A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

April 8, 2024 updated by: Takeda

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study With a Randomized Withdrawal and Retreatment Period to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis

The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis.

The study will enroll approximately 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need):

  • TAK-279
  • Apremilast
  • Placebo

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 69 weeks. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 60 weeks. There will be a safety follow-up visit 4 weeks after their last day of treatment.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 7C3
        • Not yet recruiting
        • CARe Clinic
        • Contact:
        • Principal Investigator:
          • Isaiah Day, MD
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • Wiseman Dermatology Research Inc. - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Marni Wiseman, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8L 3C3
        • Recruiting
        • Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Jose Hermenio Cavalcante Lima Filho, MD
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Not yet recruiting
        • Dermatrials Research
        • Contact:
        • Principal Investigator:
          • Ronald Vender, MD
      • London, Ontario, Canada, N6H 5L5
        • Not yet recruiting
        • DermEffects - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Wei Jing Loo, MD, MRCPCH
      • Markham, Ontario, Canada, L3P 1X3
        • Recruiting
        • Lynderm Research Inc - Probity - PPDS
        • Principal Investigator:
          • Charles Lynde, MD
        • Contact:
      • Mississauga, Ontario, Canada, L5H 1G9
        • Recruiting
        • DermEdge Research - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Mark Lomaga, MD
      • Oakville, Ontario, Canada, L6J 7W5
        • Recruiting
        • The Centre for Clinical Trials Inc. - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Sheetal Sapra, MD
      • Peterborough, Ontario, Canada, K9J 1Z2
        • Recruiting
        • SKiN Centre for Dermatology - Peterborough - Probity - PPDS
        • Principal Investigator:
          • Melinda Gooderham, MD
        • Contact:
      • Richmond Hill, Ontario, Canada, L4B 1M5
        • Not yet recruiting
        • Centre For Dermatology and Cosmetic Surgery - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Mani Raman, MD
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • Recruiting
        • Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS
        • Principal Investigator:
          • Sanjay Siddha, MD
        • Contact:
      • Toronto, Ontario, Canada, M3B 0A7
        • Recruiting
        • Canadian Dermatology Centre - Probity - PPDS
        • Principal Investigator:
          • Renita Ahluwalia, MD
        • Contact:
      • Toronto, Ontario, Canada, M3H 5Y8
        • Recruiting
        • Toronto Research Centre - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Maxwell Sauder, MD
      • Waterloo, Ontario, Canada, N2J 1C4
        • Recruiting
        • Alliance Clinical Trials - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Kim Papp, MD, PhD
      • Windsor, Ontario, Canada, N8X 3V6
        • Recruiting
        • XLR8 Medical Research - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Darryl Toth, MD
    • Quebec
      • Westmount, Quebec, Canada, H3Z 2S6
        • Recruiting
        • Siena Medical Research
        • Contact:
        • Principal Investigator:
          • Wayne Carey, MD
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Not yet recruiting
        • Skinsense Medical Research - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Kirsten Walker, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Total Skin and Beauty Dermatology Center
        • Contact:
        • Principal Investigator:
          • James Krell, MD
      • Hoover, Alabama, United States, 35244-2111
        • Recruiting
        • Cahaba Dermatology Skin Health Center
        • Contact:
        • Principal Investigator:
          • Vlada Groysman, DO, MD
    • Arizona
      • Phoenix, Arizona, United States, 85006-2722
        • Recruiting
        • Medical Dermatology Specialists
        • Contact:
        • Principal Investigator:
          • Lindsay Ackerman, MD
      • Tucson, Arizona, United States, 85704-7892
        • Not yet recruiting
        • Noble Clinical Research
        • Principal Investigator:
          • Dena Petersen, MD
        • Contact:
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916-6103
        • Recruiting
        • Johnson Dermatology Clinic
        • Principal Investigator:
          • Sandra Johnson, MD
        • Contact:
      • Hot Springs, Arkansas, United States, 71913-6475
        • Recruiting
        • Burke Pharmaceutical Research
        • Principal Investigator:
          • Dowling Stough, MD
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211-1705
        • Recruiting
        • Zenith Research, Inc.
        • Contact:
        • Principal Investigator:
          • David Stoll, MD
      • Encino, California, United States, 91436-2428
        • Recruiting
        • UNISON Clinical Trials (Shahram Jacobs md inc.)
        • Contact:
        • Principal Investigator:
          • Shahram Jacobs, MD
      • Fountain Valley, California, United States, 92708-3701
      • Long Beach, California, United States, 90805-4587
        • Recruiting
        • Long Beach Research Institute, LLC
        • Contact:
