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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT04877990

NCT04877990
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must have already taken part in and completed a previous related study (called a "parent study") for Crohn's disease or ulcerative colitis, where the treatment was given in an open, non-blinded way.

Who may not be able to join:

  • Women who are currently pregnant or breastfeeding.
  • People who have been found to have abnormal or pre-cancerous growths in the colon (polyps or abnormal cell changes), either found during the final examination of the previous related study, or found during that study and not yet fully treated or removed.

Important: There may be additional criteria not listed here that could affect your eligibility — 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 2: approximately ~30% 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
Completed
Phase
Phase 2
Sponsor
Bristol-Myers Squibb
Registry
clinicaltrials_gov
Start date
7 May 2021
Est. completion
29 August 2023

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

1 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 (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs); Number of Participants With Laboratory Abnormalities; Number of Participants With Electrocardiogram (ECG) Abnormalities; Number of Participants With Vital Signs Abnormalities; Change From Baseline in Laboratory Parameters; Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate; Change From Baseline in Electrocardiogram (ECG) Parameters; Change From Baseline in Vital Signs Parameters - Heart Rate; Change From Baseline in Vital Signs Parameters

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