Back to resultsEfficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE) (TRIBUTE)
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tildrakizumab 100 mg Solution for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Tildrakizumab, Moderate-to-Severe Chronic Plaque Psoriasis, Quality of Life (QoL)
Eligibility Criteria
Inclusion Criteria:
- Provide signed written and dated informed consent given before any study related activity is performed
- Participants with a diagnosis of moderate to severe plaque psoriasis
- Participants eligible for systemic biologic treatment as assessed by the investigator or having had a primary/secondary failure to treatment with one or more anti-Tumor Necrosis Factor (TNF) biologic agents for psoriasis
Exclusion Criteria:
- Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study
- Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®
- Women currently pregnant, or intend to become pregnant or breastfeeding. Unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary)
- Other forms of psoriasis than chronic plaque-type
- Current severe and/or uncontrolled psoriatic arthritis (PsA), or participants with PsA that is currently receiving systemic treatment
- Drug-induced psoriasis at the Screening Visit
- Concurrent malignancy, current relevant autoimmune diseases other than psoriasis
- Participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the screening visit
- Active infection disease or history of recurrent infection
- Active or latent tuberculosis (TB) at Screening visit
- Positive test for human immunodeficiency virus or any other immunosuppressive disease
- Participants with exposure to psoriasis systemic investigational drugs in the previous year
- Live vaccination within 4 weeks prior to the Baseline Visit
- Participants who intend to use any concomitant medication with immunomodulating or systemic corticosteroids
Sites / Locations
- Investigator Site 9
- Investigator Site 11
- Investigator Site 7
- Investigator Site 15
- Investigator Site 14
- Investigator Site 4
- Investigator Site 6
- Investigator Site 12
- Investigator Site 2
- Investigator Site 13
- Investigator Site 10
- Investigator Site 16
- Investigator Site 18
- Investigator Site 19
- Investigator Site 17
- Investigator Site 3
- Investigator Site 5
- Investigator Site 1
- Investigator Site 8
- Investigator Site 14
- Investigator Site 18
- Investigator Site 12
- Investigator Site 20
- Investigator Site 2
- Investigator Site 3
- Investigator Site 4
- Investigator Site 16
- Investigator Site 22
- Investigator Site 1
- Investigator Site 19
- Investigator Site 21
- Investigator Site 6
- Investigator Site 7
- Investigator Site 8
- Investigator Site 9
- Investigator Site 13
- Investigator Site 11
- Investigator Site 17
- Investigator Site 15
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tildrakizumab
Arm Description
Participants will receive subcutaneous (SC) injection of tildrakizumab 100 milligrams (mg).
Outcomes
Primary Outcome Measures
Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Dermatology Life Quality Index (DLQI) Score at Week 24
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score at Week 24
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Change from baseline will be calculated by subtracting post-dose value baseline value.
Secondary Outcome Measures
Percentage of Participants Achieving Absolute Dermatology Life Quality Index (DLQI) Scores Between 0-1 at Week 24
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Percentage of Participants Achieving Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score Between 0-1 at Week 24.
DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. The DLQI-R scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses.
Absolute Dermatology Life Quality Index (DLQI) Score
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score
DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. The DLQI-R scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses.
Change from Baseline in the Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score
DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. The DLQI-R scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses. Change from baseline will be calculated by subtracting post-dose value baseline value.
Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Score of 5, 3, and 1
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Absolute Psoriasis Area and Severity Index (PASI) Score
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Physician Global Assessment (PGA) Score
The PGA used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.
Change from Baseline in the Absolute Physician Global Assessment (PGA) Score
The PGA used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score. Change from baseline will be calculated by subtracting post-dose value baseline value.
Percentage of Participants Achieving Physician Global Assessment (PGA) Score of 0 or 1 with At Least a 2-Grade Reduction from Baseline
The PGA used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.
Absolute Body Surface Area (BSA) Score
BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%).
Change from Baseline in the Absolute Body Surface Area (BSA) Score
BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The Investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%). Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Pruritus-Numerical Rating Scale (NRS) Score
Pruritus is assessed by ticking the number on a 11 points scale, going from 0 - no pruritus, to 10 - worst imaginable pruritus. Higher scores depict worst pain.