        • Principal Investigator:
          • Ashley Duzik, DO
      • Los Angeles, California, United States, 90017-5310
        • Recruiting
        • Metropolis Dermatology Downtown LA - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • James Wang, MD
      • Northridge, California, United States, 91325-4122
        • Recruiting
        • Northridge Clinical Trials
        • Principal Investigator:
          • Navid Ezra, MD
        • Contact:
      • San Diego, California, United States, 92123-1523
        • Recruiting
        • Therapeutics Clinical Research
        • Principal Investigator:
          • Neal Bhatia, MD
        • Contact:
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • University Clinical Trials
        • Principal Investigator:
          • Walter Nahm, MD, PhD
        • Contact:
      • Santa Monica, California, United States, 90404-2216
        • Recruiting
        • Dermatology Institute and Skin Care Center
        • Principal Investigator:
          • Paul Yamauchi, MD
        • Contact:
    • Florida
      • Doral, Florida, United States, 33122-1902
        • Recruiting
        • Revival Research Corporation - Florida - ClinEdge - PPDS
        • Contact:
        • Principal Investigator:
          • Ivette Espinosa-Fernandez, DO
      • Miami, Florida, United States, 33136-1003
        • Recruiting
        • Florida Academic Centers Research
        • Contact:
        • Principal Investigator:
          • Francisco Kerdel, MD
      • Miami Lakes, Florida, United States, 33014-5602
        • Recruiting
        • San Marcus Research Clinic Inc
        • Contact:
        • Principal Investigator:
          • Idalia Acosta, MD
      • Miramar, Florida, United States, 33027-4714
        • Recruiting
        • FXM Research Miramar
        • Principal Investigator:
          • Francisco Flores, MD
        • Contact:
      • Sweetwater, Florida, United States, 33172-2741
        • Recruiting
        • Lenus Research & Medical Group
        • Principal Investigator:
          • John Niven, MD
        • Contact:
      • Tampa, Florida, United States, 33607-6429
        • Recruiting
        • Advanced Clinical Research Institute (ACRI) - Florida
        • Contact:
        • Principal Investigator:
          • Francis Caban, MD
      • Tampa, Florida, United States, 33615
        • Not yet recruiting
        • Olympian Clinical Research - 6331 Memorial Hwy
        • Contact:
        • Principal Investigator:
          • Matthew Zook, MD, PhD
    • Georgia
      • Atlanta, Georgia, United States, 30315-2042
        • Not yet recruiting
        • Divine Dermatology and Aesthetics, LLC
        • Contact:
        • Principal Investigator:
          • Tunisia Cornelius
      • Atlanta, Georgia, United States, 30342-1418
        • Not yet recruiting
        • Advanced Medical Research, PC
        • Contact:
        • Principal Investigator:
          • Jamie Weisman, MD
      • Macon, Georgia, United States, 31217-3861
        • Not yet recruiting
        • Skin Care Physicians of Georgia
        • Principal Investigator:
          • David Cohen, MD
        • Contact:
    • Illinois
      • Skokie, Illinois, United States, 60077-1049
        • Recruiting
        • NorthShore Medical Group Dermatology - Skokie
        • Contact:
        • Principal Investigator:
          • Stephanie Mehlis, MD
    • Indiana
      • Clarksville, Indiana, United States, 47129-2201
        • Recruiting
        • DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
        • Contact:
        • Principal Investigator:
          • Megan Vissing, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40217-1444
        • Recruiting
        • Skin Sciences, PLLC
        • Principal Investigator:
          • Leon Kircik, MD
        • Contact:
      • Louisville, Kentucky, United States, 40241-6162
        • Recruiting
        • Dermatology Specialists Research - 3810 Springhurst Blvd
        • Contact:
        • Principal Investigator:
          • Cindy Owen, MD
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605-1213
        • Not yet recruiting
        • Dermatology & Advanced Aesthetics
        • Contact:
        • Principal Investigator:
          • Shondra Smith, MD
    • Maryland
      • Rockville, Maryland, United States, 20850-6363
        • Recruiting
        • Lawrence J Green, MD LLC
        • Contact:
        • Principal Investigator:
          • Lawrence Green, MD
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Not yet recruiting
        • Allcutis Research LLC
        • Principal Investigator:
          • David Greenstein, MD
        • Contact:
      • Brockton, Massachusetts, United States, 02301
        • Recruiting
        • Beacon Clinical Research LLC
        • Contact:
        • Principal Investigator:
          • Victoria Kuohung, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48103-9746
        • Not yet recruiting
        • David Fivenson MD Dermatology PLLC
        • Contact:
        • Principal Investigator:
          • David Fivenson, MD
      • Ann Arbor, Michigan, United States, 48109-5360
        • Recruiting
        • University of Michigan Hospital - 1500 E Medical Center Dr
        • Contact:
        • Principal Investigator:
          • Michael Goldfarb, MD
      • Auburn Hills, Michigan, United States, 48326-3396
        • Recruiting
        • Oakland Hills Dermatology - 3400 Auburn Rd
        • Contact:
        • Principal Investigator:
          • Christofer Buatti, DO
    • Minnesota
      • Fridley, Minnesota, United States, 55432-3134
        • Recruiting
        • Minnesota Clinical Study Center
