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Tests treatment safety and results for Crohn's Diseases
Official title Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
ClinicalTrials.gov ID: NCT06902987
What this study is testing
What is Upadacitinib?
Upadacitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn's diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Anal fistula is the most common perianal lesion of Crohn's disease (CD), and the incidence of anal fistula in eastern CD population is significantly higher than that in Western population. The treatment of CD active anal fistula is difficult, which seriously affects the quality of life of patients and consumes a lot of medical resources.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age ≥18 years and ≤70 years;
- Make a clear diagnosis of CD according to the "Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)";
- The disease severity of CD was moderate and severe according to Crohn's diseaseactivityindex (CDAI), that is, CDAI score \> 220.
- Complicated with active anal fistula, that is, on the basis of perianal MRI confirmation of anal fistula, the patient has perianal pain, fluid...
- Patients with previous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, atrial thrombosis, peripheral artery thrombosis and...
You likely can't join if
- History of allergy to the active ingredient of upatinib;
- Severe damage of liver and kidney function; Hemoglobin \< 8g/L;
- History of malignant tumor;
- Patients with previous thrombosis;
- Neutrophil count \< 1×109/L; , or lymphocyte count \< 500×109/L;
- Patients with intestinal complications (including intestinal stricture with proximal intestinal dilation or intestinal fistula). Diagnosis based on...
See the full eligibility criteria
- Age ≥18 years and ≤70 years;
- Make a clear diagnosis of CD according to the "Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)";
- The disease severity of CD was moderate and severe according to Crohn's diseaseactivityindex (CDAI), that is, CDAI score \> 220.
- Complicated with active anal fistula, that is, on the basis of perianal MRI confirmation of anal fistula, the patient has perianal pain, fluid seepage and other symptoms, and the transanal surgeon judges that the...
- Patients with previous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, atrial thrombosis, peripheral artery thrombosis and cerebral thrombosis confirmed by imaging;
- Informed consent. The people gave barrier-free informed consent, voluntarily participated in the clinical study and signed the informed consent.
- History of allergy to the active ingredient of upatinib;
- Severe damage of liver and kidney function; Hemoglobin \< 8g/L;
- History of malignant tumor;
- Patients with previous thrombosis;
- Neutrophil count \< 1×109/L; , or lymphocyte count \< 500×109/L;
- Patients with intestinal complications (including intestinal stricture with proximal intestinal dilation or intestinal fistula). Diagnosis based on CTE/MRE.
- Presence of enterostomy;
- With active severe infection (such as sepsis) or opportunistic infection (such as active tuberculosis, shingles);
- Pregnant or planning pregnancy.
- Patients with vaginal fistula;
- Patients with anorectal stenosis.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.