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

NCT01532570 | Completed Phase 3 Results

• 1 other identifier: TA-650-23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Behcet's disease; intestinal Behcet's disease; neuro-Behcet's disease; vascular Behcet's disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response at Week 30

  We defined the patient who met the following criteria as the complete responders. The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, Computed tomography (CT) or Positron emission tomography/Computed tomography (PET/CT) findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0.

  Week 30

Secondary Outcomes (14)

• Percentage of Participants With Complete Response at Week 14 and 54

  Week 14, Week 54

• Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD

  Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54

• Imaging Findings:Endoscopic Examination for Intestinal BD

  Week 14, Week 30, Week 54

• Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD

  Week 14, Week 30, Week 54

• Imaging Findings: Brainstem MRI for Chronic Neuro-BD

  Week 14, Week 30, Week 54

Study Arms (1)

TA-650

EXPERIMENTAL

Drug: TA-650

Interventions

TA-650 DRUG

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.

TA-650

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed with the complete or incomplete type of Behcet's disease according to "The criteria for a diagnosis of Behcet's disease, Ministry of Health, Labour and Welfare in Japan (partially revised in 2010)"
• Patients who have special lesions despite having received conventional treatments for special lesions, or patients who cannot receive conventional treatments due to intolerability.
• Patients who have clinical symptoms associated with each special lesions.

You may not qualify if:

• Patients with intestinal, neuro-, vascular Behcet's disease in whom a differential diagnosis of each Behcet's disease from other conditions．
• Patients who have received treatment with infliximab within 1 year before enrollment for another purpose than treating special lesions; or patients whose previous treatment with infliximab was discontinued due to adverse events.
• Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving acquirement.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (6)

Investigational site

Chūbu, Japan

Location

Investigational site

Hokkaido, Japan

Location

Investigational site

Kanto, Japan

Location

Investigational site

Kinki, Japan

Location

Investigational site

Kyusyu, Japan

Location

Investigational site

Tōhoku, Japan

Location

Related Publications (1)

• Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, Kondo K, Ishigatsubo Y. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study. Medicine (Baltimore). 2016 Jun;95(24):e3863. doi: 10.1097/MD.0000000000003863.

  PMID: 27310969 RESULT

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Yoshiaki Ishigatsubo, MD, Ph.D

  Yokohama City University Graduate School of Medicine

  STUDY DIRECTOR

• Toshifumi Hibi, MD

  Kitasato University Kitasato Institute Hospital

  STUDY DIRECTOR

• Shunsei Hirohata, MD

  Kitasato University School of Medicine

  STUDY DIRECTOR

• Kazuoki Kondo, MD

  Mitsubihsi Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 14, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 7, 2026
• Results First Posted: December 16, 2016

Record last verified: 2025-12

Locations

JP (6)