Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06108544
Other study ID # TAK-279-3002
Secondary ID 2023-505842-24
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 6, 2023
Est. completion date June 10, 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
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 10, 2026
Est. primary completion date July 19, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
TAK-279
Specified drug on specified days.
Placebo
Specified drug on specified days.
Apremilast
Specified drug on specified days.

Locations

Country Name City State
Bulgaria Medical Center Asklepii OOD Dupnitsa Kjustendil
Canada Dermatrials Research Hamilton Ontario
Canada Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. - Probity - PPDS Hamilton Ontario
Canada DermEffects - Probity - PPDS London Ontario
Canada Lynderm Research Inc - Probity - PPDS Markham Ontario
Canada DermEdge Research - Probity - PPDS Mississauga Ontario
Canada The Centre for Clinical Trials Inc. - Probity - PPDS Oakville Ontario
Canada Oshawa Clinic-117 King St Oshawa Ontario
Canada SKiN Centre for Dermatology - Peterborough - Probity - PPDS Peterborough Ontario
Canada CARe Clinic Red Deer Alberta
Canada Centre For Dermatology and Cosmetic Surgery - Probity - PPDS Richmond Hill Ontario
Canada Dr. S. K. Siddha Medicine Professional Corporation - Probity - PPDS Richmond Hill Ontario
Canada Skinsense Medical Research - Probity - PPDS Saskatoon Saskatchewan
Canada Canadian Dermatology Centre - Probity - PPDS Toronto Ontario
Canada Toronto Research Centre - Probity - PPDS Toronto Ontario
Canada Alliance Clinical Trials - Probity - PPDS Waterloo Ontario
Canada Siena Medical Research Westmount Quebec
Canada XLR8 Medical Research - Probity - PPDS Windsor Ontario
Canada Wiseman Dermatology Research Inc. - Probity - PPDS Winnipeg Manitoba
Hungary Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Debrecen Hajdú-Bihar
Hungary Pécsi Tudomanyegyetem - Vasvari Pal u. Pecs
United States David Fivenson MD Dermatology PLLC Ann Arbor Michigan
United States University of Michigan Hospital - 1500 E Medical Center Dr Ann Arbor Michigan
United States Arlington Center for Dermatology Arlington Texas
United States Advanced Medical Research, PC Atlanta Georgia
United States Divine Dermatology and Aesthetics, LLC Atlanta Georgia
United States Oakland Hills Dermatology - 3400 Auburn Rd Auburn Hills Michigan
United States UT Physicians Dermatology - Bellaire Station Bellaire Texas
United States Allcutis Research LLC Beverly Massachusetts
United States Zenith Research, Inc. Beverly Hills California
United States Total Skin and Beauty Dermatology Center Birmingham Alabama
United States Beacon Clinical Research LLC Brockton Massachusetts
United States Montefiore Dermatology - BRANY - PPDS Bronx New York
United States DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location Clarksville Indiana
United States ClinOhio Research Services Columbus Ohio
United States Modern Research Associates Dallas Texas
United States Revival Research Corporation - Florida - ClinEdge - PPDS Doral Florida
United States Duke Dermatology Clinic Durham North Carolina
United States Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey
United States UNISON Clinical Trials (Shahram Jacobs md inc.) Encino California
United States Wright State Physicians Fairborn Ohio
United States Johnson Dermatology Clinic Fort Smith Arkansas
United States First OC Dermatology Research Inc. Fountain Valley California
United States Minnesota Clinical Study Center Fridley Minnesota
United States North Texas Center for Clinical Research Frisco Texas
United States Cumberland Skin Center for Clinical Research - Objective Health - PPDS Hermitage Tennessee
United States Cahaba Dermatology Skin Health Center Hoover Alabama
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States Dermatology & Advanced Aesthetics Lake Charles Louisiana
United States Vivida Dermatology - Flamingo Rd - Probity - PPDS Las Vegas Nevada
United States Long Beach Research Institute, LLC Long Beach California
United States Metropolis Dermatology Downtown LA - Probity - PPDS Los Angeles California
United States Dermatology Specialists Research - 3810 Springhurst Blvd Louisville Kentucky
United States Skin Sciences, PLLC Louisville Kentucky
United States Skin Care Physicians of Georgia Macon Georgia
United States Apex Clinical Research Center Mayfield Heights Ohio
United States Florida Academic Centers Research Miami Florida
United States San Marcus Research Clinic Inc Miami Lakes Florida
United States FXM Research Miramar Miramar Florida
United States Tennessee Clinical Research Center Nashville Tennessee
United States Mount Sinai Doctors -234 E 85th St New York New York
United States Sadick Research Group New York New York
United States Virginia Clinical Research - 6160 Kempsville Cir Norfolk Virginia
United States Northridge Clinical Trials Northridge California
United States Skin Specialists PC Omaha Nebraska
United States Austin Institute for Clinical Research, Inc. - Pflugerville - ClinEdge - PPDS Pflugerville Texas
United States Medical Dermatology Specialists Phoenix Arizona
United States University of Pittsburgh Medical Center-3601 5th Ave Pittsburgh Pennsylvania
United States Oregon Medical Research Center PC Portland Oregon
United States ALLCUTIS Research, LLC. Portsmouth New Hampshire
United States Lawrence J Green, MD LLC Rockville Maryland
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States Therapeutics Clinical Research San Diego California
United States University Clinical Trials San Diego California
United States Dermatology Institute and Skin Care Center Santa Monica California
United States NorthShore Medical Group Dermatology - Skokie Skokie Illinois
United States Derm Research Center of NY Stony Brook New York
United States Houston Center for Clinical Research, LLC Sugar Land Texas
United States Lenus Research & Medical Group Sweetwater Florida
United States Advanced Clinical Research Institute (ACRI) - Florida Tampa Florida
United States Olympian Clinical Research - 6331 Memorial Hwy Tampa Florida
United States Noble Clinical Research Tucson Arizona
United States Center For Clinical Studies, LTD. LLP - 451 N Texas Ave Webster Texas
United States The Skin Surgery Center for Clinical Research - Objective Health - PPDS Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Hungary, 

