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Compares treatment options for Crohn Disease
Official title Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease
ClinicalTrials.gov ID: NCT06520397
What this study is testing
What is Ustekinumab and Upadacitinib?
Ustekinumab and Upadacitinib is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for crohn disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Prior Ustekinumab Treatment: Participants must have had primary non-response or secondary loss of response to TNFi, and have undergone at least 16-24...
- Consent and Compliance: Participants must be capable and willing to provide written informed consent and comply with the requirements of the study...
- General Health: The principal investigator (or designee) must determine that the participant is in good general health based on medical history...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.