NCT06323356

Brief Summary

The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
3mo left

Started Mar 2024

Geographic Reach
1 country

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Mar 2024Jul 2026

First Submitted

Initial submission to the registry

March 15, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2026

Expected
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

March 15, 2024

Last Update Submit

November 13, 2025

Conditions

Generalized Pustular PsoriasisErythrodermic Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16

    The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.

    Baseline, Week 16

  • Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16

    PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.

    Baseline, Week 16

Secondary Outcomes (22)

  • Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52

    Baseline, Week 52

  • Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Both Week 16 and Week 52 Visits

    Baseline, Week 16 and Week 52

  • Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52

    Week 16 and Week 52

  • Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52

    Week 16 and Week 52

  • Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits

    Week 16 and Week 52

  • +17 more secondary outcomes

Study Arms (2)

TAK-279 for Generalized Pustular Psoriasis

EXPERIMENTAL

Participants with generalized pustular psoriasis will receive TAK-279 from Day 1 up to Week 52.

Drug: TAK-279

TAK-279 for Erythrodermic Psoriasis

EXPERIMENTAL

Participants with erythrodermic psoriasis will receive TAK-279 from Day 1 up to Week 52.

Drug: TAK-279

Interventions

TAK-279DRUG

Specified drug on specified days.

TAK-279 for Erythrodermic PsoriasisTAK-279 for Generalized Pustular Psoriasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of GPP or EP prior to the screening visit.
  • Candidate for phototherapy or systemic therapy.

You may not qualify if:

  • Other forms of psoriasis.
  • History of recent infection.
  • Any prior exposure to TAK-279, or participation in any study that included a TYK2 inhibitor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Location

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Location

Kimitsu Chuo Hospital

Kisarazu, Chiba, Japan

Location

Juntendo University Urayasu Hospital

Urayasu, Chiba, Japan

Location

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, Japan

Location

Isesaki Municipal Hospital

Isesaki, Gunma, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, Japan

Location

Mie University Hospital

Tsu, Mie-ken, Japan

Location

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Location

Saitama Medical University Hospital

Iruma, Saitama, Japan

Location

St.Luke's International Hospital

Chūō, Tokyo, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Location

The Jikei University Hospital

Minato-ku, Tokyo, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Fukuoka University Hospital

Fukuoka, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Nippon Life Hospital

Osaka, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Japan

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 21, 2024

Study Start

March 19, 2024

Primary Completion

October 15, 2025

Study Completion (Estimated)

July 22, 2026

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

JP(20)