Phase 3 Crohn's Disease and Colitis Trial, RecruitingNCT06819878Sponsor: Hoffmann-La RocheCondition: Crohn's Disease and Colitis
Printed from Voxsanity (voxsanity.com.au) — NCT06819878 — 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
NCT06819878
RecruitingPhase 3🇦🇺 Australian site
Who may 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 might be able to join this trial:
You have a confirmed diagnosis of Crohn's disease (CD)
Your Crohn's disease is considered moderately to severely active
You weigh at least 40 kilograms (about 88 pounds)
You have tried at least one standard or advanced Crohn's disease treatment but it did not work well enough, stopped working, or you could not tolerate it
If you are male or female and able to have children, you must agree to follow the trial's specific birth control requirements
Who may not be able to join:
You have been diagnosed with ulcerative colitis, indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis (a different type of bowel condition)
You have had 3 or more bowel removal surgeries where more than 2 sections of your bowel were removed
You have been diagnosed with short bowel syndrome (a condition where much of the small intestine is missing or not working)
You currently have an ileostomy, colostomy, or an ileoanal pouch (surgically created openings or pouches related to your bowel)
You have painful or dangerous bowel blockages, severe colitis, or a life-threatening condition called toxic megacolon
You currently have an abscess (a pocket of infection) in your abdomen or around your back passage
You have certain types of abnormal connections (fistulas) between your bowel and other organs, or fistulas around your back passage with more than 3 openings
You have or are suspected to have a liver condition called primary sclerosing cholangitis
You are currently pregnant, breastfeeding, or planning to become pregnant during the study
You have a current or past diagnosis of cancer in your digestive tract, or certain pre-cancerous changes in your colon
You have a history of cancer outside the digestive tract, except for certain treated skin cancers or treated early-stage cervical cancer
You have shown signs of infection with C. difficile, cytomegalovirus (CMV), HIV, Hepatitis B, or Hepatitis C during the screening process
You have active tuberculosis (TB), untreated latent TB, or TB that has not been properly treated
You have previously received or are currently taking a type of medication called anti-TL1A therapy, or other medicines listed as prohibited in the trial (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.
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 19 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Clinical Trials, Hoffmann-La Roche
The Canberra Hospital, Garran, Australian Capital Territory
Royal Prince Alfred Hospital, Sydney, New South Wales
Royal Brisbane and Women's Hospital, Herston, Queensland
Mater Misericordiae Limited, South Brisbane, Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland
Flinders Medical Center, Adelaide, South Australia
Lyell McEwin Hospital, Adelaide, South Australia
Northern Hospital, Epping, Victoria
Fiona Stanley Hospital, Murdoch, Western Australia
Royal Perth Hospital, Perth, Western Australia
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: NCT06819878
Sponsor: Hoffmann-La Roche
Phase: Phase 3
Status: Recruiting
Condition: Crohn's Disease and Colitis
Trial contact: 888-662-6728 (U.S. and Canada)
More information: https://clinicaltrials.gov/study/NCT06819878
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
You have a confirmed diagnosis of Crohn's disease (CD)
Your Crohn's disease is considered moderately to severely active
You weigh at least 40 kilograms (about 88 pounds)
You have tried at least one standard or advanced Crohn's disease treatment but it did not work well enough, stopped working, or you could not tolerate it
If you are male or female and able to have children, you must agree to follow the trial's specific birth control requirements
Who may not be able to join:
You have been diagnosed with ulcerative colitis, indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis (a different type of bowel condition)
You have had 3 or more bowel removal surgeries where more than 2 sections of your bowel were removed
You have been diagnosed with short bowel syndrome (a condition where much of the small intestine is missing or not working)
You currently have an ileostomy, colostomy, or an ileoanal pouch (surgically created openings or pouches related to your bowel)
You have painful or dangerous bowel blockages, severe colitis, or a life-threatening condition called toxic megacolon
You currently have an abscess (a pocket of infection) in your abdomen or around your back passage
You have certain types of abnormal connections (fistulas) between your bowel and other organs, or fistulas around your back passage with more than 3 openings
You have or are suspected to have a liver condition called primary sclerosing cholangitis
You are currently pregnant, breastfeeding, or planning to become pregnant during the study
You have a current or past diagnosis of cancer in your digestive tract, or certain pre-cancerous changes in your colon
You have a history of cancer outside the digestive tract, except for certain treated skin cancers or treated early-stage cervical cancer
You have shown signs of infection with C. difficile, cytomegalovirus (CMV), HIV, Hepatitis B, or Hepatitis C during the screening process
You have active tuberculosis (TB), untreated latent TB, or TB that has not been properly treated
You have previously received or are currently taking a type of medication called anti-TL1A therapy, or other medicines listed as prohibited in the trial (confirm with trial site)
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 19 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇷 Brazil
🇧🇬 Bulgaria
🇨🇦 Canada
🇨🇱 Chile
🇨🇳 China
🇨🇴 Colombia
🇭🇷 Croatia
🇨🇿 Czechia
🇩🇰 Denmark
Dominican Republic
🇫🇷 France
🇩🇪 Germany
Guatemala
🇭🇺 Hungary
🇮🇳 India
🇮🇱 Israel
🇮🇹 Italy
🇯🇵 Japan
🇲🇽 Mexico
🇳🇱 Netherlands
Panama
🇵🇱 Poland
🇵🇹 Portugal
Puerto Rico
🇷🇴 Romania
🇷🇸 Serbia
🇸🇰 Slovakia
🇰🇷 South Korea
🇪🇸 Spain
🇹🇼 Taiwan
🇹🇭 Thailand
🇦🇪 United Arab Emirates
🇬🇧 United Kingdom
🇺🇸 United States
10 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score; Percentage of Participants with Endoscopic Response
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: 19 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.