Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT06520397
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab and Upadacitinib — DRUG
    Participants will continue ustekinumab 90 mg administered subcutaneously every 8 weeks. In addition, upadacitinib will be administered orally once daily. During the induction period (Weeks 0-12), upadacitinib will be initiated at 15 mg or 30 mg daily, with escalation up to 45 mg daily permitted based on disease activity, clinical response, and tolerability. From Week 12 to Week 16, dose adjustment (15 0r 30 daily) will be allowed according to clinical judgment. Clinical efficacy will be assessed at Week 16.
  • Ustekinumab — DRUG
    Participants will receive an additional induction dose of Ustekinumab administered intravenously at 6 mg/kg at baseline. This will be followed by subcutaneous maintenance therapy of 90 mg every 4 weeks. Clinical efficacy will be evaluated at week 16.

Study Details

The goal of this clinical trial is to evaluate the efficacy and safety of dual-target therapy (Ustekinumab combined with Upadacitinib) versus intensified Ustekinumab monotherapy in patients with Crohn's disease who have an inadequate response to standard doses of Ustekinumab. The main questions it aims to answer are: Is dual-target therapy more effective than intensified Ustekinumab monotherapy in achieving endoscopic remission in Crohn's disease patients? Is dual-target therapy as safe as intensified Ustekinumab monotherapy in terms of adverse events? Participants will: Receive either dual-target therapy (Ustekinumab combined with Upadacitinib) or intensified Ustekinumab monotherapy. Attend regular clinic visits for monitoring and assessments. Complete questionnaires about their symptoms and quality of life. Undergo routine blood tests and endoscopic evaluations to assess disease activity. Researchers will compare the dual-target therapy group to the intensified Ustekinumab monotherapy group to see if dual-target therapy is more effective in achieving endoscopic remission and is as safe in terms of adverse events.

Key Dates

Start date
Jul 15, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dual-target Therapy Group
    Participants in this group will receive the standard maintenance dosage of Ustekinumab administered subcutaneously, combined with the addition of Upadacitinib administered orally.
  • Active Comparator: Intensified Ustekinumab Monotherapy Group
    Participants in this group will receive an additional induction dose of Ustekinumab administered intravenously, followed by maintenance therapy with Ustekinumab.

Primary Outcome Measure

The primary endpoint of the study is the endoscopic remission rate at week 16. [ Time Frame: Week 16 ]

Central Contacts

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