Change from Baseline in the Absolute Pruritus-Numerical Rating Scale (NRS) Score
Pruritus is assessed by ticking the number on a 11 points scale, going from 0 - no pruritus, to 10 - worst imaginable pruritus. Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Pain-Numerical Rating Scale (NRS) Score
The pain-NRS is an 11-point ordinal scale assessing pain, from 0 (no pain) to 10 (worst imaginable pain). Higher scores depict worst pain.
Change from Baseline in the Absolute Pain-Numerical Rating Scale (NRS) Score
The pain-NRS is an 11-point ordinal scale assessing pain, from 0 (no pain) to 10 (worst imaginable pain). Higher scores depict worst pain. Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Scaling-Numerical Rating Scale (NRS) Score
The scaling-NRS is an 11-point ordinal scale assessing scaling, from 0 (no pain) to 10 (worst imaginable pain). Higher scores depict worst pain.
Change from Baseline in the Absolute Scaling-Numerical Rating Scale (NRS) Score
The scaling-NRS is an 11-point ordinal scale assessing scaling, from 0 (no pain) to 10 (worst imaginable pain). Higher scores depict worst pain. Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Skindex-16 Questionnaire Score at Week 24
Skindex is the best dermatological instruments to measure dermatology-specific health-related quality of life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1- 4), emotions (5 -11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100.
Change from Baseline in the Absolute Skindex-16 Questionnaire Score at Week 24
Skindex is the best dermatological instruments to measure dermatology-specific health-related quality of life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100. Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Medical Outcome Study (MOS) Sleep Score at Baseline and Week 24
The MOS-Sleep includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS sleep reflects more of the attribute indicated by the subscale name.
Change from Baseline in the Absolute Medical Outcome Study (MOS) Sleep Score at Baseline and Week 24
The MOS-Sleep includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS sleep reflects more of the attribute indicated by the subscale name. Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Work Productivity and Activity Impairment (WPAI) Score at Week 24
The WPAI questionnaire is an instrument to measure impairments in both paid work and unpaid work. The WPAI questionnaire consists of 6 questions that are used to assess: 1-employment status (yes/no), 2- work time missed due to Psoriasis (hours), 3-work time missed due to other reasons (hours), 4-actual work time (hours), 5-the impact of Psoriasis on work productivity while at work (0:10 point scale), and 6-the impact of Psoriasis on activities outside of work (0:10 point scale) for the 7 days prior to questionnaire completion. Four scores are derived from the questions: percent absenteeism (work time missed), percent presenteeism (impairment at work), percent work productivity loss (overall work impairment due to absenteeism and presenteeism), and percent activity impairment (activities performed outside of work). Higher scores indicate a higher level of impairment.
Change from Baseline in the Absolute Work Productivity and Activity Impairment (WPAI) Score at Week 24
The WPAI questionnaire is an instrument to measure impairments in both paid work and unpaid work. The WPAI questionnaire consists of 6 questions that are used to assess: 1-employment status (yes/no), 2- work time missed due to Psoriasis (hours), 3-work time missed due to other reasons (hours), 4-actual work time (hours), 5-the impact of Psoriasis on work productivity while at work (0:10 point scale), and 6-the impact of Psoriasis on activities outside of work (0:10 point scale) for the 7 days prior to questionnaire completion. Four scores are derived from the questions: percent absenteeism (work time missed), percent presenteeism (impairment at work), percent work productivity loss (overall work impairment due to absenteeism and presenteeism), and percent activity impairment (activities performed outside of work). Higher scores indicate a higher level of impairment. Change from baseline will be calculated by subtracting post-dose value baseline value.
Absolute Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 24
The TSQM is a 14-item self-reported generic instrument designed to measure participant satisfaction with medication treatment. The 4 scales of the TSQM include the Effectiveness subscale, the Side Effects subscale (items 4-8), the Convenience subscale (items 9-11), and the Global Satisfaction subscale (items 12-14). The last subscale is regarded both in concept and in research as a superordinate, second-order global factor encompassing the other 3 more specific domains of medication experiences. Responses are obtained on a 5-point or a 7-point Likert scale (range, 1 extremely dissatisfied'' to 7 extremely satisfied'') for all but 1 item that has a yes-no response option. The subscale scores are transformed into scores ranging from 0 to 100, with higher scores representing higher satisfaction on that domain. Regarding the Side Effects subscale, when the participant answers no'' to experiencing side effects (item 4), this subscale is scored as 100.
