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

NCT01680159 | Completed Phase 3 Results

• 1 other identifier: TA-650-24
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Plaque Psoriasis; Psoriatic Arthritis; Psoriatic Erythroderma; Pustular Psoriasis (Excluding a Localized)

Keywords

Infliximab; REMICADE; TA-650; psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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 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

Study Arms (1)

TA-650

EXPERIMENTAL

Drug: TA-650

Interventions

TA-650 DRUG

TA-650

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (7)

Investigational site

Chugoku, Japan

Location

Investigational site

Chūbu, Japan

Location

Investigational site

Hokkaido, Japan

Location

Investigational site

Kanto, Japan

Location

Investigational site

Kinki, Japan

Location

Investigational site

Kyushu, Japan

Location

Investigational site

Tōhoku, Japan

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Hideshi Torii, MD

  Social Insurance Central General Hospital

  STUDY DIRECTOR

• Kazuoki Kondo, MD

  Mitsubihsi Tanabe Pharma Corporation

  STUDY DIRECTOR

• Hidemi Nakagawa, MD

  The Jikei University School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 7, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 8, 2026
• Results First Posted: March 13, 2017

Record last verified: 2025-12

Locations

JP (7)