        • Principal Investigator:
          • Steven Kempers, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Skin Specialists PC
        • Principal Investigator:
          • Joel Schlessinger, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89119-5190
        • Not yet recruiting
        • Vivida Dermatology - Flamingo Rd - Probity - PPDS
        • Contact:
        • Principal Investigator:
          • Victoria Farley, MD
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Not yet recruiting
        • ALLCUTIS Research, LLC.
        • Contact:
        • Principal Investigator:
          • Abel Jarell, MD
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Recruiting
        • Psoriasis Treatment Center of Central New Jersey
        • Principal Investigator:
          • Jerry Bagel, MD
        • Contact:
    • New York
      • Bronx, New York, United States, 10467-1402
        • Not yet recruiting
        • Montefiore Dermatology - BRANY - PPDS
        • Principal Investigator:
          • Holly Kanavy, DO
        • Contact:
      • New York, New York, United States, 10075-0385
        • Recruiting
        • Sadick Research Group
        • Contact:
        • Principal Investigator:
          • Neil Sadick, MD
      • New York, New York, United States, 10029-6504
        • Recruiting
        • Mount Sinai Doctors -234 E 85th St
        • Contact:
        • Principal Investigator:
          • Saakshi Khattri, MD
      • Stony Brook, New York, United States, 11790
        • Recruiting
        • Derm Research Center of NY
        • Contact:
        • Principal Investigator:
          • Elyse Rafal, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103-7109
        • Recruiting
        • The Skin Surgery Center for Clinical Research - Objective Health - PPDS
        • Contact:
        • Principal Investigator:
          • Kevin Stein, MD
    • Ohio
      • Columbus, Ohio, United States, 43213-4445
        • Not yet recruiting
        • ClinOhio Research Services
        • Contact:
        • Principal Investigator:
          • Benjamin Bogucki, MD
      • Fairborn, Ohio, United States, 45324
        • Recruiting
        • Wright State Physicians
        • Principal Investigator:
          • Craig Rohan, MD
        • Contact:
      • Mayfield Heights, Ohio, United States, 44124-4005
        • Recruiting
        • Apex Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Jorge Garcia-Zuazaga, MD
    • Oregon
      • Portland, Oregon, United States, 97239-4501
        • Recruiting
        • Oregon Medical Research Center PC
        • Contact:
        • Principal Investigator:
          • Benjamin Ehst, MD, PhD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3403
        • Not yet recruiting
        • University of Pittsburgh Medical Center-3601 5th Ave
        • Contact:
        • Principal Investigator:
          • Laura Ferris, MD, PhD
    • Tennessee
      • Hermitage, Tennessee, United States, 37076-3497
        • Recruiting
        • Cumberland Skin Center for Clinical Research - Objective Health - PPDS
        • Contact:
        • Principal Investigator:
          • Judy Hu
      • Nashville, Tennessee, United States, 37215-2888
        • Recruiting
        • Tennessee Clinical Research Center
        • Principal Investigator:
          • Michael Gold, MD
        • Contact:
    • Texas
      • Arlington, Texas, United States, 76011-3800
        • Recruiting
        • Arlington Center for Dermatology
        • Contact:
        • Principal Investigator:
          • Angela Moore, MD
      • Bellaire, Texas, United States, 77401-3535
        • Recruiting
        • UT Physicians Dermatology - Bellaire Station
        • Contact:
        • Principal Investigator:
          • Adelaide Hebert, MD
      • Dallas, Texas, United States, 75231-6077
        • Recruiting
        • Modern Research Associates
        • Contact:
        • Principal Investigator:
          • Jennifer Cather, MD
      • Frisco, Texas, United States, 75034
        • Recruiting
        • North Texas Center for Clinical Research
        • Principal Investigator:
          • Timothy Rodgers, MD
        • Contact:
      • Pflugerville, Texas, United States, 78660-6148
        • Recruiting
        • Austin Institute for Clinical Research, Inc. - Pflugerville - ClinEdge - PPDS
        • Principal Investigator:
          • Edward Lain, MD
        • Contact:
      • San Antonio, Texas, United States, 78218-3128
        • Recruiting
        • Texas Dermatology and Laser Specialists
        • Contact:
        • Principal Investigator:
          • John Browning, MBA, MD
      • San Antonio, Texas, United States, 78229-3409
        • Recruiting
        • Dermatology Clinical Research Center of San Antonio
        • Principal Investigator:
          • Steven Davis, MD
        • Contact:
      • Sugar Land, Texas, United States, 77479-1001
        • Recruiting
        • Houston Center for Clinical Research, LLC
        • Contact:
        • Principal Investigator:
          • Aparna Tamirisa, MD
      • Webster, Texas, United States, 77598-4927
        • Recruiting
        • Center For Clinical Studies, LTD. LLP - 451 N Texas Ave
        • Principal Investigator:
          • Patricia Lee, MD
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Virginia Clinical Research - 6160 Kempsville Cir
        • Contact:
        • Principal Investigator:
          • David Pariser, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Plaque psoriasis for at least 6 months.
  2. Moderate to severe disease.
  3. Candidate for phototherapy or systemic therapy.

