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

An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis

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.

Study Overview

• Status: Recruiting
• Conditions: Pouchitis
• Intervention / Treatment: Drug: Vedolizumab; Drug: Concomitant Antibiotic Therapy

Detailed Description

The drug being tested in this study is called vedolizumab. This study will look at the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of vedolizumab in pediatric participants with active chronic pouchitis.

The study will enroll approximately 30 participants. All the participants will be enrolled in a single treatment group to receive treatment with vedolizumab based on participant's weight mentioned as follows:

• Participants with body weight greater than or equal to (>=) 30 kilogram (kg) will receive vedolizumab, high dose
• Participants with body weight greater than (>) 15 to less than (<) 30 kg will receive vedolizumab, medium dose
• Participants with body weight 10 to 15 kg will receive vedolizumab, low dose

All participants will receive vedolizumab intravenous infusion at Day 1, and at Weeks 2, 6, 14, 22, and 30. Participants will also receive concomitant antibiotic treatment (ciprofloxacin, metronidazole, or other antibiotics) from Day 1 through Week 2. Participants with clinical response at the end of Part 1 maintenance at Week 34 will continue to Part 2 of the study and will receive vedolizumab intravenous infusion every 8 weeks from Week 38 through Week 78.

This multi-center trial will be conducted globally. The maximum overall duration of the study is up to approximately 2 years. Participants will be followed up for 18 weeks after the last dose of the study drug for safety.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Principal Investigator: Ilse Hoffman
      • Contact: Site Contact; Phone Number: +32 16 34 88 56; Email: ilse.hoffman@uzleuven.be
• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • Children's Hospital Zagreb
    • Principal Investigator: Iva Hojsak
    • Contact: Site Contact; Email: ivahojsak@gmail.com
• Czechia
  • Prague, Czechia, 150 06
    • Recruiting
    • Fakultni nemocnice v Motole, Pediatricka klinika 2
    • Principal Investigator: Katarina Mitrova
    • Contact: Site Contact; Phone Number: +420 234 770 260; Email: katarina.mitrova@gmail.com
• Greece
  • Attica
    • Athens, Attica, Greece, 115 27
      • Recruiting
      • Sotiria Thoracic Diseases Hospital, Dpt. of Gastroenterology, Building Z
      • Contact: Site Contact; Phone Number: +30210-776329, +30697606271; Email: gbamias@gmail.com
      • Principal Investigator: Georgios Bamais
• Israel
  • Jerusalem, Israel, 9103102
    • Recruiting
    • Shaare Zedek Medical Center
    • Principal Investigator: Dan Turner
    • Contact: Site Contact; Phone Number: +972-2-6666482; Email: turnerd@szmc.org.il
  • Petah Tikva, Israel, 4920235
    • Recruiting
    • Schneider Children's Medical Center of Israel
    • Principal Investigator: Dror Shouval
    • Contact: Site Contact; Phone Number: 972 3 9253673; Email: drorsh3@clalit.org.il
• Italy
  • Genova, Italy, 16147
    • Recruiting
    • Istituto G Gaslini Ospedale Pediatrico IRCCS
    • Principal Investigator: Serena Arrigo
    • Contact: Site Contact; Phone Number: 010 56363777; Email: serenaarrigo@gaslini.org
  • Messina, Italy, 98124
    • Recruiting
    • Azienda Ospedaliero Universitaria, Policlinico Gaetano Martino
    • Principal Investigator: Claudio Romano
    • Contact: Site Contact; Phone Number: +39090340066; Email: romanoc@unime.it
  • Napoli, Italy, 80138
    • Recruiting
    • AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
    • Principal Investigator: Caterina Strisciuglio
    • Contact: Site Contact; Phone Number: 0815665464; Email: caterina.strisciuglio@unicampania.it
  • Rome, Italy, 00161
    • Recruiting
    • Azienda Ospedaliero-Universitaria Policlinico Umberto I
    • Principal Investigator: Salvatore Oliva
    • Contact: Site Contact; Phone Number: +39/0649979330; Email: salvatore.oliva@uniroma1.it
  • Trieste, Italy, 34137
    • Recruiting
    • IRCCS Materno Infantile Burlo Garofolo
    • Principal Investigator: Matteo Bramuzzo
    • Contact: Site Contact; Phone Number: +39 040 3785 380; Email: matteo.bramuzzo@burlo.trieste.it
• Poland
  • Warsaw, Poland, 04-730
    • Recruiting
    • Instytut Pomnik-/Centrum Zdrowia dziecka
    • Principal Investigator: Jaroslaw Kierkus
    • Contact: Site Contact; Phone Number: 500111648; Email: j.kierkus@ipczd.pl
• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari i Politecnic La Fe de Valencia
    • Principal Investigator: Ester Donat Aliaga
    • Contact: Site Contact; Phone Number: + 34 669 840 927; Email: donat_est@gva.es
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 8950
      • Recruiting
      • Hospital Sant Joan de Déu
      • Principal Investigator: Francisco Javier Martin de Carpi
      • Contact: Site Contact; Phone Number: +34 936 009 733; Email: javier.martinc@sjd.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The participant weighs >=10 kg at the time of screening and first dose.

