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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
Investigational site
Chūbu, Japan
Investigational site
Hokkaido, Japan
Investigational site
Kanto, Japan
Investigational site
Kinki, Japan
Investigational site
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.
Time frame: Week 30
Percentage of Participants With Complete Response at Week 14 and 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.
Time frame: Week 14, Week 54
Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD
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.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Imaging Findings:Endoscopic Examination for Intestinal BD
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.
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Kyusyu, Japan
Investigational site
Tōhoku, Japan
Time frame: Week 14, Week 30, Week 54
Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
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.
Time frame: Week 14, Week 30, Week 54
Imaging Findings: Brainstem MRI for Chronic Neuro-BD
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.
Time frame: Week 14, Week 30, Week 54
Imaging Findings: CT, PET/CT for Vascular-BD
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.
Time frame: Week 14, Week 30, Week 54
Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD
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.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Concentration of Inflammatory Biomarker (CRP) of Vascular BD
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.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD
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.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
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.
Time frame: Week 0, Week 14, Week 30, Week 54
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Time frame: Week 0, Week 14, Week 30, Week 54
The Number of Improved Intestinal BD Patients From Baseline
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.
Time frame: Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients
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".
Time frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54
Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients
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".
Time frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54