A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

November 13, 2025 updated by: Takeda

A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Adult Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Fukuoka University Hospital
      • Kyoto, Japan
        • University Hospital, Kyoto Prefectural University of Medicine
      • Okayama, Japan
        • Okayama University Hospital
      • Osaka, Japan
        • Osaka Metropolitan University Hospital
      • Osaka, Japan
        • Nippon Life Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan
        • Nagoya City University Hospital
      • Toyoake, Aichi-ken, Japan
        • Fujita Health University Hospital
    • Chiba
      • Kisarazu, Chiba, Japan
        • Kimitsu Chuo Hospital
      • Urayasu, Chiba, Japan
        • Juntendo University Urayasu Hospital
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
        • Hospital of the University of Occupational and Environmental Health, Japan
    • Gunma
      • Isesaki, Gunma, Japan
        • Isesaki Municipal Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan
        • Kobe University Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan
        • Tokai University Hospital
    • Mie-ken
      • Tsu, Mie-ken, Japan
        • Mie University Hospital
    • Osaka
      • Hirakata, Osaka, Japan
        • Kansai Medical University Hospital
    • Saitama
      • Iruma, Saitama, Japan
        • Saitama Medical University Hospital
    • Tokyo
      • Chūō, Tokyo, Japan
        • St.Luke's International Hospital
      • Itabashi-ku, Tokyo, Japan
        • Teikyo University Hospital
      • Minato-ku, Tokyo, Japan
        • The Jikei University Hospital
      • Shinjuku-ku, Tokyo, Japan
        • Tokyo Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAK-279 for Generalized Pustular Psoriasis
Participants with generalized pustular psoriasis will receive TAK-279 from Day 1 up to Week 52.
Drug: TAK-279
Specified drug on specified days.
Experimental: TAK-279 for Erythrodermic Psoriasis
Participants with erythrodermic psoriasis will receive TAK-279 from Day 1 up to Week 52.
Drug: TAK-279
Specified drug on specified days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline, 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
Time Frame: Baseline, 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52
Time Frame: Baseline, Week 52
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 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
Time Frame: Baseline, Week 16 and Week 52
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 and Week 52
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52
Time Frame: Week 16 and Week 52
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' will include all participants who score a 0.
Week 16 and Week 52
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52
Time Frame: Week 16 and Week 52
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.
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
Time Frame: Week 16 and Week 52
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.
Week 16 and Week 52
Percentage of Participants Achieving PASI-75 at Week 52
Time Frame: Week 52
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.
Week 52
Percentage of Participants Achieving PASI-90 at Week 16 and Week 52
Time Frame: Week 16 and Week 52
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 90% improvement in PASI score relative to baseline PASI score will be reported.
Week 16 and Week 52
Percentage of Participants Achieving PASI-100 at Week 16 and Week 52
Time Frame: Week 16 and Week 52
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 100% improvement in PASI score relative to baseline PASI score will be reported.
Week 16 and Week 52
Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits
Time Frame: Week 16 and Week 52
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 at both the Week 16 and Week 52 visits relative to baseline PASI score will be reported.
Week 16 and Week 52
Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits
Time Frame: Week 16 and Week 52
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 90% improvement in PASI score at both the Week 16 and Week 52 visits relative to baseline PASI score will be reported.
Week 16 and Week 52
Change from baseline in ssPGA at Weeks 16 and 52
Time Frame: Baseline, Week 16 and Week 52
ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.
Baseline, Week 16 and Week 52
Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 16 and Week 52
Time Frame: Baseline, Week 16 and Week 52
PGA is a 5-point scale and a score of 0 to 4 should be assigned, based on the category that best describes the severity of active psoriasis of the participant's hands and feet, where 0=clear and 4=severe. Higher scores indicate worsening of severity. It will be evaluated for participants with the presence of active hand or foot psoriasis on Day 1.
Baseline, Week 16 and Week 52
Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 and Week 52
Time Frame: Week 16 and Week 52
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Week 16 and Week 52
Change from Baseline in DLQI at Week 16 and Week 52
Time Frame: Baseline, Week 16 and Week 52
The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicate: 0-1 (no effect on participant's life), 2-5 (small effect on participant's life), 6-10 (moderate effect on participant's life), 11-20 (very large effect on participant's life), 21-30 (extremely large effect on participant's life).
