A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease
Study Evaluates Guselkumab for Pediatric Crohn's Disease
Plain English Summary
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease is a Phase 3 clinical trial sponsored by Janssen Research & Development, LLC studying Crohn's Disease. Tests guselkumab's effectiveness in maintaining remission in children with Crohn's Disease. For children aged 6 to 17 with active Crohn's Disease who have responded to guselkumab. Participation involves receiving guselkumab injections and regular check-ups. Alternative treatments include other biologics, immunomodulators, and corticosteroids. The trial aims to enroll 120 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible participants are children aged 6 to 17 with active Crohn's Disease. Must have a PCDAI score of at least 30 and active CD on endoscopy. Cannot have complications like strictures or surgery within certain time frames. Cannot have an abscess or bowel resection within specified periods. This trial is studying Crohn's Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how well guselkumab keeps symptoms at bay and improves endoscopic signs of disease. The specific primary outcome measures are: Percentage of Participants with Clinical Remission at Week 52 (Week 52); Percentage of Participants Who Achieve Endoscopic Response at Week 52 (Week 52). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to fill the gap in treatment options for pediatric Crohn's Disease, offering a new way to maintain remission. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Crohn's Disease, where improved treatment options are needed.
Investor Insight
The large market size and competitive landscape suggest a high probability of approval for this innovative treatment. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you or your child qualifies for the study. Participation involves regular clinic visits and guselkumab injections. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: TRIPLE
- Enrollment: 120 participants
Interventions
- DRUG: Guselkumab — Guselkumab will be administered subcutaneously.
- DRUG: Guselkumab — Guselkumab will be administered intravenously.
Primary Outcomes
- Percentage of Participants with Clinical Remission at Week 52 (Week 52)
- Percentage of Participants Who Achieve Endoscopic Response at Week 52 (Week 52)
Secondary Outcomes
- Percentage of Participants with Clinical Response at Week 12 (Week 12)
- Percentage of Participants with Clinical Response at Week 52 (Week 52)
- Percentage of Participants with Clinical Remission at Week 12 (Week 12)
- Percentage of Participants with Endoscopic Remission at Week 52 (Week 52)
- Percentage of Participants with Corticosteroid-free Remission at Week 52 (Week 52)
Full Eligibility Criteria
Inclusion Criteria: * 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. * 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) * 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 0 * 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) Exclusion Criteria: * 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. * Participants must not have an abscess * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline
Trial Locations
- Cedars Sinai Medical Center, Los Angeles, California, United States
- Connecticut Children's Medical Center, Hartford, Connecticut, United States
- Emory University, Atlanta, Georgia, United States
- Children's Center for Digestive Health Care, Atlanta, Georgia, United States
- Riley Hospital for Children, Indianapolis, Indiana, United States
- Boston Childrens Hospital, Boston, Massachusetts, United States
- Goryeb Children's Hospital, Morristown, New Jersey, United States
- Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center, New York, New York, United States
- Icahn School of Medicine at Mount Sinai, New York, New York, United States
- Columbia University Medical Center, New York, New York, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05923073?
NCT05923073 is a Phase 3 INTERVENTIONAL study titled "A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease." It is currently recruiting and is sponsored by Janssen Research & Development, LLC. The trial targets enrollment of 120 participants.
What conditions does NCT05923073 study?
This trial investigates treatments for Crohn's Disease. The primary condition under study is Crohn's Disease.
What treatments are being tested in NCT05923073?
The interventions being studied include: Guselkumab (DRUG), Guselkumab (DRUG). Guselkumab will be administered subcutaneously.
What does Phase 3 mean for NCT05923073?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT05923073?
This trial is currently "Recruiting." It started on 2024-03-13. The estimated completion date is 2028-07-12.
Who is sponsoring NCT05923073?
NCT05923073 is sponsored by Janssen Research & Development, LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05923073?
The trial aims to enroll 120 participants. The trial is currently recruiting and accepting new participants.
How is NCT05923073 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05923073?
The primary outcome measures are: Percentage of Participants with Clinical Remission at Week 52 (Week 52); Percentage of Participants Who Achieve Endoscopic Response at Week 52 (Week 52). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05923073 being conducted?
This trial is being conducted at 20 sites, including Los Angeles, California; Hartford, Connecticut; Atlanta, Georgia; Indianapolis, Indiana and 16 more sites (United States, Australia, Austria).
Where can I find official information about NCT05923073?
The official record for NCT05923073 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05923073. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05923073 testing in simple terms?
Tests guselkumab's effectiveness in maintaining remission in children with Crohn's Disease. For children aged 6 to 17 with active Crohn's Disease who have responded to guselkumab.
Why is this trial significant?
This trial aims to fill the gap in treatment options for pediatric Crohn's Disease, offering a new way to maintain remission. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT05923073?
Potential side effects include injection site reactions and increased risk of infections. Monitor for any unusual symptoms and report them to your healthcare provider. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05923073?
Ask your doctor if you or your child qualifies for the study. Participation involves regular clinic visits and guselkumab injections. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05923073 signal from an investment perspective?
The large market size and competitive landscape suggest a high probability of approval for this innovative treatment. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves receiving guselkumab injections and regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.