Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease

NCT06902987 | Recruiting Phase 1

• 1 other identifier: 2024ZSLYEC-371
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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. Injection of biological agents is the most commonly used method for the treatment of CD anal fistula, small molecule drugs can be taken orally, and the curative effect is more lasting. Upadacitinib was the first small molecule drug approved for CD treatment in China on June 30, 2023. At present, there is only one post-subgroup analysis of a global Phase 3 clinical study on Upatinib in the treatment of CD anal fistula, and the number of active anal fistula cases included is small, and the study objects are mostly western populations. This study intends to include CD patients with active anal fistula, and adopts the method of single-center single-arm study to explore the efficacy of Upatinib in the treatment of CD anal fistula, so as to provide more evidence-based medical evidence for the drug selection of CD anal fistula in China.

Conditions

Crohn's Diseases; Active Anal Fistula; Upadacitinib

Outcome Measures

Primary Outcomes (2)

• Clinical response at 12 weeks of treatment

  Clinical response was defined as 100% closure of the external orifice of the fistula and no fluid seepage from the patient's complaint or physician's acupressure

  12 weeks

• Imaging remission at 12 weeks of treatment

  Imaging remission was defined as the absence of \> 2 cm pyo-filling fistula on perianal MRI and the absence of edema and active inflammation

  12 weeks

Secondary Outcomes (9)

• The clinical response rate of anal fistula at week 12/48 of treatment.

  12 weeks、48 weeks

• The clinical remission rate of anal fistula at week 12/48 of treatment.

  12 weeks、48 weeks

• The imaging remission rate of anal fistula at week 12/48 of treatment

  12 weeks、48 weeks

• The Perianal Disease Activity Index score at week 12/48 of treatment

  12 weeks、48 weeks

• The van Assche Magnetic Resonance Imaging (MRI) Score of anal fistula at week 12/48 of treatment.

  12 weeks、48 weeks

Study Arms (1)

The primary endpoint was the combined response rate at 12 weeks of treatment

OTHER

Combined response refers to clinical response plus imaging response. Clinical response was defined as 100% closure of the external orifice of the fistula and no fluid seepage from the patient's complaint or physician's acupressure. Imaging remission was defined as the absence of \> 2cm pyo-filling fistula on perianal MRI and the absence of edema and active inflammation. Clinical response for the primary endpoint was judged by two experienced senior physicians and, if inconsistent, by a third clinician. The imaging was judged by two senior doctors in the independent third party diagnostic team, and if the judgment was inconsistent, the third team physician made the judgment

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

Enrolled patients received oral upatinib treatment with a conventional induction dose of 45mg/d for 12 weeks, followed by a maintenance dose of 15m/d or 30mg/d

The primary endpoint was the combined response rate at 12 weeks of treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 seepage and other symptoms, and the transanal surgeon judges that the symptoms are related to anal fistula activity;
• Patients with previous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, atrial thrombosis, peripheral artery thrombosis and cerebral thrombosis confirmed by imaging;
• Informed consent. The subjects gave barrier-free informed consent, voluntarily participated in the clinical study and signed the informed consent.

You may not qualify 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 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth afflicated of Sun-yat sen university

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

upadacitinib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: March 30, 2025
• Study Start: January 17, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CN (1)