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NCT06323356

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

StatusCompleted
PhasePhase 3
SponsorTakeda
Primary completion
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Record History

All 18 versions: 12 with changes below, 6 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Nov 4, 2026 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 5 words
    • Secondary endpoints: 22 to 23
    • Site details revised at 2 of 20 sites
  2. Trial completed
    • Primary completion date: Oct 15, 2025 to Oct 17, 2025
    • Study completion date changed from estimate of Jul 22, 2026 to Jul 10, 2026
    v17
  3. Trial status: Recruiting to Active, Not Recruitingv15 Show 4 more changesShow less
    • Enrollment target: estimated 20 to confirmed 18
    • Primary completion date: Jun 30, 2025 to Oct 15, 2025
    • Study completion date: Mar 27, 2026 to Jul 22, 2026
    • Site details revised at 20 of 20 sites
  4. Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (22)
    v11
  5. Site details revised at 1 of 20 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 3 of 20 sitesv7
  2. Site details revised at 5 of 20 sitesv6
  3. Site details revised at 7 of 20 sitesv5
  4. Site details revised at 2 of 20 sitesv4
  5. Study sites: 2 to 20v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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
Timeframe: At Week 16
Percentage of Participants Who Achieved >=75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16
Timeframe: At Week 16

Secondary (23)

Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) With a >=2-Point Decrease From Baseline at Week 52
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
Percentage of Participants Who Achieved an sPGA of Clear (0) at Weeks 16 and 52
Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) at Weeks 16 and 52
Percentage of Participants Who Achieved an sPGA of Clear (0) or Almost Clear (1) at Both Weeks 16 and 52
Show 18 moreShow less
Percentage of Participants Who Achieved PASI-75 at Week 52
Percentage of Participants Who Achieved PASI-90 at Weeks 16 and 52
Percentage of Participants Who Achieved PASI-100 at Weeks 16 and 52
Percentage of Participants Who Achieved PASI-75 at Both Weeks 16 and 52
Percentage of Participants Who Achieved PASI-90 at Both Weeks 16 and 52
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
Change From Baseline in ssPGA at Weeks 16 and 52
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
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
Change From Baseline in DLQI at Weeks 16 and 52
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Weeks 16 and 52 Among Participants With Nail Involvement at Baseline
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Weeks 16 and 52
Percent Change From Baseline in BSA Affected by Psoriasis at Weeks 16 and 52
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
Percentage of Participants With Generalized Pustular Psoriasis Who Achieved a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and 52
Percentage of Participants With Generalized Pustular Psoriasis Who Achieved a GPPGA of Clear (0) at Weeks 16 and 52
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
Change From Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Weeks 16 and 52 for Participants With Generalized Pustular Psoriasis

Arms and interventions

TAK-279 for Generalized Pustular PsoriasisExperimental

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

TAK-279 for Erythrodermic PsoriasisExperimental

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

Drugs: TAK-279

Sites

20 sites in 1 country