RecruitingPhase 4NCT06520397

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

Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease Patients With an Insufficient Response to Standard-dose Ustekinumab: A Randomized Controlled Trial


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

214 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining two drugs — upadacitinib (a JAK inhibitor) and ustekinumab (a biologic) — works better than higher doses of ustekinumab alone in people with Crohn's disease that is not responding to standard treatment. **You may be eligible if...** - You are between 18 and 70 years old - You have active Crohn's disease confirmed by colonoscopy - You have already tried and not fully responded to an anti-TNF biologic and at least 16–24 weeks of ustekinumab treatment - You have active inflammation confirmed by blood tests, stool tests, or imaging - You are able to follow the study protocol **You may NOT be eligible if...** - You are allergic to upadacitinib or ustekinumab - You have untreated colon cancer or high-grade abnormal cells in the colon - You have a current active infection (such as pneumonia or shingles) - You are likely to need surgery for Crohn's disease during the study - You have a history of blood clots (deep vein thrombosis) - You have had lymphoma or other lymphoproliferative disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUstekinumab and Upadacitinib

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.

DRUGUstekinumab

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.


Locations(1)

Wei Wang

Guangzhou, Guangdong, China

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NCT06520397


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