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Generalized Pustular PsoriasisPhase 3NCT06323356

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

A Phase 3 study testing TAK-279 in people with Generalized Pustular Psoriasis and Erythrodermic Psoriasis, run by Takeda at 20 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TAK-279
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
20 sitesJapan
Study dates
19 Mar 2024to 10 Jul 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Other forms of psoriasis.
  • History of recent infection.
  • Any prior exposure to TAK-279, or participation in any study that included a TYK2 inhibitor.
  • Other protocol defined inclusion/exclusion criteria apply.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Japan20 sites

  • St.Luke's International Hospital

    Chūō, Tokyo

  • Fukuoka University Hospital

    Fukuoka

  • Kansai Medical University Hospital

    Hirakata, Osaka

  • Saitama Medical University Hospital

    Iruma, Saitama

  • Tokai University Hospital

    Isehara, Kanagawa

  • Isesaki Municipal Hospital

    Isesaki, Gunma

  • Kimitsu Chuo Hospital

    Kisarazu, Chiba

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu, Fukuoka

  • Kobe University Hospital

    Kobe, Hyōgo

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto

  • The Jikei University Hospital

    Minato-ku, Tokyo

  • Nagoya City University Hospital

    Nagoya, Aichi-ken

  • Okayama University Hospital

    Okayama

  • Nippon Life Hospital

    Osaka

  • Osaka Metropolitan University Hospital

    Osaka

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo

  • Teikyo University Hospital

    tabashi City, Tokyo

  • Fujita Health University Hospital

    Toyoake, Aichi-ken

  • Mie University Hospital

    Tsu, Mie-ken

  • Juntendo University Urayasu Hospital

    Urayasu, Chiba

Other trials in Japan

About this study

Official title: 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.

Being tested
TAK-279
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-279Drug

    Specified drug on specified days.

Study groups in NCT06323356
Study groupRoleWhat they receive
TAK-279 for Generalized Pustular PsoriasisExperimentalParticipants with generalized pustular psoriasis will receive TAK-279 from Day 1 up to Week 52.
Receives: Drug: TAK-279
TAK-279 for Erythrodermic PsoriasisExperimentalParticipants with erythrodermic psoriasis will receive TAK-279 from Day 1 up to Week 52.
Receives: Drug: TAK-279

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater Than or Equal to (>=) 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 ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1.

    Measured: At Week 16

  2. Percentage of Participants Who Achieved >=75 Percent (%) 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 produced a numeric score that ranged 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 were reported.

    Measured: At Week 16

Secondary outcomes (23)

  1. Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at 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 ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

    Measured: At Week 52

  2. Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at Both Weeks 16 and 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 ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

    Measured: At both Weeks 16 and 52

  3. Percentage of Participants Who Achieved an sPGA of Clear (0) at Weeks 16 and 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 ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  4. Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) at Weeks 16 and 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 ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  5. Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) at Both Weeks 16 and 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 ranged from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicated more severe disease activity. 'Clear' and 'Almost clear' included all participants who scored a 0 or 1. The results will be disclosed during final posting.

    Measured: At both Weeks 16 and 52

  6. Percentage of Participants Who Achieved PASI-75 at 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 produced a numeric score that ranged 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 are reported. The results will be disclosed during final posting.

    Measured: At Week 52

  7. Percentage of Participants Who Achieved PASI-90 at Weeks 16 and 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 produced a numeric score that ranged 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 are reported. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  8. Percentage of Participants Who Achieved PASI-100 at Weeks 16 and 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 produced a numeric score that ranged 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 are reported. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  9. Percentage of Participants Who Achieved PASI-75 at Both Weeks 16 and 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 produced a numeric score that ranged 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 are reported. The results will be disclosed during final posting.

    Measured: At both Weeks 16 and 52

  10. Percentage of Participants Who Achieved PASI-90 at Both Weeks 16 and 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 produced a numeric score that ranged 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 are reported. The results will be disclosed during final posting.

    Measured: At both Weeks 16 and 52

  11. Percentage of Participants Who Achieved 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 Weeks 16 and 52

    ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions were 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 indicated worsening. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  12. Change From Baseline in ssPGA at Weeks 16 and 52

    ssPGA assesses the overall severity of active psoriasis on the participant's scalp. Scalp lesions were 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 indicated worsening. The results will be disclosed during final posting.

