A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

NCT06443502 | Recruiting Phase 3

• 2 other identifiers: Vedolizumab-30412023-504773-20-00
• Study Type: interventional
• Target: 30
• Locations: 8 countries
• Sites: 14

Brief Summary

When some people have their large bowel removed, a surgeon can make a "pouch" from part of the small bowel to connect it to the back passage (anus). Pouchitis is when the pouch becomes inflamed (swollen) or infected. The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation. Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems (adverse events or side effects) and to look for any changes in the well-being of participants during their treatment with vedolizumab. This study consists of two parts: Part 1 includes the induction and maintenance periods, and Part 2 includes the continued maintenance period. Participants will receive up to 12 infusions of vedolizumab. In Part 1 of the study, first 3 infusions are in first 6 weeks (Day 1, Week 2 and Week 6). Participants who are getting benefit may continue with the treatment for up to 7.5 months (30 weeks) in the maintenance period for Part 1. After completing treatment with vedolizumab in Part 1, participants will visit their clinic for a health check at Week 34. Participants who show clinical response at Week 34 will continue to Part 2, receiving vedolizumab every 8 weeks for an additional 40 weeks, starting at Week 38 and ending with the last dose being at Week 78. Final efficacy assessments, including a pouchoscopy will be performed at Week 82.

Conditions

Pouchitis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Clinical Modified Pouchitis Disease Activity Index (mPDAI) Remission at Week 14

  Clinical (mPDAI) remission is defined as mPDAI score \<5 and a reduction of mPDAI score by \>=2 points from Baseline. The mPDAI score is calculated as a sum of two subscales based on clinical symptoms (0 to 6) and endoscopic findings (0 to 6): 1) Clinical Symptoms: Stool Frequency (0=usual postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever (temperature \>37.8 degrees celsius \[C\]) (0=Absent and 1=Present); 2) Endoscopic Inflammation Findings: Edema (0=not present to 1=present); Granularity (0=not present to 1=present); Friability (0=not present to 1=present); Loss of vascular pattern (0=not present to 1=present); Mucous exudates (0=not present to 1=present); Ulcerations (0=not present to 1=present). The total mPDAI score can range from 0 to 12. A higher mPDAI score is indicative of worse disease.

  At Week 14

Secondary Outcomes (19)

• Percentage of Participants Achieving Clinical (mPDAI) Remission at Week 34

  At Week 34

• Percentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Week 14

  At Week 14

• Percentage of Participants Achieving PDAI Remission at Week 34

  At Week 34

• Percentage of Participants Achieving Clinical (mPDAI) Response at Week 14

  At Week 14

• Percentage of Participants Achieving Clinical (mPDAI) Response at Week 34

  At Week 34

Study Arms (1)

Vedolizumab

EXPERIMENTAL

Participants will receive vedolizumab intravenous infusion based on body weight (\>=30 kg: high dose, \>15 to \<30 kg: medium dose, 10-15 kg: low dose) on Day 1, Weeks 2 and 6 during induction period and every 8 weeks (Q8W) at Weeks 14, 22 and 30 during maintenance period. Ciprofloxacin, metronidazole, vancomycin, amoxicillin-clavulanate, or rifaximin, will be administered as concomitant antibiotics, orally from Day 1 to Week 2 during induction period (unless intolerant or contraindicated) in Part 1. Participants who respond at Week 34 will proceed to Part 2 and will continue to receive vedolizumab intravenous infusions every 8 weeks from Week 38 to Week 78 throughout continued maintenance Part 2. The dose of vedolizumab used during Part 2 will be the same as the last dose administered during Week 30 of Part 1.

Drug: Vedolizumab; Drug: Concomitant Antibiotic Therapy

Interventions

Vedolizumab DRUG

Vedolizumab intravenous infusion.

Also known as: Entyvio, MLN0002, Kynteles

Vedolizumab

Concomitant Antibiotic Therapy DRUG

Ciprofloxacin, metronidazole, vancomycin, amoxicillin clavulanate or rifaximin.

