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NCT03466411

NCT03466411
Active, Not Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Crohn's disease (including a form that causes tunnels or passages called fistulas) for at least 3 months, affecting your colon, small intestine, or both, confirmed at some point by imaging, tissue samples, or a camera procedure
  • Your Crohn's disease is considered moderate to severe, based on scores measuring symptoms like stool frequency, abdominal pain, and the appearance of your intestines during a camera examination
  • Your blood or lab test results from the screening stage fall within the acceptable ranges set by the study
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the study
  • You have either not responded well enough to standard Crohn's disease treatments or biologic medicines, or you were unable to tolerate them

Who may not be able to join:

  • You have been diagnosed with ulcerative colitis or a form of colitis that doctors have not been able to clearly classify
  • You have serious complications from Crohn's disease, such as significant narrowing of the intestine, short gut syndrome, or other related complications
  • Your current Crohn's disease medications have not been at a stable dose recently
  • You have recently received certain approved biologic treatments, experimental treatments, or procedures outside of the timeframes allowed by the study rules
  • You have other health conditions that would make it unsafe for you to take part in the study (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
Active, Not Recruiting
Phase
Phase 3
Sponsor
Janssen Research & Development, LLC
Registry
clinicaltrials_gov
Start date
13 April 2018
Est. completion
20 October 2023

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria Belarus 🇧🇪 Belgium Bosnia and Herzegovina 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇯🇴 Jordan 🇱🇻 Latvia 🇱🇧 Lebanon 🇱🇹 Lithuania 🇲🇾 Malaysia 🇳🇱 Netherlands 🇳🇿 New Zealand North Macedonia 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇺 Russia 🇸🇦 Saudi Arabia 🇷🇸 Serbia 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Tunisia Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12; Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48; Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48; Global: GALAXI 3: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48; Global: GALAXI 3: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48; Regional...

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