crohn’s Disease Activity Index. - If responding at Week 12, be randomized to one of two blinded, weight-based subcutaneous guselkumab maintenance regimens through Week 48. - If not responding at Week 12, receive open-label, weight-based subcutaneous guselkumab maintenance through Week 48. - Undergo clinical, endoscopic, drug-concentration, growth, patient-reported, and safety assessments at reported study timepoints. Treatment phases are described through Week 48, primary clinical and endoscopic outcomes are assessed at Week 52, and adverse events are monitored up to Week 64.
Study interventions
What participants may receive or do
- Guselkumab: Guselkumab is given by an injection under the skin. The registry describes weight-based subcutaneous treatment during induction or maintenance, depending on the assigned study pathway.
- Guselkumab: Guselkumab is given intravenously, meaning into a vein. One open-label induction group receives weight-based intravenous treatment during the 12-week induction phase.
Study design
How the comparison works
This phase 3 treatment study begins with 12 weeks of open-label, weight-based intravenous or subcutaneous guselkumab. Week 12 responders are randomized between two blinded subcutaneous maintenance regimens, while nonresponders enter open-label subcutaneous maintenance. Participants who respond at Week 12 are randomized to subcutaneous guselkumab dose regimen 1 or dose regimen 2. Week 12 nonresponders are not randomized. The design module reports triple masking of participants, care providers, and investigators, while the maintenance arm labels call that phase double-blind. The record does not explain how these descriptions align. The randomized comparison is between two subcutaneous guselkumab maintenance dose regimens; the record does not identify an active comparator using a different treatment. No placebo arm is listed; every reported study arm receives guselkumab.
Reported activities
Procedures and tests
- Intravenous guselkumab administration during open-label induction for the intravenous group.
- Subcutaneous guselkumab injections during induction or maintenance, depending on the study pathway.
- Pediatric Crohn’s Disease Activity Index assessments for clinical response and remission.
- Endoscopic assessment using the Simplified Endoscopic Score for Crohn’s Disease, including baseline and Week 52 comparisons.
- Serum sampling during induction to measure guselkumab concentration using an immunoassay.
- Pre-dose blood sampling at Weeks 16, 24, 36, 48, and 52 to measure trough guselkumab concentration.
- Body-weight measurements and calculation of weight percentiles and z-scores at baseline and Weeks 12, 24, and 52.
- Height measurements and calculation of height percentiles, z-scores, and height velocity at baseline and Weeks 12, 24, and 52.
- Patient-reported assessment of stool frequency and abdominal pain at Week 12 and/or Week 52.
- Monitoring for adverse events and serious adverse events up to Week 64.
- Screening must confirm a qualifying endoscopy showing active Crohn’s disease within one month before study intervention at Week 0.
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
- A diagnosis of Crohn’s disease or fistulizing Crohn’s disease is required, with active colitis, ileitis, or ileocolitis previously confirmed using clinical, endoscopic, and histologic criteria.
- Baseline disease activity must be moderate to severe, defined as a Pediatric Crohn’s Disease Activity Index score of at least 30.
- Within one month before Week 0 treatment, endoscopy must show active Crohn’s disease with a Simplified Endoscopic Score of at least 6, or at least 4 for isolated ileal disease.
- Participants must meet at least one specified treatment-history pathway: inadequate response, loss of response, or intolerance to listed immunomodulators, corticosteroids, biologic therapy, or a Janus kinase inhibitor; corticosteroid dependence; or inadequate response to exclusive enteral nutrition.
- Participants must be between 2 and 17 years old.
Possible reasons someone may not be able to join
- Participants are excluded for Crohn’s disease complications such as symptomatic strictures or stenosis, short gut syndrome, or another manifestation expected to require surgery.
- Participants must not have an abscess.
- Participants are excluded if they had any bowel resection within 26 weeks before baseline or another intra-abdominal surgery within 12 weeks before baseline.
Important unknowns
What the record does not make clear
- The record lists assessment timepoints but does not provide the number, length, or format of study visits.
- Treatment is described through Week 48, outcomes at Week 52, and adverse-event monitoring through Week 64, but the record does not state each participant’s complete participation period.
- The record does not clearly state which Crohn’s disease medicines or nutritional therapies may continue during the study.
- The record does not provide medication washout requirements or timing rules for prior Crohn’s disease treatments.
