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NCT06663332

NCT06663332
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must have already completed all planned doses in the original pediatric guselkumab study.
  • The study doctor must believe that you are still benefiting from continuing guselkumab treatment.
  • If you are able to have children, you must either not be sexually active, be practicing abstinence, or be using a highly effective form of birth control — and agree to continue doing so during the study and for 12 weeks after the last dose.
  • A parent or legal guardian must sign a consent form showing they understand the study and agree to allow their child to take part.
  • Children who are old enough to understand the study (usually age 7 and older) must also agree to participate, and teenagers who agreed to join will be asked to sign an adult consent form when they reach adulthood.

Who may not be able to join:

  • You are 18 or older and live in a country where this medication has been approved for adults for more than 2 years.
  • You are under 18 and live in a country where this medication has been approved for children for more than 2 years.
  • You are currently pregnant, breastfeeding, planning to become pregnant, or planning to father a child.
  • You have used any treatments that are not allowed by the study before receiving your first dose in this extension study.
  • You or a close family member work for the study doctor or study site and are directly involved in running this or related studies.
  • The study doctor believes, for any reason, that joining the study would not be in your best interest or could interfere with how the study is carried out (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Janssen Research & Development, LLC
Registry
clinicaltrials_gov
Start date
29 October 2024
Est. completion
12 December 2031

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇵🇹 Portugal 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov