Behcet's DiseasePhase 3NCT01532570

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

A Phase 3 study testing TA-650 in people with Behcet's Disease and Behcet Syndrome, run by Tanabe Pharma Corporation at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 to 75 years
Conditions the study is for: Behcet's Disease, Behcet Syndrome, Neuro-Behcet's Disease
What is being tested?: TA-650
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 6 sitesJapan
Study dates: Jan 2012to May 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Japan6 sites

Investigational site
Chūbu
Investigational site
Hokkaido
Investigational site
Kanto
Investigational site
Kinki
Investigational site
Kyusyu
Investigational site
Tōhoku

Other trials in Japan

About this study

Official 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

Conditions: Behcet's Disease, Behcet Syndrome, Neuro-Behcet's Disease
Being tested: TA-650
Keywords: Behcet's disease, intestinal Behcet's disease, neuro-Behcet's disease, vascular Behcet's disease
Medical subject headings: Behcet Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TA-650Drug
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.

Study groups in NCT01532570
Study group	Role	What they receive
TA-650	Experimental	Not described Receives: Drug: TA-650

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 30

Secondary outcomes (14)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, Week 14, Week 30, Week 54
Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD
Measured: 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.
Measured: 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".
Measured: 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".
Measured: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012May 2014

First posted14 Feb 2012 (estimated)
Study startJan 2012
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Behcet's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01532570
Sponsor's protocol ID: TA-650-23
Status last verified: Dec 2025
First submitted: 6 Feb 2012
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27310969

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01532570
Acronym / sponsor ID: TA-650-23
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 14 Feb 2012 (estimated)
Results: Posted 16 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TA-650	Experimental	Drug: TA-650

Who may qualify

Ages: 16 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TA-650TA-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.	Drug	TA-650

Primary outcome

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.

14 secondary outcomes

Percentage of Participants With Complete Response at Week 14 and 54
Time frame: Week 14, Week 54
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
Imaging Findings:Endoscopic Examination for Intestinal BD
Time frame: Week 14, Week 30, Week 54
Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD
Time frame: Week 14, Week 30, Week 54
Imaging Findings: Brainstem MRI for Chronic Neuro-BD
Time frame: Week 14, Week 30, Week 54
Imaging Findings: CT, PET/CT for Vascular-BD
Time frame: Week 14, Week 30, Week 54
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
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
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
Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD
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
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
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
Time frame: Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54

Results and safety

Results posted to the registry on 16 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intestinal BD	11	10
Acute Neuro-BD	2	1
Chronic Progressive Neuro-BD	1	1
Vascular BD	4	4

Primary outcome: Percentage of Participants With Complete Response at Week 30

Time frame: Week 30. Number. Unit: percentage of Complete Responders

Measure	Intestinal BD n = 11	Acute Neuro-BD n = 2	Chronic Progressive Neuro-BD n = 1	Vascular BD n = 4
Value	54.5	0	100	100

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TA-650	2 of 18 (11.1%)	17 of 18 (94.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27310969Hibi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoshiaki Ishigatsubo, MD, Ph.D study director

Yokohama City University Graduate School of Medicine

Toshifumi Hibi, MD study director

Kitasato University Kitasato Institute Hospital

Shunsei Hirohata, MD study director

Kitasato University School of Medicine

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TA-650 in people with Behcet's Disease and Behcet Syndrome, run by Tanabe Pharma Corporation at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Complete Response at Week 30 (time frame: Week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01532570, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.