Exclusion Criteria:

  1. Other forms of psoriasis.
  2. History of recent infection.
  3. Prior exposure to TAK-279 or active comparator.

Other protocol defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Specified drug on specified days.
Active Comparator: Apremilast
Drug: Apremilast
Specified drug on specified days.
Experimental: TAK-279
Drug: TAK-279
Specified drug on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Comparing TAK-279 Against Placebo
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.
Baseline, Week 16
Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Comparing TAK-279 Against Placebo
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.
Baseline, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo
Time Frame: 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. Higher scores indicate worsening. 'Clear' will include all participants who score a 0.
Week 16
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo
Time Frame: 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 100% improvement in PASI score relative to baseline PASI score will be reported.
Week 16
Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Week 16
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
Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Week 16
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score will be expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Week 16
Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: 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.
Week 16
Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: 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 90% improvement in PASI score relative to baseline PASI score will be reported.
Week 16
Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast
Time Frame: Week 24
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 24
Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast
Time Frame: Week 24
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 24
Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: 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 100% improvement in PASI score relative to baseline PASI score will be reported.
Week 16
Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast
Time Frame: Week 24
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 24
Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: 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' will include all participants who score a 0.
Week 16
Percentage of Participants with a Baseline DLQI Score ≥2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: Week 16
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).
Week 16
Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
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, Weeks 16 and 24
Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
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, Weeks 16 and 24
Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
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, Weeks 16 and 24
Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast
Time Frame: Week 24
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 24
Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
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, Weeks 16 and 24
Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
The SF-36 is a self-administered, validated questionnaire designed to measure generic health-related QoL. This 36-item questionnaire measures 8 domains, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Two summary scores, including the PCS and MCS, will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL.
Baseline, Weeks 16 and 24
Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). The scores in the 5 dimensions will be summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health; 0=a health state equivalent to death, and 1=perfect health.
Baseline, Weeks 16 and 24
Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score will be expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
Baseline, Weeks 16 and 24
Percentage of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90) at Week 16 Comparing TAK-279 Against Placebo
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 90% improvement in PASI score relative to baseline PASI score will be reported.
Baseline, Week 16
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 Comparing TAK-279 Against Placebo
Time Frame: Baseline, Week 16
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
Percentage of Participants With a Baseline Psoriasis Symptoms and Signs Diary (PSSD) ≥1 who Achieve Weekly Mean Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Week 16
The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.
Week 16
Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants With Nail Involvement at Baseline Comparing TAK-279 Against Placebo
Time Frame: Baseline, Week 16
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
Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Week 16
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.
Week 16
Percentage Change from Baseline in BSA Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Week 16
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.
Week 16
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease From Baseline at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Baseline, Week 16
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
Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Baseline, Week 16
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). It will be evaluated for participants with a baseline DLQI score ≥2.
Baseline, Week 16
Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Baseline, Week 16
