Method of treating pediatric disorders with antibodies specific for alpha 4 beta 7 integrin (vedolizumab)
A technology of integrin and binding specificity, applied in a field of application in Ming Dynasty
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Embodiment 1
[0139] A phase 2 randomized double-blind dose-ranging study involving pediatric patients (male and female, 2 to 17 years inclusive) with moderately to severely active UC or CD will be used to assess the PK, Efficacy, immunogenicity, safety and tolerability. Pediatric patients will demonstrate an inadequate response, loss of response, or intolerance to at least one of the following agents: corticosteroids, immunomodulators, and / or TNF-alpha antagonist therapy. Approximately 80 pediatric subjects will be enrolled to ensure that 40 subjects weighing greater than or equal to 30 kg and 40 subjects weighing less than 30 kg will be enrolled in the study, as well as a minimum of 36 subjects with UC and a minimum of 36 subjects with CD.
[0140] The study included a four-week screening period for all subjects, a 22-week double-blind treatment period (last dose at week 14). Eligible subjects may leave the study at Week 22 and continue to receive study drug in the open-label extension ...
Embodiment 2
[0142] A Phase 2b open-label long-term extension study enrolling male and female pediatric subjects with UC or CD who initiated vedolizumab in the Phase 2 study described in Example 1 will be conducted IV treatment. The study will evaluate the long-term safety of vedolizumab administered by IV infusion. The study will also assess the effect of long-term vedolizumab IV treatment on time to major IBD-related events (hospitalization, surgery, or procedure), health-related quality of life measures, growth and developmental patterns, and exploratory efficacy measures.
[0143] Subjects will be administered vedolizumab IV every 8 weeks at the dose administered at Week 14 of the study described in Example 1 (i.e., subjects weighing less than 30 kg will receive 100 or 200 mg; subjects weighing 30 kg or more subjects will receive 150 or 300 mg). Subjects experiencing disease exacerbations while receiving low doses (ie, 100 or 150 mg) may be escalated to high doses (ie, 200 or 300 mg)...
Embodiment 3
[0145] Young monkey studies were conducted to support the expected safety profile in humans. Monkeys are approximately related to human pediatric patients (eg, 2-4 year old monkeys are related to 13 year old humans), and thus effects on <30kg human patients can be extrapolated from this study. The objectives of the study were to assess the toxicity and toxicokinetic profile of vedolizumab (also known as MLN0002) for 13 weeks when administered every other week by intravenous infusion to juvenile cynomolgus monkeys, and to assess the 12-week recovery period Recovery, persistence or progression of any effect thereafter.
[0146] MLN0002 at 0 (control, 0.9% saline), 10, 30, and 100 mg / kg in sterile water for injection was administered intravenously (approximately 30 minutes) to juvenile cynomolgus monkeys (11 to 30 minutes) every other week. 15 months old, and body weight between 1.2 and 2.1 kg at the start of the study) for 13 weeks (4 / sex / group). To assess resolution of any ef...
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