Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

NCT06614387 | Not Yet Recruiting Phase 3

• 1 other identifier: CT 2023-509775-16
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 participant's legal guardian and, additionally, from the participant aged \>16 years before any procedures are performed.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Vedolizumab; Infliximab; Children

Outcome Measures

Primary Outcomes (1)

• Safety of biological treatment with vedolizumab and infliximab assessed/defined by the number of drug-related adverse events (AEs).

  Information on AEs will be collected on each check-up visit, physical examination, vital signs and lab test will be performed

  screening - Week 20

Study Arms (2)

Infliximab arm

ACTIVE COMPARATOR

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).

Drug: Infliximab

Vedolizumab arm

EXPERIMENTAL

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).

Drug: Infliximab

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).

Also known as: vedolizumab

Infliximab arm; Vedolizumab arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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
• Patients with UC proximal to the rectum (i.e. not limited to proctitis).
• At least Mayo 1 on the endoscopic scale
• People with up-to-date vaccinations in accordance with the preventive vaccination program adopted in Poland.

You may not qualify if:

• People who have been previously treated with biological antiintegrin preparations, including: natalizumab, efalizumab, etrolizumab or addressin-1 adhesion molecule antagonists or rituximab.
• People who were previously treated with vedolizumab.
• People who were previously treated with infliximab
• People with hypersensitivity or allergy to any of the excipients of vedolizumab or infliximab
• 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.
• Individuals who currently require or are expected to require surgical intervention for UC during this study.
• People who have had a partial or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal stoma, or known permanent intestinal stricture.
• People with a current diagnosis of unspecified colitis.
• People with clinical features suggestive of monogenic inflammatory bowel disease of very early onset.
• The participant has other serious comorbidities that will limit his or her ability to complete the study.
• 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

Sponsors & Collaborators

• JAROSLAW KIERKUS: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Infliximab; vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Allocation to therapeutic subgroups will be in a 1:1 ratio.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Children's Memorial Health Institute

Model Details: 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 participant's legal guardian and, additionally, from the participant aged \> 16 years before any procedures are performed.

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: September 26, 2024

Record last verified: 2024-09