UCNot yet recruiting
Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab
Phase 3 · Testing Infliximab · Sites not listed yet · JAROSLAW KIERKUS
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 6 to 17
- Any sex
Some of the main requirements, copied from the record:
- Participant aged 6 to 17 years at the time of study entry.
- Patient with moderate or severe UC defined by the PUCAI score (min. 30 points) - diagnosed at least 1 month before the qualifying visit.
- Individuals who failed to respond to, lost response to, or were intolerant to treatment with at least 1 of the following agents:
Plus 5 more requirement(s). There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2024-10-01 (planned).
- Main results expected around 2028-04-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Safety of biological treatment with vedolizumab and infliximab assessed/defined by the number of drug-related adverse events (AEs). (screening - Week 20)
In the researchers’ words
This is a multicenter, double-blind, randomized study to compare the safety, effectiveness and immunogenicity (antibodies against drug) of two biological drugs administered intravenously - vedolizumab (a drug not registered in pediatric patients) and infliximab (used as standard therapy), in pediatric patients with UC aged 6-18 years. Before enrollment to the study, informed consent must be obtained from the…
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 | Not yet recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | JAROSLAW KIERKUS |
| Enrollment | 60 (estimated) |
| Start date | 2024-10-01 |
| Primary completion (est.) | 2028-04-30 |
| First posted | 2024-09-26 |
| Last updated | 2024-09-26 |
| Official title | Assessment of Safety and Efficacy of Vedolizumab in Pediatric Uclerative Colitis in Comparison With Standard Biological Therapy With Infliximab |
| ClinicalTrials.gov ID | NCT06614387 |
Interventions
- Infliximab (Drug)
Patients meeting the inclusion criteria and not having any of the exclusion criteria will be randomized 1:1 to one of two study arms - intravenous administration of blinded active drug, infliximab or vedolizumab at weeks 0, 2, 6 and 14. Infliximab will be administered at a dose 5mg/kg body weight, and vedolizumab at a dose of 300 mg (body mass > 40 kg) and 10 mg/kg (body mass < 40kg).
Full eligibility criteria (from the record)
Inclusion criteria
1. Participant aged 6 to 17 years at the time of study entry.
2. Patient with moderate or severe UC defined by the PUCAI score (min. 30 points) - diagnosed at least 1 month before the qualifying visit.
3. Individuals who failed to respond to, lost response to, or were intolerant to treatment with at least 1 of the following agents:
* corticosteroids (prednisone at a dose of 1 mg/kg/day with a maximum dose of 40 mg/day, budesonide MMX 9 mg/day) or immunomodulating drugs (e.g. AZA, 6-MP, MTX).
* in the case of 5 - ASA adrugs, corticosteroids, immunomodulating drugs, doses should remain stable for 2 weeks before administration of the study drug
4. Patients with UC proximal to the rectum (i.e. not limited to proctitis).
5. At least Mayo 1 on the endoscopic scale
6. People with up-to-date vaccinations in accordance with the preventive vaccination program adopted in Poland.
Exclusion criteria
1. People who have been previously treated with biological antiintegrin preparations, including: natalizumab, efalizumab, etrolizumab or addressin-1 adhesion molecule antagonists or rituximab.
2. People who were previously treated with vedolizumab.
3. People who were previously treated with infliximab
4. People with hypersensitivity or allergy to any of the excipients of vedolizumab or infliximab
5. People with active brain/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other serious neurological disorder including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
6. Individuals who currently require or are expected to require surgical intervention for UC during this study.
7. People who have had a partial or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal stoma, or known permanent intestinal stricture.
8. People with a current diagnosis of unspecified colitis.
9. People with clinical features suggestive of monogenic inflammatory bowel disease of very early onset.
10. The participant has other serious comorbidities that will limit his or her ability to complete the study.
11. Abnormal laboratory tests:
* Hgb ≤ 8 g/dl
* Leukocytes ≤ 2.5 x 10*9 cells/L
* ALT and/or AST ≥ 3 x upper limit of normal
* positive Quantiferon result
* positive result in the stool sample for Clostridium difficile and/or stool culture for alarm pathogens Security
At every check-up visit:
* occurrence of: adverse events (AEs), serious AEs (serious AEs-SAEs), infections including opportunistic infections such as PML, liver damage, malignant tumors, infusion-related reactions and hypersensitivity
* vital signs, results of standard laboratory testsLocations (0)
No sites listed yet. The official record has contact information.
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.