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Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting
NCT06867042
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
- Adults aged 18 to 65 years (male or female).
- People with a confirmed diagnosis of ulcerative colitis (based on colonoscopy and tissue examination) that affects the left side of the colon, with mild to moderate active disease.
- People whose disease scores at least 4 on a standard activity scale (called the modified Mayo Score), including specific minimum scores for bowel lining inflammation and rectal bleeding.
- People who have not responded well to, lost response to, or could not tolerate at least one standard medication such as aminosalicylates (e.g., mesalamine, sulfasalazine), steroids, azathioprine, mercaptopurine, or methotrexate, and whose doctor considers an alternative treatment necessary.
- People who did not achieve full symptom relief after completing at least one full course of standard treatments (aminosalicylates, steroids, azathioprine, mercaptopurine, or methotrexate) over a minimum of 4 weeks, and whose doctor considers an alternative necessary.
- People who have previously used biologic medicines (such as anti-TNF, anti-integrin, or anti-interleukin treatments) for ulcerative colitis without sufficient benefit may be considered, provided enough time has passed since stopping that treatment (generally five times the medicine's half-life, or a shorter period if blood tests confirm the medicine is no longer detectable) (confirm with trial site).
- Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or who agree to use a highly effective form of contraception during the study and for at least 6 weeks after the last dose.
- Women of childbearing potential must have a negative blood pregnancy test at the screening visit and a negative urine pregnancy test before the first dose.
- Men who agree not to donate sperm during the study and for at least 6 weeks after the last dose, and who either abstain from sexual activity that could result in pregnancy or agree to use a condom; male participants are also advised that their female partner using additional contraception is recommended.
- People who are able to understand and sign a written consent form before any study procedures begin.
- People with acceptable blood test results for general health, blood counts, liver function, and kidney function at the screening visit.
- People who have stopped aminosalicylates or steroids at least 2 weeks before the baseline colonoscopy, or stopped azathioprine, mercaptopurine, or methotrexate at least 8 weeks before the baseline colonoscopy.
- For a smaller group of 30 participants taking part in a detailed drug-level (pharmacokinetic) sub-study: people who agree to additional blood sampling and who have suitable vein access for blood draws.
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 ulcerative colitis affects the entire colon (pan-colitis) or the upper/right portions of the colon.
- People with a modified Mayo Score of 8 or higher, indicating severe disease.
- People with a known allergy to the study medicines or who have had a serious reaction to them in the past.
- People showing signs of very severe colitis complications, such as toxic megacolon, bowel narrowing, a potential need for a blood transfusion due to gut bleeding, or signs of infection spreading in the abdomen.
- People with a documented history of high-grade abnormal cell changes (dysplasia) found during a previous colonoscopy biopsy.
- People with active gut infection, including infection with Clostridium difficile bacteria, detected in stool samples.
- People with a history of repeated Clostridium difficile infections.
- People who have received systemic (whole-body) steroids or immune-suppressing medicines within the 4 weeks before screening.
- People who received antibiotic, antifungal, or antiparasitic medicines during the screening period.
- People with a history of cancer, asthma, or bronchospasm (airway tightening).
- People who cannot stop taking immune-suppressing medicines (such as sirolimus or cyclosporine) for the duration of the study.
- People with high potassium levels in their blood (hyperkalemia).
- People who are pregnant or currently breastfeeding.
- People with a history of substance abuse.
- People who have a history of being unable to retain enemas.
- People diagnosed with Crohn's disease.
- People with HIV, Hepatitis B, or Hepatitis C infection.
- People currently taking potassium-sparing diuretic medicines (a type of fluid tablet).
- People with pre-existing kidney disease, liver disease, heart disease, high blood pressure, or significant blood, metabolic, psychiatric, neurological, or lung conditions.
- People who took part in any other clinical trial or post-marketing study (including medical devices) within 30 days before signing the consent form.
- People with any other condition that the investigating doctor considers would make participation unsafe or affect the study results.
- People with uncontrolled high blood pressure (systolic of 140 mmHg or higher, or diastolic of 90 mmHg or higher) despite being on appropriate blood pressure treatment at screening.
- People with severe liver impairment classified as Child-Pugh Class C (a medical measure of liver disease severity).
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Jina Pharmaceuticals Inc.
Registry
ClinicalTrials.gov
Start date
1 April 2025
Est. completion
1 December 2025
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Proportion of patients in clinical remission
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.