Printed from Voxsanity (voxsanity.com.au) — NCT07677514 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Crohns Disease And Colitis
Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting
NCT07677514
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 75 years, of any gender.
- People who have been diagnosed with Crohn's disease (CD) for at least 12 weeks before the screening visit, confirmed by camera examination of the bowel (endoscopy) and tissue samples (biopsy).
- People with moderately to severely active Crohn's disease, shown by a specific disease activity score (CDAI between 220 and 450) and confirmed active inflammation in the small intestine and/or large bowel on a camera examination done during screening, meeting specific scoring thresholds set by the trial.
- People who have not responded well to, lost response to, or could not tolerate one or more standard Crohn's disease treatments — such as steroids, certain immune-suppressing medicines, or advanced therapies including anti-TNF, anti-integrin, anti-IL-23, anti-IL-12/23, or JAK inhibitor medicines (note: not responding to 5-ASA alone does not meet this requirement).
- People already taking certain Crohn's disease medicines at the time of screening may be eligible, provided those medicines have been at a stable dose for the required period before the screening endoscopy and remain stable during the study — this applies to oral 5-ASA (stable for at least 2 weeks), oral steroids at low doses (stable for at least 2 weeks), and oral immune-suppressing medicines such as azathioprine, 6-mercaptopurine, or methotrexate (stable for at least 4 weeks); people taking methotrexate are advised to also take folic acid unless there is a medical reason not to (confirm with trial site).
- Female participants must meet one of the following conditions: have gone through menopause (no periods for at least 12 consecutive months with no other medical explanation); have had a permanent procedure that means they cannot become pregnant (such as removal of the uterus, both fallopian tubes, or both ovaries); or be of childbearing potential and agree, along with their non-sterilised male partner, to use highly effective contraception from the time of signing the consent form until at least 30 days after the last dose of the study treatment (women on hormone replacement therapy whose menopausal status is uncertain must use a highly effective non-oestrogen-containing hormonal contraceptive if they wish to continue HRT during the study — confirm with trial site).
- Female participants must not be pregnant or breastfeeding from the screening period until at least 30 days after the last dose (or longer if local regulations require), and must have no plans to become pregnant or donate eggs during this time.
- Male participants who have not had a vasectomy and whose sexual partner could become pregnant must agree to use acceptable contraception from the first dose until at least 90 days after the last dose, and must have no plans to father a child or donate sperm during the study or for 90 days after the last dose.
- People who are willing and able to attend all planned visits, follow the study plan, complete daily diaries, undergo endoscopy, provide laboratory samples, and follow all other study procedures, and who have signed the consent form voluntarily.
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 with a known allergy to any ingredient in the study drug or placebo.
- People who have previously received a treatment that increases a substance called microRNA-124 (miR-124), such as a drug called ABX464.
- People who have previously not responded to more than three advanced therapies for Crohn's disease, or who have not responded to two advanced therapies that work in different ways.
- People who have taken certain immune-suppressing medicines (cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or thalidomide) within 4 weeks before the screening endoscopy.
- People who have received biologic medicines (such as anti-TNF, anti-integrin, anti-IL-23, or anti-IL-12/23 treatments) within 8 weeks before the screening endoscopy, or within 5 half-lives of the drug — whichever is longer.
- People who have ever previously received natalizumab or any other medicine in the same class (α4β1 integrin antagonists).
- People who have taken small-molecule targeted medicines (such as upadacitinib) within 4 weeks before the screening endoscopy, or within 5 half-lives of the drug — whichever is longer.
- People who have received high-dose intravenous (IV) steroids (such as methylprednisolone 60 mg/day or hydrocortisone 300 mg/day) within 2 weeks before the screening endoscopy.
- People who stopped taking oral immune-suppressing medicines (azathioprine, 6-mercaptopurine, or methotrexate) within 4 weeks before the screening endoscopy, or who stopped oral 5-ASA or oral steroids within 2 weeks before the screening endoscopy.
- People who have used rectal aminosalicylate or steroid preparations, enemas, or suppositories (other than those needed for the endoscopy procedure) within 2 weeks before the screening endoscopy.
- People who have had total tube feeding (enteral nutrition), intravenous feeding (parenteral nutrition), or a faecal microbiota transplant within 4 weeks before the screening endoscopy.
- People with known narrowing of the bowel causing symptoms, or where the endoscope cannot pass due to such narrowing.
- People with evidence or clinical suspicion of another form of inflammatory bowel disease (such as ulcerative colitis or indeterminate colitis), or another active inflammatory bowel condition such as infectious colitis, ischemic colitis, radiation colitis, microscopic colitis, or uncontrolled coeliac disease.
