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

Generalized Pustular Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323356
• Other study ID #: TAK-279-PsO-3005
• Secondary ID: jRCT2031230714
• Status: Recruiting
• Phase: Phase 3
• Start date: March 19, 2024
• Est. completion date: March 27, 2026

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 27, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Prior exposure to TAK-279. Other protocol defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Erythrodermic Psoriasis
• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Drug:
• TAK-279
Specified drug on specified days.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants Achieving 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 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
Secondary	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	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
Secondary	Percentage of Participants Achieving an sPGA of Clear (0) at 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
Secondary	Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at 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
Secondary	Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits	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
Secondary	Percentage of Participants Achieving 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 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
Secondary	Percentage of Participants Achieving PASI-90 at 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
Secondary	Percentage of Participants Achieving PASI-100 at 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
Secondary	Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits	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
Secondary	Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits	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
Secondary	Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a =2-Point Decrease from Baseline at 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
Secondary	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 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
Secondary	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	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
Secondary	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	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
Secondary	Change from Baseline in DLQI at 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
Secondary	Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline	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
Secondary	Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at 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
Secondary	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	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
Secondary	Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 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
Secondary	Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at 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
Secondary	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	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
Secondary	Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis	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