Percentage of Participants Achieving a Score Greater Than or Equal to (>=) 1 in the Absolute Patient Benefit Index (PBI) Score at Week 24.
This is a questionnaire of 23 items on participant-relevant therapy needs and benefits. The first part of the instrument, the Participant Needs Questionnaire (PNQ), is filled in by the participant before therapy. A five- step Likert scale (0 = not important at all to 4 = very important) records the individual relevance of the different items to the participant. The second part, the Participant Benefit Questionnaire (PBQ), is filled in by the participants during or after therapy. It comprises the same items as the PNQ, but in contrast, the participants evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0 = treatment did not help at all to 4 = treatment helped a lot). In addition, the Likert scale contains the option does not apply to me in the PNQ and the option did not apply to me in the PBQ. This questionnaire score ranges from 0 = no benefit to 4 = maximal benefit. A PBI value of >=1 is considered as relevant benefit.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
An Adverse Event (AE) will be considered as TEAE if it was not present prior to the first dose of the study drug or was present prior to the first dose of study drug, but increased in severity during the treatment period.
Absolute High-sensitivity C-Reactive Protein (hs-CRP) at Week 24
The hs-CRP will be assessed as safety serum biochemistry parameters.
Change from Baseline in the Absolute High-sensitivity C-Reactive Protein (hs-CRP) at Week 24
The hs-CRP will be assessed as safety serum biochemistry parameters. Change from baseline will be calculated by subtracting post-dose value baseline value.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04229836
Brief Title
Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)
Acronym
TRIBUTE
Official Title
An International, Multicentre, Open- Label, Interventional Phase IV Clinical Study to Investigate the Efficacy and Safety of Tildrakizumab 100 mg in Patients With Moderate- Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main aim of the study is to evaluate the efficacy, safety and impact on the health-related quality of life (HRQoL) in participants with moderate-to-severe chronic plaque psoriasis who are treated with tildrakizumab 100 milligrams (mg).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Tildrakizumab, Moderate-to-Severe Chronic Plaque Psoriasis, Quality of Life (QoL)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tildrakizumab
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous (SC) injection of tildrakizumab 100 milligrams (mg).
Intervention Type
Drug
Intervention Name(s)
Tildrakizumab 100 mg Solution for Injection
Intervention Description
Participants will be treated with tildrakizumab 100 mg.
Primary Outcome Measure Information:
Title
Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Time Frame
Week 24
Title
Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score at Week 24
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1) and Week 24
Title
Absolute Dermatology Life Quality Index (DLQI) Score at Week 24
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Time Frame
Week 24
Title
Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score at Week 24
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1) and Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Absolute Dermatology Life Quality Index (DLQI) Scores Between 0-1 at Week 24
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Time Frame
Week 24
Title
Percentage of Participants Achieving Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score Between 0-1 at Week 24.
Description
DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. The DLQI-R scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses.
Time Frame
Week 24
Title
Absolute Dermatology Life Quality Index (DLQI) Score
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Change from Baseline in the Absolute Dermatology Life Quality Index (DLQI) Score
Description
DLQI is a questionnaire which is to evaluate the impact on participant's quality of life due to psoriasis. It is composed of ten items related to symptoms, feelings, daily activities, leisure, working or studying activities, personal relationships and opinions about dermatological treatment. Each item is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score
Description
DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. The DLQI-R scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Change from Baseline in the Absolute Dermatology Quality of Life Index Relevant (DLQI-R) Score
Description
DLQI-R is a scoring modification for the DLQI to better evaluate not relevant responses on the DLQI that could lead to underestimation of the impact on quality of life. The DLQI-R scoring modification involves multiplying the original DLQI score by a conversion factor that increases with the number of not relevant responses. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Percentage of Participants Achieving Absolute Psoriasis Area and Severity Index (PASI) Score of 5, 3, and 1
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Absolute Psoriasis Area and Severity Index (PASI) Score
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease).