- Some outcomes refer to participants who did not receive rescue therapy, but the record does not explain when rescue treatment is available or what it includes.
- The record requires qualifying endoscopy within one month before Week 0 and assesses endoscopic outcomes at Week 52, but it does not provide the complete endoscopy schedule or sedation details.
- The record does not identify which study-related or routine-care costs are covered or billed to insurance.
- The record does not report compensation or reimbursement.
- The record lists study facilities but does not state whether travel or lodging support is available.
- The record does not state whether guselkumab is available to participants after study treatment or follow-up ends.
- The study is recruiting overall, but listed facilities have different statuses, so current availability must be confirmed with a specific site.
- The design module reports triple masking, while the randomized maintenance arm labels describe the phase as double-blind.
Before contacting the site
Questions for the study team
- How is the intravenous versus subcutaneous induction pathway selected?
- What exact guselkumab doses and dosing intervals are used for each weight group and study phase?
- What happens if symptoms worsen or a participant does not respond during induction or maintenance?
- How many endoscopies, blood draws, injections, infusions, and other visits are required?
- Which current Crohn’s disease treatments may continue, and are any washout periods required?
- Which costs are covered, and is assistance available for travel, lodging, meals, or caregiver expenses?
- Is the relevant cohort currently enrolling at our preferred site?
- Who is blinded during maintenance, and what information could be revealed if medical care requires unblinding?
Before changing care
Questions for your gastroenterologist
- How stable is the child’s Crohn’s disease now, and what risks could come from changing or pausing current treatment for screening or study participation?
- How does guselkumab in this study compare with approved treatment alternatives appropriate for this child’s age, disease location, severity, and prior treatment history?
- Are the required endoscopies, blood sampling, and intravenous or subcutaneous dosing reasonable in this child’s clinical situation?
- How should the gastroenterology and research teams coordinate routine care, flare management, rescue treatment, and interpretation of study assessments?
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
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
Study design and administration
- Organization
- Janssen Research & Development, LLC
- Organization class
- Industry
- Organization study ID
- CR109212
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Triple
- Who is masked
- Participant, Care Provider, Investigator
- Standard age groups
- Child
Study arms
Experimental
Open-label induction phase: Guselkumab Intravenously (IV)
Participants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.
Interventions: Drug: Guselkumab
Experimental
Open-label induction phase: Guselkumab Subcutaneously (SC)
Participants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.
Interventions: Drug: Guselkumab
Experimental
Double-blind maintenance phase: Guselkumab SC Dose Regimen 1
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their body weight up to Week 48.
Interventions: Drug: Guselkumab
Experimental
Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their body weight up to Week 48.
Interventions: Drug: Guselkumab
Experimental
Open-label maintenance phase: Guselkumab SC
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.
Interventions: Drug: Guselkumab
Interventions
Drug
Guselkumab
Guselkumab will be administered subcutaneously.
Drug
Guselkumab
Guselkumab will be administered intravenously.
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (4)
- Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.Registry-derived · unreviewed
- Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \[PCDAI\] score greater than or equal to \[\>=\] 30)Registry-derived · unreviewed
- Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (\>=) 6 (or \>=4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0Registry-derived · unreviewed
- Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)Registry-derived · unreviewed
Exclusion criteria (3)
- Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.Registry-derived · unreviewed
- Participants must not have an abscessRegistry-derived · unreviewed
- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baselineRegistry-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
Percentage of Participants with Clinical Remission at Week 52
Time frame: Week 52
Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (\<=) 10.
Primary outcome
Percentage of Participants Who Achieve Endoscopic Response at Week 52
Time frame: Week 52
Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (\>=) 50 percent (%) reduction (global) and greater than (\>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.
Secondary outcome
Percentage of Participants with Clinical Response at Week 12
Time frame: Week 12
Percentage of participants with clinical response at Week 12 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of \>=12.5 points with a total PCDAI score \<30.
Secondary outcome
Percentage of Participants with Clinical Response at Week 52
Time frame: Week 52
Percentage of participants with clinical response at Week 52 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of \>=12.5 points with a total PCDAI score \<30.
Secondary outcome
Percentage of Participants with Clinical Remission at Week 12
Time frame: Week 12
Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as PCDAI score \<=10.
Secondary outcome
Percentage of Participants with Endoscopic Remission at Week 52
Time frame: Week 52
Percentage of participants with endoscopic remission at Week 52 will be assessed. Endoscopic remission is defined as SES-CD total score \<=4 and at least a 2-point reduction from baseline and no subscore \>1.
