Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07444060
Status
Recruiting
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Conditions

  • CD - Crohn's Disease
  • IBD - Inflammatory Bowel Disease
  • Stricture; Bowel

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab (GUS) — DRUG
    ① Induction phase (Weeks 1-12): GUS 200 mg intravenously (IV) every 4 weeks for 3 doses, followed by a maintenance phase with GUS 100 mg subcutaneously (SC) every 8 weeks (for patients with all indicators within the normal range). ② Maintenance phase: Dosing adjustments shall be optimized based on the clinician's experience: If any disease activity occurs during the maintenance phase (e.g., suboptimal levels of CRP or FCP), administer GUS 200 mg SC every 4 weeks, or GUS 100 mg SC every 8 weeks plus enteral nutrition accounting for no more than 50% of the total daily energy intake. In case of persistent disease activity, administer intensive intravenous infusion of GUS 200 mg for 3 doses based on patient needs and shared decision-making.
  • Ustekinumab (UST) — DRUG
    ① Induction phase (Weeks 1-8): UST 6 mg/kg intravenously (IV) for 1 dose, followed by UST 90 mg subcutaneously (SC) every 8 weeks. A maintenance dose of 90 mg SC shall be administered every 8 or 12 weeks thereafter on a case-by-case basis. ② Experience-based dosing optimization and adjustment: If C-reactive protein (CRP) or fecal calprotectin (FCP) levels are suboptimal, two treatment approaches shall be adopted based on patient needs and shared decision-making: intravenous intensification therapy (predominantly 2 to 3 IV doses, i.e., 260 mg or 390 mg, with a follow-up visit at 8 weeks); or 90 mg SC with a shortened administration interval (with a follow-up visit at 4 to 6 weeks). ③ The duration of Exclusive Enteral Nutrition (EEN) use shall not exceed 2 weeks. If enteral nutrition support is required beyond 2 weeks, switch to Partial Enteral Nutrition (PEN), which shall account for less than 50% of the patient's total energy requirement.

Study Details

This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with Guselkumab or Ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.

Key Dates

Start date
Mar 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: GUS
    Guselkumab standard usage and optimized usage for the treatment of patients with symptomatic stricturing Crohn's disease
  • Arm: UST
    Ustekinumab standard usage and optimized usage for the treatment of patients with symptomatic stricturing Crohn's disease

Primary Outcome Measure

Continuation of ustekinumab [ Time Frame: up to 52 weeks ]

Central Contacts

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