    Measured: Baseline, Weeks 16 and 52

  13. Percentage of Participants Who Achieved 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 52

    PGA is a 5-point scale and a score of 0 to 4 was assigned, based on the category that best described the severity of active psoriasis of the participant's hands and feet, where 0=clear and 4=severe. Higher scores indicated worsening of severity. It was evaluated for participants with the presence of active hand or foot psoriasis on Day 1. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  14. Percentage of Participants With a Baseline Dermatology Life Quality Index (DLQI) Score >=2 Who Achieved DLQI Score of 0 or 1 at Weeks 16 and 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 indicated: 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). The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  15. Change From Baseline in DLQI at Weeks 16 and 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 indicated: 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). The results will be disclosed during final posting.

    Measured: Baseline, Weeks 16 and 52

  16. Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Weeks 16 and 52 Among Participants With Nail Involvement at Baseline

    The NAPSI quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on the lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each nail was 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 fingernails evaluated and ranged from 0 to 80. Higher scores indicated more severe psoriasis. The results will be disclosed during final posting.

    Measured: Baseline, Weeks 16 and 52

  17. Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Weeks 16 and 52

    Psoriasis BSA was assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represented 1% BSA. The sum of handprints equated to the total surface area of involvement. The results will be disclosed during final posting.

    Measured: Baseline, Weeks 16 and 52

  18. Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 16 and 52

    Psoriasis BSA was assessed by means of the handprint method, where the surface of the palm and 5 digits of the participant's hand represented 1% BSA. The sum of handprints equated to the total surface area of involvement. The results will be disclosed during final posting.

    Measured: Baseline, Weeks 16 and 52

  19. Percentage of Participants With Generalized Pustular Psoriasis Who Achieved a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Weeks 16 and 52

    The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  20. Percentage of Participants With Generalized Pustular Psoriasis Who Achieved a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and 52

    The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  21. Percentage of Participants With Generalized Pustular Psoriasis Who Achieved a GPPGA of Clear (0) at Weeks 16 and 52

    The GPPGA is a common endpoint in clinical studies of GPP and is a skin-based scoring system. The GPPGA is a clinician assessment of overall GPP severity based on a modified PGA. The severity of pustules, erythema, and scaling of GPP lesions was assessed. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The GPPGA score was based on averaging the individual scores for erythema, scaling, and pustulation and ranged from 0 to 4. Higher scores indicated more severe GPP. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  22. Percentage of Participants With Generalized Pustular Psoriasis Who Achieved >=75% Improvement From Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Weeks 16 and 52

    The GPPASI is a common endpoint in clinical studies of generalized pustular psoriasis (GPP) and is a skin-based scoring system. The GPPASI is a modified composite index and an adaptation of the PASI score. The induration component was substituted with a pustule component, with an overall score ranging from 0 (least severe) to 72 (most severe). Higher scores indicated more severe GPP. The 5 grades of severity for erythema, scaling, and pustulation corresponded to 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The score for each body region was calculated as the product of the sum of severity scores and the corresponding BSA score for erythema, scaling, and pustulation, multiplied by a weighting factor for each body region. The total GPPASI score was determined as the sum of the individual scores from all body regions. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

  23. Change From Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Weeks 16 and 52 for Participants With Generalized Pustular Psoriasis

    The Japanese Dermatological Association Severity Index (JDASI) assessed systemic symptoms based on laboratory changes. With the JDASI, the skin was evaluated using 3 criteria: (1) erythema area overall, (2) erythema area with pustules, and (3) oedema area. Scoring ranged from 3 to 0 (severe, moderate, mild, none), with a maximum of 9 points. For systemic involvement, pyrexia, white blood cell count, C-reactive protein (CRP), and serum albumin were assessed, with scores ranging from 2 to 0 and a maximum of 8 points. The total JDASI score for GPP was the sum of both categories and was categorized as severe (17-11 points), moderate (10-7 points), or mild (0-6 points). Higher scores indicated more severe GPP. The results will be disclosed during final posting.

    Measured: At Weeks 16 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start19 Mar 2024
  3. Primary completion17 Oct 2025
  4. Study completion10 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06323356
Sponsor's protocol ID
TAK-279-PsO-3005
Other IDs
jRCT2031230714
Status last verified
Oct 2026
First submitted
15 Mar 2024
Last updated
4 Nov 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-279 in people with Generalized Pustular Psoriasis and Erythrodermic Psoriasis, run by Takeda at 20 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater Than or Equal to (>=) 2-Point Decrease From Baseline at Week 16 (time frame: At Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06323356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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