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NCT06430801

NCT06430801
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 (CD) for at least 3 months before joining the study.
  • Your Crohn's disease is considered moderately to severely active.
  • Previous treatments have not worked well enough for you, stopped working, or caused side effects you could not tolerate — this includes steroids, immune-suppressing medications, or more advanced biologic or small molecule therapies.
  • Teenagers aged 16 or 17 may be able to join, depending on approval in their country (confirm with trial site).

Who may not be able to join:

  • You have been diagnosed with ulcerative colitis or indeterminate colitis instead of Crohn's disease.
  • Your Crohn's disease only affects certain parts of the upper digestive tract or the area around the anus, without involving the large intestine or lower small intestine.
  • You currently have serious complications of Crohn's disease, such as an abscess, a severe narrowing of the bowel, a severely inflamed colon, or a condition that may require surgery soon.
  • You currently have or need a stoma bag (colostomy or ileostomy).
  • Large portions of your bowel are missing (more than 2 out of 5 specific sections of your intestine).
  • You have been diagnosed with short bowel syndrome or have another unrelated condition causing ongoing, uncontrolled diarrhea.
  • You have had bowel surgery within the 3 months before joining the study.
  • You have a history of abnormal or pre-cancerous cell changes in your digestive tract.
  • You have a long-term infection that requires ongoing antibiotic or antimicrobial treatment.
  • You have had cancer in the past or currently, unless it was a certain type of treatable skin cancer or a very early-stage cervical condition that was fully removed — and you must have been cancer-free for at least 5 years.
  • You are currently infected with Hepatitis B, Hepatitis C, or HIV.
  • You have active tuberculosis (TB).
  • You currently have or are suspected to have COVID-19.
  • You have previously received the specific experimental drug being tested in this trial (tulisokibart/MK-7240/PRA023) or a similar type of drug.

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
Merck Sharp & Dohme LLC
Registry
clinicaltrials_gov
Start date
5 June 2024
Est. completion
30 October 2028

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark Dominican Republic 🇫🇮 Finland 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇪 Peru 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇦 Saudi Arabia 🇷🇸 Serbia 🇸🇬 Singapore 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52; Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52; Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52; Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12; Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12; Study 1: Percentage of Participan...

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