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 Comparing TAK-279 Against Placebo 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 Comparing TAK-279 Against Placebo 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 90% Improvement from Baseline in PASI (PASI-90) at Week 16 Comparing TAK-279 Against Placebo 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
Secondary Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Placebo 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
Secondary Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Placebo 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
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 Comparing TAK-279 Against Placebo 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
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 Comparing TAK-279 Against Placebo 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
Secondary 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 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
Secondary Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 Among Participants With Nail Involvement at Baseline Comparing TAK-279 Against Placebo 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
Secondary Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo 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
Secondary Percentage Change from Baseline in BSA Affected by Psoriasis at Week 16 Comparing TAK-279 Against Placebo 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
Secondary 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 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
Secondary Change from Baseline in DLQI at Week 16 Comparing TAK-279 Against Placebo 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
Secondary Change from Baseline in the Short Form-36 Health Survey (SF-36) Version 2 Scores at Week 16 Comparing TAK-279 Against Placebo 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
Secondary Change from Baseline in the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores at Week 16 Comparing TAK-279 Against Placebo 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
Secondary Change in Work Productivity and Activity Impairment-Psoriasis (WPAI-PSO) Questionnaire Scores at Week 16 Comparing TAK-279 Against Placebo 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
Secondary 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 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
Secondary Percentage of Participants Achieving PASI-75 at Week 16 Comparing TAK-279 Against Apremilast 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
Secondary Percentage of Participants Achieving PASI-90 at Week 16 Comparing TAK-279 Against Apremilast 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
Secondary 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 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
Secondary Percentage of Participants Achieving PASI-75 at Week 24 Comparing TAK-279 Against Apremilast 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
Secondary Percentage of Participants Achieving PASI-90 at Week 24 Comparing TAK-279 Against Apremilast 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
Secondary Change from Baseline in Weekly Mean PSSD Symptom Score at Week 16 Comparing TAK-279 Against Apremilast 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
Secondary 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 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
Secondary Percentage of Participants Achieving PASI-100 at Week 16 Comparing TAK-279 Against Apremilast 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
Secondary Percentage of Participants Achieving PASI-100 at Week 24 Comparing TAK-279 Against Apremilast 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
Secondary Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 Comparing TAK-279 Against Apremilast 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
Secondary Percentage of Participants with a Baseline DLQI Score =2 who Achieve DLQI Score of 0/1 at Week 16 Comparing TAK-279 Against Apremilast 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
Secondary 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 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
Secondary Change from Baseline in NAPSI Among Participants With Nail Involvement at Weeks 16 and 24 Comparing TAK-279 Against Apremilast 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
Secondary 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 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
Secondary Change from Baseline in DLQI at Weeks 16 and 24 Comparing TAK-279 Against Apremilast 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
Secondary Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast 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
Secondary Percent Change from Baseline in BSA Affected by Psoriasis at Weeks 16 and 24 Comparing TAK-279 Against Apremilast 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
Secondary Percentage of Participants Achieving an sPGA of Clear (0) at Week 24 Comparing TAK-279 Against Apremilast 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
Secondary 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 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
Secondary 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 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
Secondary Change from Baseline in ssPGA at Weeks 16 and 24 Comparing TAK-279 Against Apremilast 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
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 24 Comparing TAK-279 Against Apremilast 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
Secondary Change from Baseline in SF-36 Version 2 Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast 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
Secondary Change from Baseline in the EQ-5D-5L Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast 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
Secondary Change from Baseline in the WPAI-PSO Scores at Weeks 16 and 24 Comparing TAK-279 Against Apremilast 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
Secondary 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 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
Secondary Percentage of Participants Achieving PASI-75 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast 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
Secondary Percentage of Participants Achieving PASI-90 at Weeks 24 and 40 Comparing TAK-279 Against Apremilast 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
Secondary Time to Relapse for PASI-75 Responders at Week 40 Comparing TAK-279 Against Placebo 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
Secondary Percentage of Participants With Maintenance of PASI-75 Response at Week 60 Comparing TAK-279 Against Placebo 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
Secondary 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 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
Secondary Percentage of Participants With a Disease Relapse Comparing TAK-279 Against Placebo 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
Secondary Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) 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
Secondary Number of Participants With Clinically Significant Abnormalities in Vital Signs Up to week 69
Secondary Number of Participants With Clinically Significant Laboratory Values Up to week 69
Secondary Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings Up to week 69
See also
  Status Clinical Trial Phase
Completed NCT01194219 - Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis Phase 3
Recruiting NCT06030076 - A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
Completed NCT05600036 - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis Phase 2
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
Not yet recruiting NCT05036889 - A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes. N/A
Completed NCT04603027 - A Phase 2 Study Investigating the Effect of EDP1815 in the Treatment of Mild to Moderate Plaque Psoriasis Phase 2
Completed NCT03638258 - The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis Phase 2
Completed NCT02881346 - Efficacy and Tolerability of Enstilar® in Daily Practice
Recruiting NCT02611349 - Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis Phase 3
Completed NCT02251678 - Evaluate the Effect of Elimune Capsules Phase 1
Completed NCT01987843 - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 2
Terminated NCT01708629 - Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects Phase 3
Completed NCT01230138 - Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis Phase 2
Withdrawn NCT00747032 - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis Phase 3
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Suspended NCT01228656 - Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate Phase 2
Completed NCT00540618 - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis Phase 2