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NCT06663332 · ClinicalTrials.gov registry record · Phase 3

A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants

A Phase 3 study of Crohn's Disease and Colitis, Ulcerative, sponsored by Janssen Research & Development.

Recruiting
Registry status
Phase 3
Development phase
196
Enrollment target
20
Study locations

NCT06663332 is a Phase 3 study of Crohn's Disease and Colitis, Ulcerative that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 196 participants, below the 2,413-participant average among 104 other Crohn's Disease trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT06663332, a Phase 3 study of Crohn's Disease and Colitis, Ulcerative, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
Phase 3
Development phase
196 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

Interventions

  • DRUG Guselkumab

Study Locations (20)

Other

  • Instituto Caici - Rosario
  • Capital Center For Children's health Capital Medical University - Beijing
  • Changzhou No 2 Peoples Hospital - Changzhou
  • The Childrens Hospital Zhejiang University School Of Medicine - Hangzhou
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Hangzhou
  • Ruijin Hospital Shanghai Jiao Tong University - Shanghai
  • Shengjing Hospital Of China Medical University - Shenyang
  • Hospital Center University De Lille - Lille
  • Schon Klinik Hamburg Eilbek - Hamburg
  • ASST Papa Giovanni XXIII Bergamo - Bergamo
  • Azienda USL di Bologna - Ospedale Maggiore - Bologna
  • Kanazawa University Hospital - Kanazawa
  • Kobe University Hospital - Kobe
  • Japanese Red Cross Kumamoto Hospital - Kumamoto
  • Shinshu University Hospital - Matsumoto
  • Saga University Hospital - Saga

Georgia

  • Emory University - Atlanta

Indiana

  • Riley Hospital for Children - Indianapolis

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2024-10-29
Est. Completion 2031-12-12
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT06663332

The ClinicalTrials.gov registry entry for NCT06663332 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,413-participant average among 104 other Crohn's Disease trials with a reported enrollment target (92% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Guselkumab is the first listed.

NCT06663332 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, Georgia, Indiana.

Frequently Asked Questions

What is clinical trial NCT06663332 about?

NCT06663332 is a clinical study titled "A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants". The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).

What is the current status of trial NCT06663332?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2024-10-29. Estimated completion is 2031-12-12.

What conditions does trial NCT06663332 study?

This clinical trial studies the following conditions: Crohn's Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile.

What interventions are being tested in trial NCT06663332?

The interventions under investigation include: Guselkumab (DRUG).

Who is sponsoring clinical trial NCT06663332?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06663332 being conducted?

This trial has 20 study locations across Georgia, Indiana, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.