Plaque PsoriasisPhase 3NCT01680159

A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis

A Phase 3 study testing TA-650 in people with Plaque Psoriasis and Psoriatic Arthritis, run by Tanabe Pharma Corporation at 7 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 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter. Read more about this study

Who is it for?: Ages 16 to 75 years
Conditions the study is for: Plaque Psoriasis, Psoriatic Arthritis, Pustular Psoriasis (Excluding a Localized)
What is being tested?: TA-650
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 7 sitesJapan
Study dates: Jul 2012to Mar 2015
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 have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.
Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter.

Who cannot join

Patients who have guttate psoriasis.
Patients who have drug-induced psoriasis
Patients who have previously used any other biological products than infliximab.
Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization.
Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections
Female patients who are pregnant, breast-feeding, or possibly pregnant.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

Investigational site
Chūbu
Investigational site
Chugoku
Investigational site
Hokkaido
Investigational site
Kanto
Investigational site
Kinki
Investigational site
Kyushu
Investigational site
Tōhoku

Other trials in Japan

About this study

Read the detailed description

Patients with plaque psoriasis or psoriatic arthritis:

Screening Period: TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours.
Increased Dose Period: If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours.

Patients with pustular psoriasis or psoriatic erythroderma:

TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours.

Conditions: Plaque Psoriasis, Psoriatic Arthritis, Pustular Psoriasis (Excluding a Localized), Psoriatic Erythroderma
Being tested: TA-650
Keywords: Infliximab, REMICADE, TA-650, psoriasis
Medical subject headings: Arthritis, Psoriatic, Psoriasis

What participants receive

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

TA-650Drug

Study groups in NCT01680159
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 Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.
When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.
As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).
The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.
Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period

Secondary outcomes (4)

Psoriasis Area and Severity Index (PASI) Score
Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.
Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.
0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe
Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
From 0 (best) to 100 (worst)
Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Assessment of Severity (Only for Patients With Pustular Psoriasis)
From 0 (best) to 17 (worst)
Measured: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period

Timeline

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

Jul 2012Mar 2015

First posted7 Sep 2012 (estimated)
Study startJul 2012
Primary completionMar 2015
Study completionMar 2015

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.
Other trials for Plaque PsoriasisStudies 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: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01680159
Sponsor's protocol ID: TA-650-24
Status last verified: Dec 2025
First submitted: 28 Aug 2012
Last updated: 8 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
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Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
ClinicalTrials.gov ID: NCT01680159
Acronym / sponsor ID: TA-650-24
Conditions: Plaque Psoriasis, Psoriatic Arthritis, Pustular Psoriasis (Excluding a Localized), Psoriatic Erythroderma
Keywords: Infliximab, REMICADE, TA-650, psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 7 Sep 2012 (estimated)
Results: Posted 13 Mar 2017

Clinical summary

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

Detailed description

Patients with plaque psoriasis or psoriatic arthritis:

Screening Period: TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours.
Increased Dose Period: If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours.

Patients with pustular psoriasis or psoriatic erythroderma:

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 (2 listed)

Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.
Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter.

Key exclusion criteria (6 listed)

Patients who have guttate psoriasis.
Patients who have drug-induced psoriasis
Patients who have previously used any other biological products than infliximab.
Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization.
Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections

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-650	Drug	TA-650

Primary outcome

Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.

4 secondary outcomes

Psoriasis Area and Severity Index (PASI) Score
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period

Results and safety

Results posted to the registry on 13 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TA-650	46	39

Primary outcome: Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score

Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period. Number. Unit: percentage of participants

Measure	Overall n = 51	Plaque Psoriasis n = 31	Psoriatic Arthritis n = 8	Pustular Psoriasis n = 7	Psoriatic Erythroderma n = 5
Week 0 (n=51,31,8,7,5)	0.0	0.0	0.0	0.0	0.0
Week 4 (n=51,31,8,7,5)	13.7	16.1	0.0	0.0	40.0
Week 8 (n=50,31,8,6,5)	18.0	16.1	0.0	33.3	40.0
Week 12 (n=49,30,8,6,5)	36.7	40.0	0.0	50.0	60.0
Week 16 (n=48,29,8,6,5)	31.3	34.5	0.0	50.0	40.0
Week 20 (n=46,28,7,6,5)	50.0	53.6	14.3	50.0	80.0
Week 24 (n=45,27,7,6,5)	40.0	40.7	42.9	33.3	40.0
Week 28 (n=44,26,7,6,5)	63.6	69.2	28.6	83.3	60.0

4 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（Normal Dose Period）Overall	0 of 46 (0%)	24 of 46 (52.2%)	Not reported
TA-650（Normal Dose Period）Plaque Psoriasis	0 of 36 (0%)	19 of 36 (52.8%)	Not reported
TA-650（Normal Dose Period）Psoriatic Arthritis	0 of 10 (0%)	5 of 10 (50%)	Not reported
TA-650（Dose Escalation Period）Overall	5 of 51 (9.8%)	47 of 51 (92.2%)	Not reported
TA-650（Dose Escalation Period）Plaque Psoriasis	4 of 31 (12.9%)	30 of 31 (96.8%)	Not reported
TA-650（Dose Escalation Period）Psoriatic Arthritis	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
TA-650（Dose Escalation Period）Pustular Psoriasis	1 of 7 (14.3%)	6 of 7 (85.7%)	Not reported
TA-650（Dose Escalation Period）Psoriatic Erythroderma	0 of 5 (0%)	4 of 5 (80%)	Not reported
TA-650（Entire Evaluation Period）Plaque Psoriasis	4 of 36 (11.1%)	34 of 36 (94.4%)	Not reported
TA-650（Entire Evaluation Period）Psoriatic Arthritis	0 of 10 (0%)	9 of 10 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Plaque Psoriasis

Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
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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.

Hideshi Torii, MD study director

Social Insurance Central General Hospital

Kazuoki Kondo, MD study director

Mitsubihsi Tanabe Pharma Corporation

Hidemi Nakagawa, MD study chair

The Jikei University School of Medicine

7 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 Plaque Psoriasis and Psoriatic Arthritis, run by Tanabe Pharma Corporation at 7 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 2 inclusion and 6 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 8 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 7 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 13 Mar 2017). 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 Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score (time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period). 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 NCT01680159.

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 8 Jan 2026.