Secondary outcome
Percentage of Participants with Corticosteroid-free Remission at Week 52
Time frame: Week 52
Percentage of participants with corticosteroid-free remission at Week 52 will be assessed. Corticosteroid-free remission is defined as PCDAI score \<=10 at Week 52 and not receiving corticosteroids for at least 90 days before Week 52.
Secondary outcome
Percentage of Participants with Sustained Clinical Remission at Weeks 12, 24, and 52
Time frame: Weeks 12, 24, and 52
Percentage of participants with sustained clinical remission at Weeks 12, 24, and 52 will be assessed. Sustained clinical remission is defined as PCDAI \<=10 at Weeks 12, 24, and 52.
Secondary outcome
Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2)
Time frame: Week 12 and/or Week 52
Percentage of participants with clinical remission by PRO-2 will be assessed. Clinical remission by PRO-2 is defined as stool frequency (SF) \<=3 and abdominal pain (AP) \<=1 and no worsening of SF and AP from baseline.
Secondary outcome
Serum Concentration of Guselkumab During Induction Phase
Time frame: From Week 0 to Week 12
Serum concentrations of guselkumab will be assessed. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive immunoassay method.
Secondary outcome
Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase
Time frame: At Weeks 16, 24, 36, 48 and 52
Ctrough is defined as the serum concentration of guselkumab immediately prior (pre-dose) to the next drug administration.
Secondary outcome
Change from Baseline in Body Weight at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Change from baseline in body weight at Weeks 12, 24, and 52 will be assessed.
Secondary outcome
Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Change from baseline in body weight percentiles at Weeks 12, 24, and 52 will be assessed.
Secondary outcome
Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Change from baseline in body weight z-scores at Weeks 12, 24, and 52 will be assessed.
Secondary outcome
Change from Baseline in Height at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Change from baseline in height at Weeks 12, 24, and 52 will be assessed.
Secondary outcome
Change from Baseline in Height Percentiles at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Change from baseline in height percentiles at Weeks 12, 24, and 52 will be assessed.
Secondary outcome
Change from Baseline in Height z-scores at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Change from baseline in height z-scores at Weeks 12, 24, and 52 will be assessed.
Secondary outcome
Change from Baseline in Height Velocity at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Change from baseline in height velocity at Weeks 12, 24, and 52 will be assessed.
Secondary outcome
Percentage of Participants with Clinical Remission
Time frame: Week 52
Percentage of participants with clinical remission who were assigned to guselkumab dose regimen 1 and did not receive rescue therapy at Week 52 will be assessed. Clinical remission is defined as PCDAI score \<=10.
Secondary outcome
Percentage of Participants Who Achieve Endoscopic Response
Time frame: Week 52
Percentage of participants who achieve endoscopic response who were assigned to q4w maintenance therapy and did not receive rescue therapy at Week 52 will be assessed. Endoscopic response is defined as \>=50% reduction (global) and \>50% reduction (U.S specific) from SES-CD score at baseline.
Secondary outcome
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 64
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Recruiting locations in the United States
Cedars Sinai Medical Center
RecruitingLos Angeles, California, 90048, United States
Connecticut Children's Medical Center
RecruitingHartford, Connecticut, 06106, United States
Children's Center for Digestive Health Care
RecruitingAtlanta, Georgia, 30342, United States
Riley Hospital for Children
RecruitingIndianapolis, Indiana, 46202-5225, United States
Boston Childrens Hospital
RecruitingBoston, Massachusetts, 02115, United States
Goryeb Children's Hospital
RecruitingMorristown, New Jersey, 07960, United States
Columbia University Medical Center
RecruitingNew York, New York, 10032, United States
Icahn School of Medicine at Mount Sinai
RecruitingNew York, New York, 10029, United States
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center
RecruitingNew York, New York, 10021-5663, United States
Children's Hospital of Philadelphia
RecruitingPhiladelphia, Pennsylvania, 19104, United States
Cook Childrens Medical Center
RecruitingFort Worth, Texas, 76104, United States
University of Vermont Medical Center
RecruitingColchester, Vermont, 05446, United States
This study also lists 71 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Jun 28, 2023
- Primary completion
- Oct 27, 2027
- Overall completion
- Jul 12, 2028
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.