2. 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).
3. The participant is aged 2 to 17 years, inclusive, at the time of screening and first dose.
4. 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.

Exclusion Criteria:

The exclusion criteria are divided into 3 categories: active chronic pouchitis exclusion criteria, infectious disease exclusion criteria, and general exclusion criteria.

Active Pouchitis Exclusion Criteria:

1. Has symptoms believed to be predominantly due to irritable pouch syndrome.
2. Has isolated cuffitis.
3. Is found to have dysplasia at the screening endoscopy.
4. Has mechanical complications of the pouch (for example [e.g.] pouch stricture or pouch fistula).
5. Currently requires or has a planned surgical intervention during the study.

6. Has a diverting stoma.

   Infectious Disease Exclusion Criteria:

7. Has evidence of an active infection (e.g. sepsis, cytomegalovirus [CMV], or listeriosis) during screening.
8. Had a clinically significant infection (e.g. pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 35 days before first dose of study drug.

9. 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.

10. 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.

11. Has chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV Ribonucleic Acid [RNA]).

    NOTE: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks before baseline]).

12. Has any identified congenital or acquired immunodeficiency (e.g. common variable immunodeficiency, HIV infection, organ transplantation).
13. Has positive stool studies for ova and/or parasites or stool culture at screening visit.

14. Has positive Clostridium difficile stool test at screening visit.

    General Exclusion Criteria:

