Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official 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|
- Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 5 years ]An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
- Time to Major Inflammatory Bowel Disease (IBD) - Related Events [ Time Frame: Baseline up to 5 years ]Major IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis (UC) and Crohn's disease (CD).
- Changes from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life.
- Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]Height velocity (cm/year) is the change in height per year.
- Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
- Change from Baseline in Weight at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]
- Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 5 years [ Time Frame: Baseline up to 5 years ]BMI = Weight (in kilograms)/height^2 (in meters).
- Percentage of Participants Achieving Tanner Stage V Scale [ Time Frame: Baseline up to 5 years ]Tanner Stage Evaluation is a scale used to evaluate growth parameters standardized for age, sex, and pubertal development. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Tanner stage is assessed at or before age 16 years for females or 17 years for males.
|Anticipated Study Start Date:||November 10, 2017|
|Estimated Study Completion Date:||June 14, 2025|
|Estimated Primary Completion Date:||February 8, 2025 (Final data collection date for primary outcome measure)|
Experimental: Vedolizumab High Dose Group
Participants with UC or CD having baseline weight of ≥30 kg will receive Vedolizumab 300 mg and participants with UC or CD having baseline weight of <30 kg will receive Vedolizumab 200 mg, intravenous (IV) infusion every 8 weeks for up to 5 years.
Vedolizumab intravenous infusion
Experimental: Vedolizumab Low Dose Group
Participants with UC or CD having baseline weight of ≥30 kg will receive Vedolizumab 150 mg and participants with UC or CD having baseline weight of <30 kg will receive Vedolizumab 100 mg IV infusion every 8 weeks for up to 5 years.
Vedolizumab intravenous infusion
The drug being tested in this study is called Vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD.
This study will look at the long-term safety profile in participants who take vedolizumab. Participants will roll over from the randomized double blind study (MLN0002-2003) to the Vedolizumab-2005 Open Label Extension (OLE) study maintaining the dose at study entry and escalating the dose at disease worsening.
The dosing regimen selected for the long-term OLE study is intended to maintain clinical response at the lowest possible exposure.
At the discretion of the investigator, participants receiving the low dose (150 or 100 mg) of vedolizumab IV may be escalated to the high dose (300 or 200 mg) if the participants demonstrate disease worsening at 2 consecutive visits (scheduled or unscheduled).
Participants who experience continued disease worsening during the OLE study despite being administered vedolizumab 300 or 200 mg every 8 weeks (Q8W) will be discontinued from the study.
Study duration is expected to be up to 5 years, depending on the enrollment rate in the previous randomized double blind study (MLN0002-2003).
Please refer to this study by its ClinicalTrials.gov identifier: NCT03196427
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|Study Director:||Medical Monitor Clinical Science||Takeda|