Risankizumab for Fibrostenotic Crohn's Disease Treatment
Phase 3 · Testing Ustekinumab and Risankizumab · Sites not listed yet · First Affiliated Hospital of Wenzhou Medical University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Ustekinumab (a drug) and Risankizumab (a drug) as a possible treatment. Condition(s) listed: Crohn Disease and Crohn Disease and Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- \- Here's the translation of the provided criteria into English:
- Age between 18 and 80 years old, with no gender restrictions.
- Voluntarily sign an informed consent form.
Plus 8 more requirement(s). There are also 13 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 260 participants are expected to take part.
- Start date: 2025-10-20 (planned).
- Main results expected around 2028-06-20 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Radiological Composite Endpoint (up to 24 weeks)
In the researchers’ words
This study, titled "IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study," is conducted by researchers from the First Affiliated Hospital of Wenzhou Medical University. The primary aim of this research is to evaluate the efficacy and safety of ustekinumab, an IL-23 inhibitor, for patients with fibrostenotic Crohn's disease (CD) who have…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Crohn Disease; Crohn Disease and Ulcerative Colitis |
| Lead sponsor | First Affiliated Hospital of Wenzhou Medical University |
| Collaborators | Taizhou Hospital; Second Affiliated Hospital of Wenzhou Medical University |
| Enrollment | 260 (estimated) |
| Start date | 2025-10-20 |
| Primary completion (est.) | 2028-06-20 |
| First posted | 2025-09-16 |
| Last updated | 2025-09-16 |
| Official title | A Prospective, Open-Label, Randomized Controlled Study of Risankizumab (an IL-23 Inhibitor) for the Treatment of Fibrostenotic Crohn's Disease |
| ClinicalTrials.gov ID | NCT07177118 |
Interventions
- Ustekinumab (Drug)
Ustekinumab group (induction phase with intravenous equivalent doses at weeks 0 and 8, maintenance phase with 90 mg subcutaneously every 8 weeks) - Risankizumab (Drug)
Risankizumab group (induction phase with intravenous 600 mg at weeks 0, 4, and 8, maintenance phase with 360 mg subcutaneously every 8 weeks)
Full eligibility criteria (from the record)
Inclusion Criteria: \- Here's the translation of the provided criteria into English: 1. Age between 18 and 80 years old, with no gender restrictions. 2. Voluntarily sign an informed consent form. 3. Diagnosed with fibrostenosing Crohn's disease by endoscopy and histology, and meet the following criteria: * Presence of symptoms indicating fibrostenosis, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain; * Endoscopic or radiological confirmation of new fibrotic stenosis (not caused by previous dilation/stenting); * The length of stenosis is less than 10 cm, and there are no more than 2 stenoses in a single intestinal segment; 4. Clinical manifestations of intestinal obstruction or sub-obstruction. 5. Insufficient efficacy, intolerance, or contraindications to conventional or biological agents (azathioprine, 6-mercaptopurine, methotrexate, TNF-α inhibitors, etc.). 6. Plan to receive treatment with risankizumab or ustekinumab for the first time. 7. Have not previously used risankizumab or ustekinumab; if other biological agents have been used, they have been discontinued for at least the specified washout period (TNF-α inhibitors ≥8 weeks). Exclusion Criteria: * Here is the translation of the exclusion criteria into English: 1. Age less than 18 or greater than 80 years old. 2. Refusal or inability to sign the informed consent form. 3. Absence of symptoms of fibrostenotic Crohn's disease, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain. 4. Prior stenting and/or dilation treatment for stenosis (within less than 1 year). 5. Pregnancy, lactation, or planning to conceive. 6. Inaccessible endoscopy or presence of clinical conditions incompatible with endoscopy. 7. Presence of abscesses, fistulas, or active complex strictures (not limited to the strictured segment). 8. Stenosis length of 10 cm or greater, or more than 2 strictures in a single intestinal segment. 9. Severe coagulation dysfunction (platelet count < 50,000; INR > 1.5). 10. Presence of end-stage organ failure, positive for Human Immunodeficiency Virus, uncontrolled infections, or a history of malignant tumors within the past 5 years. 11. Having received or started treatment with risankizumab or ustekinumab. 12. Investigator determines other conditions that make participation in this clinical study unsuitable.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.