15. Is taking, has taken, or is required to take any excluded medications.
16. Has active cerebral/meningeal disease, signs/symptoms, or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
17. Has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
18. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematologic, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Vedolizumab; 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; Vedolizumab intravenous infusion.; Other Names: Entyvio; MLN0002; Kynteles; Drug: Concomitant Antibiotic Therapy; Ciprofloxacin, metronidazole, vancomycin, amoxicillin clavulanate or rifaximin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical (mPDAI) Remission at Week 34	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 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 34
Percentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Week 14	PDAI remission is PDAI score <7 and reduction of score by >=3 points from Baseline. PDAI score calculated as sum of 3 subscales based on clinical symptoms (0-6), endoscopic findings (EF) (0-6), and histologic changes (0-6): 1)Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day>postoperative usual); Rectal bleeding (0=None or rare,1=Present daily); Fecal urgency or abdominal cramps (0=None, 2=Usual),Fever (temperature>37.8 degree C) (0=Absent,1=Present);2) EF Findings: Edema (0=not present, 1=present);Granularity (0=not present, 1=present); Friability (0=not present,1=present);Loss of vascular pattern (0=not present, 1=present); Mucous exudates (0=not present, 1=present);Ulcerations (0=not present,1=present);3) Acute Histologic Inflammation: Polymorphic nuclear leukocyte infiltration (0=None, 3=Severe+crypt abscess); Ulceration per low power field (mean) (0=0% to 3=>50%). Total PDAI score ranges 0-18. Higher score means worse disease.	At Week 14
Percentage of Participants Achieving PDAI Remission at Week 34	PDAI remission is PDAI score <7 and reduction of score by >=3 points from Baseline. PDAI score calculated as sum of 3 subscales based on clinical symptoms (0-6), EF (0-6), and histologic changes (0-6): 1)Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day>postoperative usual); Rectal bleeding (0=None or rare,1=Present daily); Fecal urgency or abdominal cramps (0=None, 2=Usual),Fever (temperature>37.8 degree C) (0=Absent,1=Present);2) EF Findings: Edema (0=not present, 1=present);Granularity (0=not present, 1=present); Friability (0=not present,1=present);Loss of vascular pattern (0=not present, 1=present); Mucous exudates (0=not present, 1=present);Ulcerations (0=not present,1=present);3) Acute Histologic Inflammation: Polymorphic nuclear leukocyte infiltration (0=None, 3=Severe+crypt abscess); Ulceration per low power field (mean) (0=0% to 3=>50%). Total PDAI score ranges 0-18. Higher score means worse disease.	At Week 34
Percentage of Participants Achieving Clinical (mPDAI) Response at Week 14	Clinical (mPDAI) response is defined as a reduction in 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 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
Percentage of Participants Achieving Clinical (mPDAI) Response at Week 34	Clinical (mPDAI) response is defined as a reduction in 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 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 34
Change From Baseline in (mPDAI) Total Score at Week 14	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 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.	Baseline, Week 14
Change From Baseline in (mPDAI) Total Score at Week 34	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 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.	Baseline, Week 34
Change From Baseline in PDAI Total Score at Week 14	The PDAI score calculated as sum of 3 subscales based on clinical symptoms (0-6), endoscopic findings (0-6), and histologic changes (0-6): 1)Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day>postoperative usual); Rectal bleeding (0=None or rare,1=Present daily); Fecal urgency or abdominal cramps (0=None, 2=Usual),Fever (temperature>37.8 degree C) (0=Absent,1=Present); 2) Endoscopic Findings: Edema (0=not present, 1=present);Granularity (0=not present, 1=present); Friability (0=not present,1=present);Loss of vascular pattern (0=not present, 1=present); Mucous exudates (0=not present, 1=present);Ulcerations (0=not present,1=present);3) Acute Histologic Inflammation: Polymorphic nuclear leukocyte infiltration (0=None, 3=Severe + crypt abscess); Ulceration per low power field (mean) (0=0 percentage [%] to 3=>50%). Total PDAI score ranges from 0-18. Higher score means worse disease.	Baseline, Week 14
Change From Baseline in PDAI Total Score at Week 34	The PDAI score calculated as sum of 3 subscales based on clinical symptoms (0-6), endoscopic findings (0-6), and histologic changes (0-6): 1)Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day>postoperative usual); Rectal bleeding (0=None or rare,1=Present daily); Fecal urgency or abdominal cramps (0=None, 2=Usual),Fever (temperature>37.8 degree C) (0=Absent,1=Present); 2) Endoscopic Findings: Edema (0=not present, 1=present);Granularity (0=not present, 1=present); Friability (0=not present,1=present);Loss of vascular pattern (0=not present, 1=present); Mucous exudates (0=not present, 1=present);Ulcerations (0=not present,1=present);3) Acute Histologic Inflammation: Polymorphic nuclear leukocyte infiltration (0=None, 3=Severe + crypt abscess); Ulceration per low power field (mean) (0=0 percentage [%] to 3=>50%). Total PDAI score ranges from 0-18. Higher score means worse disease.	Baseline, Week 34
