Printed from Voxsanity (voxsanity.com.au) — NCT07700446 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Crohn's Disease and Colitis Trial, Not Yet Recruiting
NCT07700446
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 willing to sign and date a consent form that has been approved by an ethics review board, before any study-related checks begin.
- People who are aged 18 years or older and under 65 years old.
- People whose recent blood test results meet all of the following levels (confirm with trial site for exact values): liver enzyme ALT below 2 times the upper limit of normal; liver enzyme AST below 2 times the upper limit of normal; kidney filtration rate above 0 mL/min/1.73 m²; total white blood cell count above 2,500 per microlitre; neutrophil count above 1,500 per microlitre; platelet count above 100,000 per microlitre; lymphocyte count above 850 per microlitre; and haemoglobin above 10 g/dL.
- People who are willing and able to follow all the procedures required by the study.
- People who are not incarcerated and are freely able to give their own consent without pressure or legal restrictions (the trial investigator will assess this on a case-by-case basis).
- People who have a confirmed diagnosis of moderate to severe active ulcerative colitis, who initially responded to the medication upadacitinib, and who have since stopped responding to the 30 mg daily dose — with this loss of response occurring within 8 weeks before the screening visit.
- People who have a confirmed diagnosis of moderate to severe active ulcerative colitis with a disease activity score of 5 to 9 on a standard scale, including a bowel lining damage score of 2 to 3, measured at the time of screening.
- People who are female and capable of becoming pregnant must have a negative pregnancy blood test at the screening visit, and must use at least one approved method of contraception from the first day of the study until at least 30 days after the last dose of the study medication.
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 who currently have a diagnosis of Crohn's disease or indeterminate colitis.
- People who currently have fulminant colitis (a severe, rapidly worsening form of colitis) and/or toxic megacolon (a dangerous enlargement of the colon).
- People who have had a clinically significant problem with drug or alcohol misuse in the past 6 months, as judged by the investigator.
- People who have conditions that may affect how the body absorbs medication, such as short bowel syndrome.
- People who have had all or part of their colon removed, have had pouch surgery, or have an ileostomy, or who are planning bowel surgery.
- People who currently have active tuberculosis (TB) or latent (inactive) TB.
- People who received a faecal microbiota transplant (a procedure transferring gut bacteria from a donor) within 30 days before the baseline visit.
- People who are taking strong medications that significantly affect how the body processes the study drug (known as strong CYP3A inhibitors or inducers), including certain herbal therapies or traditional medicines — the treating doctor will need to assess whether these medications could be responsible for the loss of response to upadacitinib.
- People who are currently receiving nutrition delivered directly into a vein (total parenteral nutrition), or who plan to receive this during the study.
- People who test positive for a harmful gut infection called Clostridioides difficile during screening.
- People who have needed intravenous (drip) antibiotics or antifungals within 30 days before the baseline visit, or oral or injected anti-infective treatment within 14 days before the baseline visit.
- People who have a long-term recurring infection or an active viral infection that the investigator considers would make participation unsuitable.
- People who have a current or past history of herpes zoster (shingles) that spread widely through the body, even if it only happened once.
- People who have a current or past history of herpes simplex that spread widely through the body, even if it only happened once.
- People who have a current or previous history of abnormal pre-cancerous changes in the gut lining (gastrointestinal dysplasia), except where such changes were completely removed during or before the screening examination.
- People who have a history of any cancer, except for successfully treated non-melanoma skin cancer or early-stage cervical carcinoma in situ.
- People who have a history of a hole or tear in the gut wall (perforation, unless caused by appendicitis or an injury), diverticulitis (infection of small pouches in the bowel), or who are considered by the investigator to have a significantly increased risk of gut perforation.
- People who have had an allergic reaction or significant sensitivity to upadacitinib or any of its ingredients.
- People who have previously received a stem cell transplant.
- People who have previously received an organ transplant that requires ongoing immune-suppressing medication.
- People who have a history of stroke, heart attack, coronary artery stenting, heart bypass surgery, or a blood clot in the eye (retinal vein occlusion) — although exceptions may be considered by the investigator for events that occurred more than 6 months before the baseline visit, provided a documented assessment supports the benefit outweighing the risk.
- People with known risk factors for blood clots in the veins (VTE), where the investigator has assessed that this trial is the most suitable treatment option and has discussed the risks and benefits with the person.
- People who experienced a serious side effect during previous treatment with upadacitinib that the investigator believes was caused by that medication.
- People who have taken any other investigational (experimental) drug within 30 days or five half-lives of that drug (whichever is longer) before the first dose, or who are currently enrolled in another interventional clinical trial.
- People who used rectal aminosalicylate or corticosteroid treatments, enemas, or suppositories (other than those required for the endoscopy procedure) within 7 days before the screening endoscopy or during the rest of the screening period.
- People who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days before the baseline visit.
- People who received azathioprine or 6-mercaptopurine within 10 days before the baseline visit.
- People who received corticosteroids given directly into a vein within 14 days before screening or during the screening period.
- People who require ongoing corticosteroid treatment in order to remain in the study.
- People who took non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen) within 7 days before the baseline visit — with the exception of topical (skin-applied) NSAIDs and low-dose aspirin taken for heart protection.
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.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
Contact this trial
Principal Investigator: Lucine Vuitton, CHU de Besançon, FRANCE
Phone: +33 (0)9 72 57 61 60
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
Phase 4
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Registry
ClinicalTrials.gov
Start date
15 November 2026
Est. completion
1 November 2029
Primary endpoints
To determine the rate of re-capture of clinical response per adapted Mayo score at week 8 or week 16 (pooled).
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 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.