Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease
NCT ID: NCT06520397
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
214 participants
INTERVENTIONAL
2024-07-15
2027-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Ustekinumab and Upadacitinib
Participants in this group will maintain the original Ustekinumab regimen, receiving 90 mg administered subcutaneously every 8 weeks. In addition, they will receive Upadacitinib administered orally at a dosage of 45 mg daily for 12 weeks. After the 12-week period, the dosage of Upadacitinib will be adjusted based on patient condition and clinical judgment, continuing until the evaluation at week 16. Clinical efficacy of the dual-target therapy will be evaluated at week 16.
Intensified Ustekinumab Monotherapy Group
Participants in this group will receive an additional induction dose of Ustekinumab administered intravenously, followed by maintenance therapy with Ustekinumab.
Ustekinumab
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.
Interventions
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Ustekinumab and Upadacitinib
Participants in this group will maintain the original Ustekinumab regimen, receiving 90 mg administered subcutaneously every 8 weeks. In addition, they will receive Upadacitinib administered orally at a dosage of 45 mg daily for 12 weeks. After the 12-week period, the dosage of Upadacitinib will be adjusted based on patient condition and clinical judgment, continuing until the evaluation at week 16. Clinical efficacy of the dual-target therapy will be evaluated at week 16.
Ustekinumab
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.
Eligibility Criteria
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Inclusion Criteria
* Active Crohn's Disease: Participants must have active Crohn's disease at baseline, defined as: CDAI \> 150 and Endoscopic activity with SES-CD \> 6, or SES-CD \> 4 (for isolated ileal disease), excluding the contribution of the stricture component (Excluding the stricture component ensures recruitment of patients with a better chance of improvement, given the primary endpoint is endoscopic remission), and at least one of the following: CRP \> 10 mg/L (upper limit of normal on local assay), Fecal calprotectin (FC) \> 250 μg/g, active disease confirmed by imaging.
* Prior Ustekinumab Treatment: Participants must have had primary non-response or secondary loss of response to TNFi, and have undergone at least 16-24 weeks of standard-dose ustekinumab treatment, but still have active CD.
* Consent and Compliance: Participants must be capable and willing to provide written informed consent and comply with the requirements of the study protocol.
* General Health: The principal investigator (or designee) must determine that the participant is in good general health based on medical history, laboratory test results, physical examination, chest X-ray (CXR), and 12-lead electrocardiogram (ECG) obtained during the screening period.
Exclusion Criteria
* Colonic Neoplasia: Participants with untreated or unresolved high-grade dysplasia or colon cancer.
* Active Infections: Participants with active infections at screening or baseline, including but not limited to pneumonia, pyelonephritis, or herpes zoster, or those with evidence of chronic infections that make them unsuitable for the study as per the investigator's assessment.
* Surgical Intervention: Participants who currently require or are expected to require surgical intervention for CD during the study period.
* Thrombosis: Participants with thrombosis identified through limb venous Doppler ultrasound or D-dimer screening.
* Lymphoproliferative Disorders: Participants with a history of lymphoproliferative disorders, including lymphoma, or those with signs and symptoms indicative of possible lymphoproliferative disease such as lymphadenopathy and/or splenomegaly.
* Immunodeficiency: Participants with any known congenital or acquired immunodeficiency, including common variable immunodeficiency, HIV infection, or organ transplantation.
* Pregnancy: Female participants with a positive pregnancy test at screening or baseline (week 0).
* Lactation or Pregnancy Plans: Female participants who are breastfeeding or planning to become pregnant during the study.
* Substance Abuse: Participants with a history of drug abuse (defined as the use of any illicit drug) or alcohol abuse within 1 year prior to screening.
* Investigator's Discretion: Participants deemed unsuitable for the study by the investigator for any reason.
18 Years
70 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Wei Wang
Principal Investigator
Locations
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Wei Wang
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2024ZSLYEC-070
Identifier Type: -
Identifier Source: org_study_id