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Completed

NCT Number: NCT01532570

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

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.

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Key information

Conditions

Behcet's Disease Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Mouth Diseases Neuro-Behcet's Disease Panuveitis Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational site, Chūbu, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants With Complete Response at Week 30

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants With Complete Response at Week 14 and 54

    Time frame: Week 14, Week 54

    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, CT or PET/CT findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0.

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

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

    The VAS evaluation measured using the "General VAS evaluation From" and the range is from 0 to 100 mm. The best condition per one week before evaluation visit for the clinical symptoms associated with each BD is defined as "0" and the worst condition is defined as "100".

    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  3. Imaging Findings:Endoscopic Examination for Intestinal BD

    Time frame: Week 14, Week 30, Week 54

    The investigator assessed the length of the major axis of the principal intestinal ulcer at day of evaluation and scored in accordance with the following categories, "Healed/scarred, Reduced to =< 25%, Reduced to > 25% to =< 50% or Reduced to > 50%/no change/increased" in the principal intestinal ulcer compared to size at Week 0.

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

    Time frame: Week 14, Week 30, Week 54

    Changes in brain MRI findings were scored at day of evaluation, in accordance with the following categories, "No high-intensity areas, Reduction or No changes/increase" in the size of high-intensity areas compared to Week 0.

  5. Imaging Findings: Brainstem MRI for Chronic Neuro-BD

    Time frame: Week 14, Week 30, Week 54

    Changes in brainstem MRI findings were scored at day of evaluation, in accordance with the following categories, "Unchanged or Reduced" in the brainstem area compared to Week 0.

  6. Imaging Findings: CT, PET/CT for Vascular-BD

    Time frame: Week 14, Week 30, Week 54

    Changes in CT or PET/CT findings were scored at day of evaluation, in accordance with the following categories, "Improves, Unchanged or Worsened" by comparison with those at Week 0.

  7. Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD

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

    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  8. Concentration of Inflammatory Biomarker (CRP) of Vascular BD

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

    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  9. Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD

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

    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  10. Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD

    Time frame: Week 0, Week 14, Week 30, Week 54

    The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.

  11. Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD

    Time frame: Week 0, Week 14, Week 30, Week 54

  12. The Number of Improved Intestinal BD Patients From Baseline

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

    The investigator assessed clinical symptoms associated with intestinal BD in one week before the day of evaluation as " No symptom, Very slightly poor, Slightly poor, Poor or Extremely poor".

    We calculated improved patients in comparison with those for Week 0.

  13. Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients

    Time frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54

    The investigator assessed the clinical symptoms associated with neuro-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as "No symptom, Improved, Unchanged or Worsened".

  14. Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients

    Time frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54

    The investigator assessed the clinical symptoms associated with vascular-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as "No symptom, Improved, Unchanged or Worsened".

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2012
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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