NCT01532570

Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions

To Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Patients With Behcet's Disease ( BD ) With Special Lesions After the Administration of TA-650

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650 in patients with Behcet's disease ( BD ) with special lesions after the administration of TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to week 46.

Conditions

• Behcet's Disease
• Behcet Syndrome
• Neuro-Behcet's Disease

Interventions

Type	Name	Description
DRUG	TA-650	TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-02-14
• Last updated: 2026-01-07
• Results posted: 2016-12-16

Locations

6 sites across 1 country: Japan