Phase 3 Crohn's Disease and Colitis Trial, RecruitingNCT06430801Sponsor: Merck Sharp & Dohme LLCCondition: Crohn's Disease and Colitis
Printed from Voxsanity (voxsanity.com.au) — NCT06430801 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Phase 3 Crohn's Disease and Colitis Trial, Recruiting
NCT06430801
RecruitingPhase 3🇦🇺 Australian site
voxsanity.com.au ·
Eligibility summary from public government registries ·
18 August 2026 ·
not medical advice
Who may and may not be able to join
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who may be able to join
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
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Contact this trial
Principal Investigator: Medical Director, Merck Sharp & Dohme LLC
Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 3202), Concord, New South Wales
+61 2 9767 5000
Royal Brisbane and Women's Hospital ( Site 3200), Brisbane, Queensland
+61736468401
Mater Misericordiae Limited ( Site 3209), Brisbane, Queensland
+61731638195
Royal Adelaide Hosp - GI Clinical Trials ( Site 3203), Adelaide, South Australia
+61 8 7074 2200
Monash Health-Gastroenterology ( Site 3206), Clayton, Victoria
+61(0)395943577
The Alfred Hospital-Gastroenterology ( Site 3201), Melbourne, Victoria
+61(0)390760182
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT06430801
Sponsor: Merck Sharp & Dohme LLC
Phase: Phase 3
Status: Recruiting
Condition: Crohn's Disease and Colitis
Trial contact: 1-888-577-8839
More information: https://clinicaltrials.gov/study/NCT06430801
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who may be able to join
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
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
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.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 23 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇺 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.
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.
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