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Change from Baseline in the Absolute Psoriasis Area and Severity Index (PASI) Score
Description
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and scaling on a scale range from 0 (no symptoms) to 4 (very marked), together with the percentage (%) of the area affected, rated on a scale from 0 (0%) to 6 (90-100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 (no psoriasis) to 72 (the most severe disease). Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Absolute Physician Global Assessment (PGA) Score
Description
The PGA used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Change from Baseline in the Absolute Physician Global Assessment (PGA) Score
Description
The PGA used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Percentage of Participants Achieving Physician Global Assessment (PGA) Score of 0 or 1 with At Least a 2-Grade Reduction from Baseline
Description
The PGA used to assess the overall severity of the psoriasis lesions at the time of evaluation. Overall lesions will be graded for erythema, induration, and scale based on 6-point scale ranging from 0 (clear) to 5 (severe). The sum of 3 scales will be divided by 3 to obtain final PGA score.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Absolute Body Surface Area (BSA) Score
Description
BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%).
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Change from Baseline in the Absolute Body Surface Area (BSA) Score
Description
BSA is a numerical score used to measure the total area of the body affected by psoriasis. The palm method will be applied: the participant's palm, including the five digits is used as a reference (representing approximately 1% of the total body surface area) and is used to repeatedly cover the lesions on the body. The Investigator totals the number of palms required and then estimates the percentage (%) in each of the four body regions: head (including scalp) and neck (10%); upper extremities (20%); trunk (30%); and lower extremities (40%). Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Absolute Pruritus-Numerical Rating Scale (NRS) Score
Description
Pruritus is assessed by ticking the number on a 11 points scale, going from 0 - no pruritus, to 10 - worst imaginable pruritus. Higher scores depict worst pain.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Change from Baseline in the Absolute Pruritus-Numerical Rating Scale (NRS) Score
Description
Pruritus is assessed by ticking the number on a 11 points scale, going from 0 - no pruritus, to 10 - worst imaginable pruritus. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Absolute Pain-Numerical Rating Scale (NRS) Score
Description
The pain-NRS is an 11-point ordinal scale assessing pain, from 0 (no pain) to 10 (worst imaginable pain). Higher scores depict worst pain.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Change from Baseline in the Absolute Pain-Numerical Rating Scale (NRS) Score
Description
The pain-NRS is an 11-point ordinal scale assessing pain, from 0 (no pain) to 10 (worst imaginable pain). Higher scores depict worst pain. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Absolute Scaling-Numerical Rating Scale (NRS) Score
Description
The scaling-NRS is an 11-point ordinal scale assessing scaling, from 0 (no pain) to 10 (worst imaginable pain). Higher scores depict worst pain.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Change from Baseline in the Absolute Scaling-Numerical Rating Scale (NRS) Score
Description
The scaling-NRS is an 11-point ordinal scale assessing scaling, from 0 (no pain) to 10 (worst imaginable pain). Higher scores depict worst pain. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1), Week 4, 16, 24
Title
Absolute Skindex-16 Questionnaire Score at Week 24
Description
Skindex is the best dermatological instruments to measure dermatology-specific health-related quality of life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1- 4), emotions (5 -11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100.
Time Frame
Week 24
Title
Change from Baseline in the Absolute Skindex-16 Questionnaire Score at Week 24
Description
Skindex is the best dermatological instruments to measure dermatology-specific health-related quality of life (HRQoL). The 16-item Skindex questionnaire is divided into three domains: questions related to the participant's symptoms (1-4), emotions (5-11), and functioning (12-16). Each question asks the participant to quantify how much a specific aspect of their skin condition bothered them in the week prior to administration of the Skindex-16. The questions are answered on a scale from 0 (never bothered) to 6 (always bothered) with a total possible score ranging from 0 (best HRQoL) to 96 (worst HRQoL). Each item is then transformed to a linear scale from 0 to 100. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1) and Week 24
Title
Absolute Medical Outcome Study (MOS) Sleep Score at Baseline and Week 24
Description
The MOS-Sleep includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS sleep reflects more of the attribute indicated by the subscale name.
