Crohn'sRecruiting
Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease
Phase 4 · Testing Ustekinumab and Upadacitinib and Ustekinumab · 1 site · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Ustekinumab and Upadacitinib (a drug) and Ustekinumab (a drug) to see if it can prevent disease or complications. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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.
Plus 2 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 214 participants are expected to take part.
- Start date: 2024-07-15.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- The primary endpoint of the study is the endoscopic remission rate at week 16. (Week 16)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 214 (estimated) |
| Start date | 2024-07-15 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2024-07-25 |
| Last updated | 2026-02-23 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06520397 |
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… - 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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Wei Wang | Guangzhou, Guangdong | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.