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

JRCT ID: jRCT2031230714

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Generalized Pustular Psoriasis or Erythrodermic Psoriasis
• Date of first enrollment: 19/03/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

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

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

Outcome(s)

Primary Outcome

1.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.

2.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.

Secondary Outcome

1.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

2.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

3.Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52
Time Frame: Week 16 and Week 52

4.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

5.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

6.Percentage of Participants Achieving PASI-75 at Week 52
Time Frame: Week 52

7.Percentage of Participants Achieving PASI-90 at Week 16 and Week 52
Time Frame: Week 16 and Week 52

8.Percentage of Participants Achieving PASI-100 at Week 16 and Week 52
Time Frame: Week 16 and Week 52

9.Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits
Time Frame: Week 16 and Week 52

10.Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits
Time Frame: Week 16 and Week 52

11.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
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.

12.Change from baseline in ssPGA at Weeks 16 and 52
Time Frame: Baseline, Week 16 and Week 52

13.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.

14.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).

15.Change from Baseline in DLQI at Week 16 and Week 52
Time Frame: Baseline, Week 16 and Week 52

16.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.

17.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.

18.Percentage of Participants with GPP 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.

19.Percentage of Participants with GPP Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52
Time Frame: Week 16 and Week 52

20.Percentage of Participants with GPP Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52
Time Frame: Week 16 and Week 52

21.Percentage of Participants with GPP 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.

22.Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with GPP
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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.A diagnosis of GPP or EP prior to the screening visit.
2.Candidate for phototherapy or systemic therapy.
Other protocol defined inclusion criteria apply.

Exclude criteria

1.Other forms of psoriasis.
2.History of recent infection.
3.Prior exposure to TAK-279.
Other protocol defined exclusion criteria apply.

Related Information

• Primary Sponsor: Shikamura Mitsuhiro
• Secondary ID(s): NCT06323356