Baseline, Week 16 and Week 52
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline
Time Frame: Baseline, Week 16 and Week 52
The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each nail will be scored for both nail matrix and nail bed psoriasis for each quadrant (ranging from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores indicate more severe psoriasis.
Baseline, Week 16 and Week 52
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52
Time Frame: Baseline, Week 16 and Week 52
Psoriasis BSA will be assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represents 1% BSA. The sum of handprints equates to the total surface area of involvement.
Baseline, Week 16 and Week 52
Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Week 16 and Week 52
Time Frame: Week 16 and Week 52
GPPGA is common endpoints in clinical studies of Generalized Pustular Psoriasis (GPP), and is skin-based scoring systems. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA, and the severity of pustules, erythema, and scaling of GPP lesions will be assessed. The five grades of severity for erythema, scaling, and pustulation correspond to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score is based on averaging the individual scores for erythema, scaling, and pustulation ranging from 0 to 4. Higher scores indicate more severe GPP.
Week 16 and Week 52
Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52
Time Frame: Week 16 and Week 52
GPPGA is common endpoints in clinical studies of Generalized Pustular Psoriasis (GPP), and is skin-based scoring systems. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA, and the severity of pustules, erythema, and scaling of GPP lesions will be assessed. The five grades of severity for erythema, scaling, and pustulation correspond to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score is based on averaging the individual scores for erythema, scaling, and pustulation ranging from 0 to 4. Higher scores indicate more severe GPP.
Week 16 and Week 52
Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52
Time Frame: Week 16 and Week 52
GPPGA is common endpoints in clinical studies of Generalized Pustular Psoriasis (GPP), and is skin-based scoring systems. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA, and the severity of pustules, erythema, and scaling of GPP lesions will be assessed. The five grades of severity for erythema, scaling, and pustulation correspond to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score is based on averaging the individual scores for erythema, scaling, and pustulation ranging from 0 to 4. Higher scores indicate more severe GPP.
Week 16 and Week 52
Percentage of Participants with Generalized Pustular Psoriasis Who Achieve ≥75% Improvement from Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Week 16 and Week 52
Time Frame: Weeks 16 and Week 52
GPPASI is common endpoints in clinical studies of GPP and is skin-based scoring systems. GPPASI is a modified composite index and an adaptation of the PASI score. The induration component has been substituted with a pustule component, with an overall score range from 0 (least severe) to 72 (most severe). Higher scores indicate more severe GPP. The five grades of severity for erythema, scaling, and pustulation correspond to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The score for each body region is calculated (the product of the sum of severity scores and its corresponding BSA score for erythema, scaling, and pustulation, multiplied by a weighting factor for each body region) and then the total GPPASI score determined (the sum of the individual scores from all body regions.
Weeks 16 and Week 52
Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis
Time Frame: Week 16 and Week 52
The Japanese Dermatological Association severity index (JDASI) assesses the systemic symptoms by laboratory changes. With the JDASI the skin is evaluated using three criteria (1) erythema area (overall), (2) erythema area with pustules and (3) oedema area. Scoring ranges from 3 to 0 (severe, moderate, mild, none) with a maximum of nine points. For systemic involvement pyrexia, white blood cell count, C reactive protein (CRP) and serum albumin with scores ranging from 2 to 0 (maximum 8 points) are assessed. The total JDASI score of GPP is the sum of both categories and categorizes as severe (17-11 points), moderate (10-7 points) or mild (0-6 points). Higher scores indicate more severe GPP.
Week 16 and Week 52
Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Absence of Disease (0) or Very Mild Disease (1) With a ≥2-Point Decrease from Baseline at Week 16 and Week 52
Time Frame: Week 16 and Week 52
ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions will be evaluated in terms of clinical signs of erythema, induration, and scaling and scored on 5-point ssPGA scale where 0=absence of disease and 4=severe disease. Higher scores indicate worsening.
Week 16 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-279-PsO-3005
  • jRCT2031230714 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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