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Clinical Trials List

Protocol NumberTAK-279-3001

NCT Number(ClinicalTrials.gov Identfier)NCT06088043

2024-01-01 - 2026-12-31

Phase III

Recruiting7

Terminated2

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Yun-Ting Chang 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Hung Chung 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 何宜承無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

林尚宏無
鄭裕文無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSEN-FANG TSAI 無

National Taiwan University Hospital

Co-Principal Investigator

Chih-Chieh Chan 無
陳柏樺無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 邱顯鎰無

National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

黃瑞雲無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Woan-Ruoh Lee 無

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

Yi-Hsien Shih 無
Chia-Lun Chou 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Chun Yang Division of Dermatology

National Taiwan University Hospital

Co-Principal Investigator

Tak-Wah Wong

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳南霖無

MacKay Memorial Hospital

Co-Principal Investigator

蕭百芬無
王仁佑無

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 洪千惠無

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

moderate-to-severe plaque psoriasis

Objectives

main target: To evaluate the efficacy of TAK-279 30 mg taken orally once daily (QD) for 16 weeks compared with placebo in subjects with moderate to severe plaque psoriasis. Secondary goals: To further evaluate whether TAK 279 30 mg orally QD for 16 weeks is superior to placebo in subjects with moderate to severe plaque psoriasis. To evaluate whether oral TAK-279 30 mg QD is superior to apremilast after 16, 24, and 52 weeks of continued treatment with TAK279 or apremilast in subjects with moderate to severe plaque psoriasis.

Test Drug

TAK-279Apremilast

Active Ingredient

TAK-279
Apremilast

Dosage Form

Tablet
Capsule

Dosage

30mg/tablet
10mg/capsule
20mg/capsule
30mg/capsule

Endpoints

Co-primary efficacy endpoints (compared to placebo):
‧ Physician's Static Global Assessment (sPGA) 0/1 Response: Evaluated as the proportion of subjects who achieved clear (0) or nearly clear (1) sPGA at week 16 and a decrease of ?2 points since the baseline period.
‧ Psoriasis Area and Severity Index (PASI)-75 Response: Assessment as the proportion of subjects with a ?75% improvement in PASI score at Week 16 since the baseline period.

Inclution Criteria

Inclusion Criteria:
-Plaque psoriasis for at least 6 months.
-Moderate to severe disease.
-Candidate for phototherapy or systemic therapy.

Exclusion Criteria

Exclusion Criteria:
-Other forms of psoriasis.
-History of recent infection.
-Prior exposure to TAK-279 or active comparator.

The Estimated Number of Participants

Taiwan

37 participants
Global

600 participants