Time Frame
Baseline (Day 1) and Week 24
Title
Change from Baseline in the Absolute Medical Outcome Study (MOS) Sleep Score at Baseline and Week 24
Description
The MOS-Sleep includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Subscales are standardised to yield scores from 0 to 100, with the exception of sleep quantity. Higher scores on the MOS sleep reflects more of the attribute indicated by the subscale name. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1) and Week 24
Title
Absolute Work Productivity and Activity Impairment (WPAI) Score at Week 24
Description
The WPAI questionnaire is an instrument to measure impairments in both paid work and unpaid work. The WPAI questionnaire consists of 6 questions that are used to assess: 1-employment status (yes/no), 2- work time missed due to Psoriasis (hours), 3-work time missed due to other reasons (hours), 4-actual work time (hours), 5-the impact of Psoriasis on work productivity while at work (0:10 point scale), and 6-the impact of Psoriasis on activities outside of work (0:10 point scale) for the 7 days prior to questionnaire completion. Four scores are derived from the questions: percent absenteeism (work time missed), percent presenteeism (impairment at work), percent work productivity loss (overall work impairment due to absenteeism and presenteeism), and percent activity impairment (activities performed outside of work). Higher scores indicate a higher level of impairment.
Time Frame
Week 24
Title
Change from Baseline in the Absolute Work Productivity and Activity Impairment (WPAI) Score at Week 24
Description
The WPAI questionnaire is an instrument to measure impairments in both paid work and unpaid work. The WPAI questionnaire consists of 6 questions that are used to assess: 1-employment status (yes/no), 2- work time missed due to Psoriasis (hours), 3-work time missed due to other reasons (hours), 4-actual work time (hours), 5-the impact of Psoriasis on work productivity while at work (0:10 point scale), and 6-the impact of Psoriasis on activities outside of work (0:10 point scale) for the 7 days prior to questionnaire completion. Four scores are derived from the questions: percent absenteeism (work time missed), percent presenteeism (impairment at work), percent work productivity loss (overall work impairment due to absenteeism and presenteeism), and percent activity impairment (activities performed outside of work). Higher scores indicate a higher level of impairment. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1) and Week 24
Title
Absolute Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Week 24
Description
The TSQM is a 14-item self-reported generic instrument designed to measure participant satisfaction with medication treatment. The 4 scales of the TSQM include the Effectiveness subscale, the Side Effects subscale (items 4-8), the Convenience subscale (items 9-11), and the Global Satisfaction subscale (items 12-14). The last subscale is regarded both in concept and in research as a superordinate, second-order global factor encompassing the other 3 more specific domains of medication experiences. Responses are obtained on a 5-point or a 7-point Likert scale (range, 1 extremely dissatisfied'' to 7 extremely satisfied'') for all but 1 item that has a yes-no response option. The subscale scores are transformed into scores ranging from 0 to 100, with higher scores representing higher satisfaction on that domain. Regarding the Side Effects subscale, when the participant answers no'' to experiencing side effects (item 4), this subscale is scored as 100.
Time Frame
Week 24
Title
Percentage of Participants Achieving a Score Greater Than or Equal to (>=) 1 in the Absolute Patient Benefit Index (PBI) Score at Week 24.
Description
This is a questionnaire of 23 items on participant-relevant therapy needs and benefits. The first part of the instrument, the Participant Needs Questionnaire (PNQ), is filled in by the participant before therapy. A five- step Likert scale (0 = not important at all to 4 = very important) records the individual relevance of the different items to the participant. The second part, the Participant Benefit Questionnaire (PBQ), is filled in by the participants during or after therapy. It comprises the same items as the PNQ, but in contrast, the participants evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0 = treatment did not help at all to 4 = treatment helped a lot). In addition, the Likert scale contains the option does not apply to me in the PNQ and the option did not apply to me in the PBQ. This questionnaire score ranges from 0 = no benefit to 4 = maximal benefit. A PBI value of >=1 is considered as relevant benefit.
Time Frame
Week 24
Title
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Description
An Adverse Event (AE) will be considered as TEAE if it was not present prior to the first dose of the study drug or was present prior to the first dose of study drug, but increased in severity during the treatment period.
Time Frame
Baseline (Day 1) up to Week 28
Title
Absolute High-sensitivity C-Reactive Protein (hs-CRP) at Week 24
Description
The hs-CRP will be assessed as safety serum biochemistry parameters.
Time Frame
Week 24
Title
Change from Baseline in the Absolute High-sensitivity C-Reactive Protein (hs-CRP) at Week 24
Description
The hs-CRP will be assessed as safety serum biochemistry parameters. Change from baseline will be calculated by subtracting post-dose value baseline value.