Vedolizumab

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participant weighs \>=10 kg at the time of screening and first dose.
• Has active chronic pouchitis, defined by a mPDAI score \>=5 assessed using the 3-day average of participant-reported clinical symptoms prior to the screening endoscopy (that is \[ie\] video pouchoscopy with biopsy) or bowel preparation for the endoscopy and a minimum mPDAI endoscopic subscore of 2 (outside the staple or suture line) and either:
• \>=1 previous episodes of pouchitis within 1 year before the screening visit, with symptoms lasting for at least a total of 4 weeks, treated with \>=2 weeks of antibiotic or other prescription therapy (ie, other antibiotics, probiotics, immunomodulators, or anti-tumor necrosis factor \[TNFs\] within 1 year before screening). Or
• Have had an inadequate response with, or lost response to, or be intolerant to antibiotic therapy (ie, requiring maintenance antibiotic therapy taken for \>=4 weeks immediately before the baseline endoscopy visit or not able to receive or continue antibiotic treatment due to intolerance or other contraindication).
• The participant is aged 2 to 17 years, inclusive, at the time of screening and first dose.
• The participant has a history of proctocolectomy and ileal pouch-anal anastomosis (IPAA) as treatment for ulcerative colitis (UC), Crohn's disease (CD), familial adenomatous polyposis (FAP), or other underlying conditions, such as Hirschsprung's disease, for which construction of a pouch was medically indicated, completed at least 1 year before the screening visit.

You may not qualify if:

• Has symptoms believed to be predominantly due to irritable pouch syndrome.
• Has isolated cuffitis.
• Is found to have dysplasia at the screening endoscopy.
• Has mechanical complications of the pouch (for example \[e.g.\] pouch stricture or pouch fistula).
• Currently requires or has a planned surgical intervention during the study.
• Has a diverting stoma.
• Has evidence of an active infection (e.g. sepsis, cytomegalovirus \[CMV\], or listeriosis) during screening.
• Had a clinically significant infection (e.g. pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 35 days before first dose of study drug.
• Has active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 3 months of screening or during the screening period that is positive, as defined by:
• A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, or
• A TB skin test reaction \>=5 millimeter (mm). NOTE: If participant have received Bacillus Calmette-Guérin vaccine, then a QuantiFERON TB Gold test should be performed instead of the TB skin test.
• NOTE: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
• Has evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (e.g. HBsAg negative and hepatitis B antibody positive) may, however, be included.
• NOTE: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
• Has chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV Ribonucleic Acid \[RNA\]).

Sponsors & Collaborators

• Takeda: lead

Study Sites (14)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Children's Hospital Zagreb

Zagreb, 10000, Croatia

RECRUITING

Fakultni nemocnice v Motole, Pediatricka klinika 2

Prague, 150 06, Czechia

RECRUITING

Sotiria Thoracic Diseases Hospital, Dpt. of Gastroenterology, Building Z

Athens, Attica, 115 27, Greece

RECRUITING

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

RECRUITING

Istituto G Gaslini Ospedale Pediatrico IRCCS

Genova, 16147, Italy

RECRUITING

Azienda Ospedaliero Universitaria, Policlinico Gaetano Martino

Messina, 98124, Italy

RECRUITING

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli

Napoli, 80138, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, 00161, Italy

RECRUITING

IRCCS Materno Infantile Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

Instytut Pomnik-/Centrum Zdrowia dziecka

Warsaw, 04-730, Poland

RECRUITING

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 8950, Spain

RECRUITING

Hospital Universitari I Politecnic La Fe de Valencia

Valencia, 46026, Spain

RECRUITING

Related Links

• To obtain more information about this study, click this link.

MeSH Terms

Conditions

Pouchitis

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

IL (2); CR (1); ES (2); PL (1); BE (1); IT (5); CZ (1); GR (1)