- People with an untreated active external fistula, perianal fistula, or abscess at screening (people with stable fistulas that have no abscess and minimal or no drainage may be considered; people who have had a skin or perianal abscess that was fully drained and treated at least 3 weeks before the screening colonoscopy — or at least 8 weeks for abscesses inside the abdomen — and who do not need further surgery may also be considered — confirm with trial site).
- People with a current stoma (ostomy) or an internal bowel pouch (ileal pouch).
- People who are missing more than two of the following five bowel sections: the end of the small intestine (terminal ileum), the right colon, the transverse colon, the left colon, and the sigmoid colon and rectum.
- People who have had more than 100 cm of small bowel removed, or who have short bowel syndrome.
- People who have had bowel resection surgery within 3 months before the start of the study (baseline).
- People who may need bowel surgery during the study period.
- People with evidence of abnormal or precancerous changes in the colon (dysplasia, excluding completely removed low-grade lesions), or bowel polyps or growths (excluding completely removed adenomatous polyps).
- People with a history of blood or lymph node cancers (such as lymphoma), or symptoms suggesting such conditions, including swollen lymph nodes or an enlarged spleen.
- People who have had any cancer in the past 5 years (people who had certain skin cancers or early-stage cervical changes that were fully treated and cleared at least 12 months before signing the consent form may be considered — confirm with trial site).
- People with unstable or poorly controlled serious health conditions affecting the heart, brain and blood vessels, lungs, digestive system (other than CD), liver, kidneys, hormones, blood, or nervous system, which could affect safety or the study results.
- People who have had a heart attack or unstable chest pain (angina) in the past 6 months, certain serious heart rhythm problems, or heart failure classified as NYHA Class III or IV; people with a personal or family history of a heart condition called long QT syndrome, or with a significantly prolonged electrical interval in the heart (QTc interval) measured at the start of the study (above specific thresholds for males and females — confirm with trial site).
- People with certain abnormal results on blood virus tests, including: a positive test for hepatitis B surface antigen (HBsAg); a positive hepatitis B core antibody test with detectable hepatitis B virus in the blood; a positive hepatitis C antibody test (people who were successfully treated for hepatitis C at least 1 year ago with no recurrence and undetectable virus may be considered — confirm with trial site); a positive HIV antibody test; or a positive syphilis antibody test.
- People with active tuberculosis (TB), or latent TB that is not being treated with preventive medicine (people receiving preventive treatment for latent TB may be considered — confirm with trial site); or people with a history of TB that was not fully cured.
- People who test positive for a bowel infection called Clostridioides difficile at screening (if treated and retested at least 2 weeks after completing treatment, participation may be considered — confirm with trial site).
- People who have had a serious or recurring Grade 3 or 4 infection in the 2 months before screening, a history of opportunistic infections during periods without immune-suppressing treatment, a flare-up of shingles (herpes zoster) in the 2 months before screening, an active infection at the time of screening, or a severe infection requiring hospitalisation or intravenous antibiotics in the month before or during screening (a fungal nail infection is acceptable).
- People with any other infection history that the trial doctor believes could worsen if they take part in the study.
- People with certain abnormal blood test results at screening, including: very low white blood cell count (neutrophils below 0.75×10⁹/L); low haemoglobin (80 g/L or below); low platelet count (below 100×10⁹/L); significantly elevated liver enzymes (ALT or AST at 2 or more times the upper limit of normal); elevated bilirubin levels above a certain threshold (with some exceptions for a condition called Gilbert's syndrome — confirm with trial site); or reduced kidney function below a specific threshold measured by a standard calculation (eGFR below 60 mL/min/1.73 m²).
- People who have had an organ transplant and are still taking immune-suppressing medicines because of it.
- People who have received a live vaccine within 3 months before being assigned to a treatment group, or who plan to receive a live vaccine during the study.
- People who cannot have a colonoscopy (camera examination of the bowel) for any reason.
- People with a history of drug abuse or alcohol abuse or dependence.
- People who are pregnant, suspected to be pregnant, or currently breastfeeding.
- People who have taken part in another clinical trial involving an experimental drug or device within 3 months before being assigned to a treatment group.
- People who, in the trial doctor's opinion, are unsuitable for the study for any other reason.
- People who are currently taking certain medicines that interact with a liver enzyme called CYP1A2 and have a narrow margin of safe dosing (examples include clozapine, theophylline, ropinirole, warfarin, and methadone) within 5 half-lives before starting the study treatment.
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.
Contact this trial
Phone: +8617714378726
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Jiangsu Carephar Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
12 July 2026
Est. completion
12 October 2026
Where this trial is recruiting
🇨🇳 China
🇺🇸 United States
Primary endpoints
Proportion of study participants achieving clinical response based on CDAI score at Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 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.