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

NCT01532570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-07

Study results available
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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

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.

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Yoshiaki Ishigatsubo, MD, Ph.D · Yokohama City University Graduate School of Medicine

  • Toshifumi Hibi, MD · Kitasato University Kitasato Institute Hospital

  • Shunsei Hirohata, MD · Kitasato University School of Medicine

  • Kazuoki Kondo, MD · Mitsubihsi Tanabe Pharma Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01532570 on ClinicalTrials.gov