Time Frame
Baseline (Day 1) and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide signed written and dated informed consent given before any study related activity is performed
Participants with a diagnosis of moderate to severe plaque psoriasis
Participants eligible for systemic biologic treatment as assessed by the investigator or having had a primary/secondary failure to treatment with one or more anti-Tumor Necrosis Factor (TNF) biologic agents for psoriasis
Exclusion Criteria:
Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study
Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®
Women currently pregnant, or intend to become pregnant or breastfeeding. Unwillingness/inability for the participants (women or men) to use appropriate measures of contraception (if necessary)
Other forms of psoriasis than chronic plaque-type
Current severe and/or uncontrolled psoriatic arthritis (PsA), or participants with PsA that is currently receiving systemic treatment
Drug-induced psoriasis at the Screening Visit
Concurrent malignancy, current relevant autoimmune diseases other than psoriasis
Participants with severe renal impairment, haematological abnormality and abnormal liver enzymes at the screening visit
Active infection disease or history of recurrent infection
Active or latent tuberculosis (TB) at Screening visit
Positive test for human immunodeficiency virus or any other immunosuppressive disease
Participants with exposure to psoriasis systemic investigational drugs in the previous year
Live vaccination within 4 weeks prior to the Baseline Visit
Participants who intend to use any concomitant medication with immunomodulating or systemic corticosteroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Almirall, SAS
Official's Role
Study Director
Facility Information:
Facility Name
Investigator Site 9
City
Ancona
Country
Italy
Facility Name
Investigator Site 11
City
Arezzo
Country
Italy
Facility Name
Investigator Site 7
City
Cagliari
Country
Italy
Facility Name
Investigator Site 15
City
Catania
Country
Italy
Facility Name
Investigator Site 14
City
Erice
Country
Italy
Facility Name
Investigator Site 4
City
Genova
Country
Italy
Facility Name
Investigator Site 6
City
L'Aquila
Country
Italy
Facility Name
Investigator Site 12
City
Milano
Country
Italy
Facility Name
Investigator Site 2
City
Modena
Country
Italy
Facility Name
Investigator Site 13
City
Napoli
Country
Italy
Facility Name
Investigator Site 10
City
Novara
Country
Italy
Facility Name
Investigator Site 16
City
Parma
Country
Italy
Facility Name
Investigator Site 18
City
Perugia
Country
Italy
Facility Name
Investigator Site 19
City
Reggio Calabria
Country
Italy
Facility Name
Investigator Site 17
City
Roma
Country
Italy
Facility Name
Investigator Site 3
City
Roma
Country
Italy
Facility Name
Investigator Site 5
City
Roma
Country
Italy
Facility Name
Investigator Site 1
City
Rozzano (MI)
Country
Italy
Facility Name
Investigator Site 8
City
Torino
Country
Italy
Facility Name
Investigator Site 14
City
A Coruña
Country
Spain
Facility Name
Investigator Site 18
City
Albacete
Country
Spain
Facility Name
Investigator Site 12
City
Alicante
Country
Spain
Facility Name
Investigator Site 20
City
Barcelona
Country
Spain
Facility Name
Investigator Site 2
City
Barcelona
Country
Spain
Facility Name
Investigator Site 3
City
Barcelona
Country
Spain
Facility Name
Investigator Site 4
City
Barcelona
Country
Spain
Facility Name
Investigator Site 16
City
Granada
Country
Spain
Facility Name
Investigator Site 22
City
Granada
Country
Spain
Facility Name
Investigator Site 1
City
Las Palmas
Country
Spain
Facility Name
Investigator Site 19
City
Madrid
Country
Spain
Facility Name
Investigator Site 21
City
Madrid
Country
Spain
Facility Name
Investigator Site 6
City
Madrid
Country
Spain
Facility Name
Investigator Site 7
City
Madrid
Country
Spain
Facility Name
Investigator Site 8
City
Madrid
Country
Spain
Facility Name
Investigator Site 9
City
Madrid
Country
Spain
Facility Name
Investigator Site 13
City
Pontevedra
Country
Spain
Facility Name
Investigator Site 11
City
Valencia
Country
Spain
Facility Name
Investigator Site 17
City
Valencia
Country
Spain
Facility Name
Investigator Site 15
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Tildrakizumab 100 Milligrams (mg) in Participants With Moderate-Severe Chronic Plaque Psoriasis and Its Impact on Their Quality of Life (TRIBUTE)
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