Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Pediatric Crohn's Disease

Treatments: Drug: TA-650

Study type: Interventional

Funder types: Industry

Identifiers

NCT01580670

TA-650-20

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.

Full description

This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.

Enrollment: 14 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have been diagnosed as Crohn's disease at least 3 months prior to screening.
• Have active Crohn's disease despite adequate conventional therapy.

Exclusion criteria

• Patients with severe intestinal strictures (strictures which may affect the number of defecations, etc., or dilation of the colon or strictures in the proximal small bowel observed on barium radiograph, or strictures precluding the insertion of endoscope), a diagnosis of short bowel syndrome, or previous stoma surgery.
• Patients who have a history of treatment with infliximab, or biological products (anti-TNFα agents and anti-IL-6 agents, etc.).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

TA-650

Experimental group

Description:

Responder criteria: Case where PCDAI score on the evaluation day was decreased by at least 15 points from that in the screening period and was ≤30. Criteria for dose-increasing: When either of the following 2 items was satisfied after Week 14, the relevant patient would be considered to satisfy the criteria for dose increasing to 10 mg/kg. 1. PCDAI score on the evaluation day was increased by at least 15 points compared to the lowest PCDAI score observed at Week 2, 6 or 10 2. PCDAI score on the evaluation day exceeds 30

Treatment:

Drug: TA-650