Printed from Voxsanity (voxsanity.com.au) — NCT07353450 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Early Phase 1 Crohn's Disease and Colitis Trial, Not Yet Recruiting
NCT07353450
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
- People who are between 18 and 75 years old at the time of signing the consent form
- People who have been diagnosed with ulcerative colitis (UC)
- People who currently have active moderate to severe ulcerative colitis
- People whose ulcerative colitis extends beyond just the rectum into other parts of the colon
- People who have tried at least one biologic or other advanced treatment for UC and either did not respond well enough or could not tolerate it
- People who have been on a stable background medication (or combination of medications) up to the start of the study
- People who have had a recent bowel cancer surveillance colonoscopy within the last 12 months (required for those with extensive colitis lasting more than 8 years, left-sided colitis lasting more than 12 years, or a condition called primary sclerosing cholangitis), OR who have up-to-date bowel cancer surveillance if they have a family history of bowel cancer, a personal history of increased bowel cancer risk, are over 50 years old, or have other known risk factors (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.
- People whose blood or laboratory test results fall outside acceptable ranges at the screening stage
- People who have other gastrointestinal diseases
- People who have an active infection at the time of screening
- People who are currently receiving, or are unable to stop taking, certain medications that are not permitted under the study rules
- People who have received a live vaccine within the 4 weeks before screening
- People with a history of a rare and serious brain condition called progressive multifocal leukoencephalopathy
- People with a history of a primary immune system deficiency or an inherited deficiency of the complement system (a part of the immune system)
- People who have a disease affecting the central nervous system (brain or spinal cord)
- People who have one or more significant other medical conditions, as determined by the study doctor
- People who have been diagnosed with or treated for cancer within the 5 years before screening
- People with a history of a condition called plasma cell dyscrasia (a disease affecting certain immune cells)
- People who need to take blood-thinning medication continuously without interruption
- People with serious mental illness, alcohol or drug dependence, dementia, or any other condition that would affect their ability to receive treatment or understand the consent process, as assessed according to local practice
- People who would be unable to follow the requirements set out in the study protocol
- People who have had a severe allergic or anaphylactic reaction to a type of medicine called a monoclonal antibody, or to any ingredient in the study drug (cizutamig)
- People who have had a severe allergic or anaphylactic reaction, or intolerance, to certain antibiotic or antimicrobial medicines required as part of the study
- People who have had, or are planning to have, an organ transplant or stem cell transplant, or who have had a corneal (eye) transplant within 12 weeks before screening
- People who have had major surgery requiring general anaesthetic within 12 weeks before screening, or who are expected to need major surgery during the study
- People who have had their spleen removed or who have a spleen that does not function properly
- People who have any serious medical condition or abnormal laboratory test result
- People who are unable to follow the contraception requirements set out in the study protocol
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.
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.
Contact this trial
Phone: 13901617608
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.
Trial details
Status
Not Yet Recruiting
Phase
Early Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
1 January 2026
Est. completion
1 December 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Safety and tolerability
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 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.