Trial · NCT01680159
A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
NCT01680159, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2017-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis. Trials, record NCT01680159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01680159
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
- NCT number
- NCT01680159
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 51 participants, actual
- Lead sponsor
- Tanabe Pharma Corporation
- Conditions
- Plaque Psoriasis, Psoriatic Arthritis, Pustular Psoriasis (Excluding a Localized), Psoriatic Erythroderma
- Interventions
- TA-650
- First posted
- 2012-09-07
- Last updated
- 2026-01-08
- Results first posted
- 2017-03-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | 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. |
| Secondary | Psoriasis Area and Severity Index (PASI) Score | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | 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. |
| Secondary | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | 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 |
| Secondary | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | From 0 (best) to 100 (worst) |
| Secondary | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | From 0 (best) to 17 (worst) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | percentage of participants | NUMBER | |
| SECONDARY | Psoriasis Area and Severity Index (PASI) Score | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | units on a scale | MEDIAN | |
| SECONDARY | Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | percentage of participants | NUMBER | |
| SECONDARY | Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | mm | MEDIAN | |
| SECONDARY | Assessment of Severity (Only for Patients With Pustular Psoriasis) | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group143
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Overall | Week 0 (n=51,31,8,7,5) | 0.0 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Plaque Psoriasis | Week 0 (n=51,31,8,7,5) | 0.0 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Psoriatic Arthritis | Week 0 (n=51,31,8,7,5) | 0.0 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Pustular Psoriasis | Week 0 (n=51,31,8,7,5) | 0.0 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Psoriatic Erythroderma | Week 0 (n=51,31,8,7,5) | 0.0 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Overall | Week 4 (n=51,31,8,7,5) | 13.7 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Plaque Psoriasis | Week 4 (n=51,31,8,7,5) | 16.1 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Psoriatic Arthritis | Week 4 (n=51,31,8,7,5) | 0.0 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Pustular Psoriasis | Week 4 (n=51,31,8,7,5) | 0.0 | percentage of participants | |
| Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score | Psoriatic Erythroderma | Week 4 (n=51,31,8,7,5) | 40.0 | percentage of participants |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening Period | STARTED | TA-650 | 46 | |
| Screening Period | COMPLETED | TA-650 | 39 | |
| Screening Period | NOT COMPLETED | TA-650 | 7 | |
| Increased Dose Period | STARTED | TA-650 | 51 | |
| Increased Dose Period | COMPLETED | TA-650 | 43 | |
| Increased Dose Period | NOT COMPLETED | TA-650 | 8 |
Source ClinicalTrials.gov
Adverse events990
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | TA-650（Normal Dose Period）Overall | 0 | 46 | |
| other | Bronchitis | Infections and infestations | TA-650（Normal Dose Period）Plaque Psoriasis | 0 | 36 | |
| other | Bronchitis | Infections and infestations | TA-650（Normal Dose Period）Psoriatic Arthritis | 0 | 10 | |
| other | Bronchitis | Infections and infestations | TA-650（Dose Escalation Period）Overall | 1 | 51 | |
| other | Bronchitis | Infections and infestations | TA-650（Dose Escalation Period）Plaque Psoriasis | 1 | 31 | |
| other | Bronchitis | Infections and infestations | TA-650（Dose Escalation Period）Psoriatic Arthritis | 0 | 8 | |
| other | Bronchitis | Infections and infestations | TA-650（Dose Escalation Period）Pustular Psoriasis | 0 | 7 | |
| other | Bronchitis | Infections and infestations | TA-650（Dose Escalation Period）Psoriatic Erythroderma | 0 | 5 | |
| other | Bronchitis | Infections and infestations | TA-650（Entire Evaluation Period）Plaque Psoriasis | 1 | 36 | |
| other | Bronchitis | Infections and infestations | TA-650（Entire Evaluation Period）Psoriatic Arthritis | 0 | 10 |
1 to 10 of 990Source ClinicalTrials.gov
See all 990 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TA-650（Normal Dose Period）Overall | ||
| Total, all-cause mortality | TA-650（Normal Dose Period）Plaque Psoriasis | ||
| Total, all-cause mortality | TA-650（Normal Dose Period）Psoriatic Arthritis | ||
| Total, all-cause mortality | TA-650（Dose Escalation Period）Overall | ||
| Total, all-cause mortality | TA-650（Dose Escalation Period）Plaque Psoriasis | ||
| Total, all-cause mortality | TA-650（Dose Escalation Period）Psoriatic Arthritis | ||
| Total, all-cause mortality | TA-650（Dose Escalation Period）Pustular Psoriasis | ||
| Total, all-cause mortality | TA-650（Dose Escalation Period）Psoriatic Erythroderma | ||
| Total, all-cause mortality | TA-650（Entire Evaluation Period）Plaque Psoriasis | ||
| Total, all-cause mortality | TA-650（Entire Evaluation Period）Psoriatic Arthritis |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01680159
GET https://conductscience.org/api/trials/v1/NCT01680159/results?page=2