Change From Baseline in PDAI Clinical Symptoms Subscore at Week 14	The PDAI Clinical Symptoms subscore is a sum of scores (0 to 6) from findings for stool frequency (0=usual to postoperative stool frequency to 2=3 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 degree C) (0=Absent to 1=Present). Higher scores are indicative of worse disease.	Baseline, Week 14
Change From Baseline in PDAI Clinical Symptoms Subscore at Week 34	The PDAI Clinical Symptoms subscore is a sum of scores (0 to 6) from findings for stool frequency (0=usual to postoperative stool frequency to 2=3 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 degree C) (0=Absent to 1=Present). Higher scores are indicative of worse disease.	Baseline, Week 34
Change From Baseline in PDAI Endoscopic Subscore at Week 14	The PDAI Endoscopic Inflammation subscore is a sum of scores (0 to 6) from findings for 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). Higher scores are indicative of worse disease.	Baseline, Week 14
Change From Baseline in PDAI Endoscopic Subscore at Week 34	The PDAI Endoscopic Inflammation subscore is a sum of scores (0 to 6) from findings for 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). Higher scores are indicative of worse disease.	Baseline, Week 34
Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Week 14	The PDAI Acute Histologic Inflammation subscore is a sum score (0 to 6) from findings for Polymorphic nuclear leukocyte infiltration (0=None to 3=Severe + crypt abscess); Ulceration per low power field (mean) (0=0% to 3=>50%). Higher scores are indicative of worse disease.	Baseline, Week 14
Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Week 34	The PDAI Acute Histologic Inflammation subscore is a sum score (0 to 6) from findings for Polymorphic nuclear leukocyte infiltration (0=None to 3=Severe + crypt abscess); Ulceration per low power field (mean) (0=0% to 3=>50%). Higher scores are indicative of worse disease.	Baseline, Week 34
EuroQol- 5 Dimension for Youth (EQ-5D-Y) Index Scores and Visual Analogue Scale (VAS) at Week 14	The EQ-5D-Y (Proxy Version 1.0) is composed of two sections. The first section contains one question for each of the five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Participants select from three response levels (no problems, some problems, a lot of problems) for each dimension. A health state profile score can be calculated from the responses on these five dimensions. The index score ranges from 0 (0 indicating a health state equivalent to death) to 1 (indicating full health). Higher scores demonstrate higher health utility. The second section includes a VAS (EuroQol [EQ] VAS). The scale is scored from 0 (the worst) to 100 (the best imaginable health). The reference to a high score indicates a better outcome of quality of life.	At Week 14
EQ-5D-Y Index Scores and VAS at Week 34	The EQ-5D-Y (Proxy Version 1.0) is composed of two sections. The first section contains one question for each of the five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Participants select from three response levels (no problems, some problems, a lot of problems) for each dimension. A health state profile score can be calculated from the responses on these five dimensions. The index score ranges from 0 (0 indicating a health state equivalent to death) to 1 (indicating full health). Higher scores demonstrate higher health utility. The second section includes a VAS (EQ VAS). The scale is scored from 0 (the worst) to 100 (the best imaginable health). The reference to a high score indicates a better outcome of quality of life.	At Week 34
Change From Baseline in the EQ-5D-Y Index Scores and VAS at Week 14	The EQ-5D-Y (Proxy Version 1.0) is composed of two sections. The first section contains one question for each of the five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Participants select from three response levels (no problems, some problems, a lot of problems) for each dimension. A health state profile score can be calculated from the responses on these five dimensions. The index score ranges from 0 (0 indicating a health state equivalent to death) to 1 (indicating full health). Higher scores demonstrate higher health utility. The second section includes a VAS (EQ VAS). The scale is scored from 0 (the worst) to 100 (the best imaginable health). The reference to a high score indicates a better outcome of quality of life.	Baseline, Week 14
Change From Baseline in the EQ-5D-Y Index Scores and VAS at Week 34	The EQ-5D-Y (Proxy Version 1.0) is composed of two sections. The first section contains one question for each of the five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Participants select from three response levels (no problems, some problems, a lot of problems) for each dimension. A health state profile score can be calculated from the responses on these five dimensions. The index score ranges from 0 (0 indicating a health state equivalent to death) to 1 (indicating full health). Higher scores demonstrate higher health utility. The second section includes a VAS (EQ VAS). The scale is scored from 0 (the worst) to 100 (the best imaginable health). The reference to a high score indicates a better outcome of quality of life.	Baseline, Week 34

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Enteritis; Ileitis; Ileal Diseases; Pouchitis; Anti-Infective Agents; Gastrointestinal Agents; vedolizumab
• Other Study ID Numbers: Vedolizumab-3041; 2023-504773-20-00 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No