The SF-36 is a self-administered, validated questionnaire designed to measure generic health-related QoL. This 36-item questionnaire measures 8 domains, including physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health, physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Two summary scores, including the physical component summary (PCS) and mental component summary (MCS), will be calculated ranging from 0 (worst) to 100 (best). Higher scores indicate better QoL.
Baseline, Week 16
Change from Baseline in the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo
Time Frame: Baseline, Week 16
EQ-5D-5L includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and 5 response levels for each domain (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). The scores in the 5 dimensions will be summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health; 0=a health state equivalent to death, and 1=perfect health.
Baseline, Week 16
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: Baseline to 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. Higher scores indicate worsening. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Baseline to Week 16
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline to Week 24
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 to Week 24
Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: Baseline to Week 16
The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.
Baseline to Week 16
Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: Baseline to Week 16
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 to Week 16
Percentage of Participants With a Baseline PSSD ≥1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 16 Comparing TAK-279 Against Apremilast
Time Frame: Week 16
The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.
Week 16
Change from Baseline in NAPSI Among Participants With Nail Involvement at Weeks 16 and 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
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, Weeks 16 and 24
Percentage of Participants Achieving an ssPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline to Week 24
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 to Week 24
Percentage of Participants With a Baseline DLQI Score ≥2 who Achieve a DLQI Score of 0/1 at Week 24 Comparing TAK-279 Against Apremilast
Time Frame: Week 24
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).
Week 24
Percentage of Participants With a Baseline PSSD ≥1 who Achieve a Weekly Mean PSSD Symptom Score of 0 at Week 24 Comparing TAK-279 Against Apremilast
Time Frame: Week 24
The PSSD is an 11-item validated questionnaire that assesses symptoms (itch, pain, stinging, burning, and skin tightness) and participant-observable signs (skin dryness, cracking, scaling, shedding/flaking, redness, and bleeding) of moderate-to-severe plaque psoriasis. These symptoms and signs will be evaluated by asking participants to assign a numerical score representing of worst intensity over the last 24-hour on a scale from 0 to 10, with 0 indicating absence of symptoms or signs and 10 indicating worst imaginable symptoms or signs. The PSSD is a composite score calculated based on the scores for each question that can range between 0 and 100. A higher score indicates more severe disease.
Week 24
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 24 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 16 and 24
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, Weeks 16 and 24
Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
Time Frame: Baseline, Weeks 24 and 40
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, Weeks 24 and 40
Percentage of Participants Achieving PASI-75 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
Time Frame: Weeks 24 and 40
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.
Weeks 24 and 40
Percentage of Participants Achieving PASI-90 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast
Time Frame: Weeks 24 and 40
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.
Weeks 24 and 40
Time to Relapse for PASI-75 Responders at Week 40 Comparing TAK-279 Against Placebo
Time Frame: Up to Week 60
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.
Up to Week 60
Percentage of Participants With Maintenance of PASI-75 Response at Week 60 Comparing TAK-279 Against Placebo
Time Frame: Week 60
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 60
Percentage of Participants with Maintenance of sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 60 Comparing TAK-279 Against Placebo
Time Frame: Baseline to Week 60
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 to Week 60
Percentage of Participants With a Disease Relapse Comparing TAK-279 Against Placebo
Time Frame: Week 40
Relapse is defined as a percent change from baseline in PASI score that is at least 50% worse than that observed at Week 40. 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. Higher scores indicate worsening.
Week 40
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)
Time Frame: Up to week 69
TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI (serious or nonserious) is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
Up to week 69
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time Frame: Up to week 69
Up to week 69
Number of Participants With Clinically Significant Laboratory Values
Time Frame: Up to week 69
Up to week 69
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time Frame: Up to week 69
Up to week 69

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

July 19, 2025

Study Completion (Estimated)

June 10, 2026

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-279-3002
  • 2023-505842-24 (Registry Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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