NCT01680159|CompletedPhase 3Results
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Sponsor study identifier
interventional
51
1 country
7
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 28, 2012
Actual (reported)September 7, 2012
Actual (reported)March 2015
Actual (reported)March 2015
Actual (reported)March 13, 2017
Actual (reported)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.
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Psoriasis Area and Severity Index (PASI) Score
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Investigational site
Chugoku, Japan
Investigational site
Chūbu, Japan
Investigational site
Hokkaido, Japan
Investigational site
Kanto, Japan
Investigational site
Kinki, Japan
Investigational site
Kyushu, Japan
Investigational site
Tōhoku, Japan
Hideshi Torii, MD
Social Insurance Central General Hospital
Kazuoki Kondo, MD
Mitsubihsi Tanabe Pharma Corporation
Hidemi Nakagawa, MD
The Jikei University School of Medicine
51 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2012
First Posted
September 7, 2012
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
LAS41008 in Moderate to Severe Chronic Plaque Psoriasis
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
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
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
Contact the study team to confirm eligibility.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
January 8, 2026
Results First Posted
March 13, 2017
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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