An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease

Phase 1

Conditions: lcerative Colitis or Crohn’s Disease
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2017-002182-21-FR

Lead Sponsor: Takeda Development Centre Europe, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

-The subject is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of their first dose of study drug in Study MLN0002-2003. (Note: A subject 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.)
-The subject completed Study MLN0002-2003 and in the opinion of the investigator is expected to benefit from continued vedolizumab treatment.
-Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, or other known risk factor must be up-to-date on colorectal cancer surveillance.
-The subject may be receiving a therapeutic dose of the following drugs:
– Oral 5-aminosalicylic (5-ASA) compounds.
– Oral corticosteroid therapy (prednisone or equivalent steroid at a dose =50 mg/day, budesonide at a dos =9 mg/day).
– Topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories.
– Probiotics (eg, Saccharomyces boulardii).
– Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
– Antibiotics used for treatment of CD (eg, ciprofloxacin, metronidazole).
– Azathioprine, 6-mercaptopurine, or methotrexate provided the subject was receiving this medication during prior participation in Study MLN0002-2003.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-The subject is female and is lactating or pregnant.
-The subject has hypersensitivity or allergies to vedolizumab or any of its excipients.
-The subject has withdrawn from Study MLN0002-2003.
-The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, 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 subject safety.
-The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
-The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
-The subject has other serious comorbidities that will limit their ability to complete the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To determine the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.<br>;Secondary Objective: -To determine the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel disease (IBD)-related events (hospitalizations, surgeries, and procedures) in pediatric subjects with UC or CD.<br>-To examine the effect of long-term vedolizumab IV treatment on health-related quality-of- life measurements in pediatric subjects with UC or CD.<br>-To determine the effect of long-term vedolizumab IV treatment on patterns of growth and development in pediatric subjects with UC or CD.;Primary end point(s): The primary endpoint for this study is percentage of subjects with treatment-emergent adverse events (TEAEs).<br><br>;Timepoint(s) of evaluation of this end point: Monitored throughout the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints for this study are:<br>- Time to major IBD-related events (hospitalizations, surgeries, or procedures).<br>- Changes from Baseline in IMPACT-III (where translations are available) total and subscale scores at Week 24 and every 24 weeks, thereafter.<br>- Height velocity at Week 48 and every 48 weeks, thereafter.<br>- Change from Baseline in height, weight, and body mass index (BMI) at Week 24 and every 24 weeks, thereafter.<br>- Percentage of subjects achieving Tanner stage V at or before age 16 years (females) or 17 years (males).;Timepoint(s) of evaluation of this end point: Monitored throughout the study

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