Printed from Voxsanity (voxsanity.com.au) — NCT07663526 — 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
NCT07663526
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 and able to sign the consent form agreeing to take part in the study.
- People aged 18 to 70 years (inclusive), of any gender.
- People who have been formally diagnosed with Crohn's disease according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease, and whose disease is moderately to severely active, and who have not responded well to, cannot tolerate, or cannot use steroid or immunosuppressant treatments.
- People with Crohn's disease whose treating doctor has assessed the risks and benefits and decided to prescribe Tabellvi® Adalimumab Injection for them.
- Women who could become pregnant must agree to use a contraceptive method approved by the study doctor during the trial.
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 for whom the treating doctor considers Tabellvi® Adalimumab Injection to be unsuitable, based on the medication's prescribing information and clinical judgment.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- People who have a known allergy or sensitivity to any ingredient in Tabellvi® Adalimumab Injection.
- People who have an active, long-term, or recurring infection, or who have a history of serious internal infections such as listeriosis or histoplasmosis.
- People who received intravenous (drip) antibiotic or antifungal treatment within 30 days before the first dose, or who took oral anti-infective medication within 14 days before the first dose.
- People with active tuberculosis; or latent (inactive) tuberculosis that has not been properly treated; or people who are HIV-positive; or people whose blood tests show a current or past hepatitis C infection; or people whose blood tests indicate active or insufficiently controlled hepatitis B infection.
- People with a syphilis infection that requires treatment.
- People with moderate to severe heart failure, a recent stroke, or other health conditions that could put them at risk by participating in this study.
- People who currently have, or have a history of, cancer (including blood cancers such as lymphoma or leukaemia), with the exception of certain fully treated skin or cervical cancers that have not spread (confirm with trial site).
- People who have a history of diseases affecting the protective coating of nerves (demyelinating diseases, such as multiple sclerosis or myelitis), or who have nerve-related symptoms that may suggest such a condition.
- People who have had bowel surgery within the past 6 months, or who are planning to have bowel surgery at any point during the study.
- People who are currently receiving, or plan to receive, total nutrition delivered entirely through a drip (intravenous feeding) at any point during the study.
- People who have a stoma (an opening in the abdomen for waste) or a specific type of surgically created internal pouch (ileal pouch-anal anastomosis).
- People who have abnormal passageways (fistulas) inside or outside the body, except for fistulas around the anal area that do not involve an abscess.
- People who have a known blockage or narrowing in the bowel that is causing symptoms.
- People who have been diagnosed with ulcerative colitis or a form of inflammatory bowel disease that cannot be clearly classified.
- People whose blood tests or other tests during the screening period show certain abnormal results, including: liver enzyme levels (AST or ALT) more than 1.5 times the upper normal limit; low white blood cell count (below 3.0×10⁹/L); a clinically significant abnormal heart tracing (ECG); high bilirubin levels at or above 3 mg/dL (unless due to a harmless inherited condition called Gilbert's syndrome); or elevated creatinine levels above 1.6 mg/dL indicating reduced kidney function.
- People whose other blood or test results during screening are considered significantly abnormal by the study doctor, even if not listed above.
- People who have received another type of medication known as a TNF-α inhibitor within 12 weeks before the first dose of Tabellvi® Adalimumab Injection.
- People who are currently taking part in another clinical trial.
- People who the study doctor considers to be unsuitable for any other reason.
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
Phone: 13651829887
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 December 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Serious Adverse Event (SAE); Adverse Event (AE); Adverse Drug Reaction (ADR); Serious Adverse Drug Reaction; Clinical remission (CDAI < 150)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 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.