Comparing dual-target therapy with intensified Ustekinumab for 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
This study is testing if a new combination treatment of Ustekinumab and Upadacitinib can help people with Crohn's disease feel better compared to a higher dose of Ustekinumab alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | Ustekinumab, Upadacitinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06520397 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a dual-target therapy combining Ustekinumab and Upadacitinib against intensified Ustekinumab monotherapy in patients with Crohn's disease who have not responded adequately to standard Ustekinumab doses. Participants will receive either treatment and will undergo regular monitoring, including questionnaires about their symptoms, quality of life assessments, blood tests, and endoscopic evaluations to measure disease activity. The study aims to determine if the dual-target therapy is more effective and equally safe compared to intensified Ustekinumab therapy in achieving endoscopic remission.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with active Crohn's disease who have previously shown inadequate response to Ustekinumab.
Not a fit: Patients who have not previously been treated with Ustekinumab or those with strictures contributing to their Crohn's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with Crohn's disease who do not respond to standard Ustekinumab therapy.
How similar studies have performed: Other studies have shown promise with dual-target therapies in inflammatory bowel diseases, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female participants aged 18 to 70 years at baseline (week 0). * 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: * Allergies: Participants with known allergies to UPA or UST excipients or components. * 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.
Where this trial is running
Guangzhou, Guangdong
- Wei Wang — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Wei Wang
- Email: wangw239@mail.sysu.edu.cn
- Phone: 86-020-38254101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.