Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT03196427
• Date of registration: 20/06/2017
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
• Scientific title: A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
• Date of first enrolment: July 30, 2018
• Target sample size: 59
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03196427
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, France, Hungary, Israel, Netherlands, Poland, Ukraine, United Kingdom, United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time
of randomization for Study MLN0002-2003.

(Note: A participant remains eligible to participate in this study after they reach 18
years of age if they continue to meet the inclusion criteria and do not meet any
exclusion criteria.)

2. Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as
defined by a reduction of partial Mayo score of >=2 points and >=25% from Baseline, or
a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of >=20 points
from baseline for participants with UC; or a reduction of the CDAI as defined by a
>=70-point decrease from Baseline or a decrease of Pediatric Crohn's Disease Activity
Index (PCDAI) of >=15 points for participants with CD.

3. May be receiving a therapeutic dose of the following drugs:

- Oral 5-aminosalicylic acid (5-ASA) compounds.

- Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than
or equal to [<=] 50 milligram per day [mg/day]) provided the participant was
receiving this medication during prior participation in MLN0002-2003.

- Topical (rectal) treatment with 5-ASA or corticosteroids.

- Probiotics (example, Saccharomyces boulardii).

- Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of
chronic diarrhea.

- Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).

- Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the
participant was receiving this medication during prior participation in
MLN0002-2003.

4. The participant's vaccinations are up to date as per inclusion criteria number 10 in
MLN0002-2003.

Exclusion Criteria:

1. Is female and is lactating or pregnant.

2. Has hypersensitivity or allergies to vedolizumab or any of its excipients.

3. Has withdrawn from Study MLN0002-2003.

4. Has developed any new unstable or uncontrolled cardiovascular, heart failure moderate
to severe (New York Class Association III or IV), pulmonary, hepatic, renal,
gastrointestinal (GI), genitourinary, hematological, coagulation, immunological,
endocrine/metabolic, neurological, or other medical disorder that, in the opinion of
the investigator, would confound the study results or compromise participant safety.

5. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom
checklist prior to the administration of the first dose of study drug.

6. Currently requires major surgical intervention for UC or CD (example, bowel
resection), or is anticipated to require major surgical intervention for UC or CD
during the study.

7. Has other serious comorbidities that will limit his or her ability to complete the
study.



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Ulcerative Colitis

Intervention(s)

Drug: Vedolizumab

Primary Outcome(s)

Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Baseline up to approximately 8 years]

Secondary Outcome(s)

Change from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 8 Years [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants Achieving Tanner Stage V [Time Frame: Baseline up to approximately 8 years]

Time to Major Inflammatory Bowel Disease (IBD) - Related Events [Time Frame: Baseline up to approximately 8 years]

Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 8 Years [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants With CD Meeting Clinical Response Based on 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 32 [Time Frame: Week 32]

Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 8 Years [Time Frame: Baseline up to approximately 8 years]

Change from Baseline in Weight at Week 24 and Every 24 Weeks, Thereafter up to 8 Years [Time Frame: Baseline up to approximately 8 years]

Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 8 Years [Time Frame: Baseline up to approximately 8 years]

Percentage of Participants With UC Meeting Clinical Response Based on Complete Mayo Score at Week 32 [Time Frame: Week 32]

Secondary ID(s)

U1111-1176-5741

17/NE/0258

MOH_2017-09-18_000649

2017-002182-21

Vedolizumab-2005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda Development Center Americas, Inc.