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NCT06408935 · ClinicalTrials.gov registry record · Phase 3
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
A Phase 3 study of Crohn's Disease, sponsored by Janssen-Cilag.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
- 20
- Study locations
NCT06408935: Recruiting Phase 3 study of Crohn's Disease, sponsored by Janssen-Cilag.
NCT06408935 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Janssen-Cilag. The registered enrollment target is 112 participants, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06408935, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Janssen-Cilag.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.
Primary Outcome
Percentage of participants achieving a MaRIA \<11 in all intestinal segments at Week 48 will be reported. The MaRIA scoring system is used to grade severity in Crohn's Disease (CD) by assessing ileocolonic CD activity on contrast-enhanced magnetic resonance imaging (MRI) enterography. Active disease is defined as a MaRIA score greater than or equal to (\>=)7 whereas severe disease is defined as a MaRIA score \>=11.
Conditions Studied
Interventions
- DRUG Guselkumab
Study Locations (20)
Other
- The Queen Elizabeth Hospital - Adelaide
- Concord Repatriation General Hospital - Concord
- Northern Hospital - Melbourne
- Fiona Stanley Hospital - Murdoch
- Mater Hospital Brisbane - South Brisbane
- AZ Maria Middelares - Ghent
- CHU de Liege - Liège
- Vitaz - Sint-Niklaas
- Cliged - Macaé
- Instituto Mederi de Pesquisa e Saude - Passo Fundo
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul - Porto Alegre
- INTEGRAL Pesquisa e Ensino - Votuporanga
- Nemocnice Ceske Budejovice a s - České Budějovice
California
- Center for Colitis and Crohns Disease University of California - San Francisco
Illinois
- The University of Chicago Medical Center (UCMC) - Chicago
Missouri
- Washington University School Of Medicine - St Louis
South Carolina
- Medical University of South Carolina - Charleston
Alberta
- Foothills Hospital - Calgary
Ontario
- Western University & London Health Sciences Centre - London
Quebec
- Hopital du Sacre-Coeur de Montreal - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2028-03-06 |
| Phase | Phase 3 |
What NCT06408935 shows while recruiting
NCT06408935 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Guselkumab is the first listed.
NCT06408935 names 20 study sites across 8 states, led by Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06408935 about?
NCT06408935 is a clinical study titled "Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients". The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.
What is the current status of trial NCT06408935?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2024-04-17. Estimated completion is 2028-03-06.
What conditions does trial NCT06408935 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT06408935?
The interventions under investigation include: Guselkumab (DRUG).
Who is sponsoring clinical trial NCT06408935?
This trial is sponsored by Janssen-Cilag, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06408935 being conducted?
This trial has 20 study locations across California, Illinois, Missouri, South Carolina, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06408935's enrollment target sits among peer trials
112 65th of 105 higher than 41 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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