Clinical trial NCT06323356: A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Generalized Pustular Psoriasis
Erythrodermic Psoriasis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52
timeFrame: Baseline, Week 52
measure: 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
timeFrame: Baseline, Week 16 and Week 52
measure: Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52
timeFrame: Week 16 and Week 52
measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52
timeFrame: Week 16 and Week 52
measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits
timeFrame: Week 16 and Week 52
measure: Percentage of Participants Achieving PASI-75 at Week 52
timeFrame: Week 52
measure: Percentage of Participants Achieving PASI-90 at Week 16 and Week 52
timeFrame: Week 16 and Week 52
measure: Percentage of Participants Achieving PASI-100 at Week 16 and Week 52
timeFrame: Week 16 and Week 52
measure: Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits
timeFrame: Week 16 and Week 52
measure: Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits
timeFrame: Week 16 and Week 52
measure: 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
timeFrame: Week 16 and Week 52
measure: Change from baseline in ssPGA at Weeks 16 and 52
timeFrame: Baseline, Week 16 and Week 52
measure: 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
timeFrame: Baseline, Week 16 and Week 52
measure: 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
timeFrame: Week 16 and Week 52
measure: Change from Baseline in DLQI at Week 16 and Week 52
timeFrame: Baseline, Week 16 and Week 52
measure: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline
timeFrame: Baseline, Week 16 and Week 52
measure: Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52
timeFrame: Baseline, Week 16 and Week 52
measure: 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
timeFrame: Week 16 and Week 52
measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52
timeFrame: Week 16 and Week 52
measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52
timeFrame: Week 16 and Week 52
measure: 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
timeFrame: Weeks 16 and Week 52
measure: Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis
timeFrame: Week 16 and Week 52
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Kisarazu
country: Japan
facility: Kimitsu Chuo Hospital
state: Chiba
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Kitakyushu
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
state: Fukuoka
city: Isesaki
country: Japan
facility: Isesaki Municipal Hospital
state: Gunma
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: Mie
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Iruma
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Chuo City
country: Japan
facility: St.Luke's International Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Nippon Life Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: