A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis

Study Overview
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Brief Summary
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This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week 16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks, excluding a screening period.

Official Title
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An Open-Label, Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Moderate to Severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Injections of tildrakizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are non-immunocompromised males or females 18 years of age or older. Subjects have ≥3% total body surface area plaque psoriasis. Subjects are candidates for phototherapy or systemic therapy. Subject must be diagnosed at least 6 months prior to entering the study. Females must be surgically sterile, postmenopausal for >5 years, or using a highly effective form of birth control (<1% failure rate), for at least 30 days prior to test article exposure, with a negative serum pregnancy test. Exclusion Criteria: Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject is younger than 18 years of age. Subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice. Subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator. Subject is currently enrolled in an investigational drug or device study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: tildrakizumab 100 mg<br> | Drug: Injections of tildrakizumab<br>* given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale | The Psychological General Well-Being scale is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients. The values reported are change in score from baseline. | baseline, week 28 and week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time | The Psychological General Well-Being scale is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients. The values reported are change in score from baseline. | baseline, weeks 4, 8, 12, 16, 40, 64 | 
| Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time | The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life | week 64 | 
| Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1 | The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100. | baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 | 
| Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5 | The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100. | Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline | The DLQI is a self-administered and user-friendly validated questionnaire used to measure the health-related quality of life of adult patients suffering from a skin disease. The items of the DLQI encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and the side effects of treatment. Higher scores mean greater impairment of patient's QoL. The DLQI or Dermatology Life Quality Index measures patient's quality of life. The score ranges from 0 to 30. Lower scores indicate less impairment in quality of life. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100 | baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Changes From Baseline in Percent Affected Body Surface Area | The percent BSA affected with psoriasis will be estimated at each study visit. The investigator may use the estimate that 1% BSA is equivalent to the area of the subject's closed hand (palm with fingers held together). | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Change From Baseline in Static Physician's Global Assessment | The sPGA is used to determine the overall severity of psoriasis lesions at a given time point. Its score ranges from 0 to 5 with higher scores indicating greater severity. | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time | The metric of BSA x sPGA is a multiplication of the percentage BSA covered and the sPGA score. The scale range for the sPGA is 0 to 5. The scale range for BSA in this study was >=3% (inclusion criterion), which means that it has to be at least 3%, and it can be as high as 100% hypothetically. So the minimum score for sPGA x BSA = 0, and the maximum score is 5 x 100 = 500. So the range for sPGA x BSA in this study was 0 to 500. The BSA has a range of 0% to 100% where higher percentages indicate a worse outcome or worse disease The sPGA has a range of 0 (clear) to 5 (severe) where higher values indicate a worse outcome or worse disease. sPGA is used to determine the overall severity of psoriasis lesions at a given time point. Its score ranges from 0 to 5. BSA covered is reported as percent of body surface area covered. Total score for BSA x sPGA ranges from 0 to 500 with higher scores indicating greater severity. | weeks 4, 8, 12, 16, 28, 40, 52, 64 | 
| Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time | The PASI is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI analyzes the four regions of the body (head, trunk, upper and lower limbs). It ranges from 0 to 72 with higher scores indicating greater severity. | baseline, weeks 4,16, 28 and 52 | 
| Change From Baseline in Itch-Numeric Rating Scale | The Itch-Numerical Rating Scale (I-NRS) is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no itch and score of 10 indicates indicates worst imaginable itch | baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 | 
| Change From Baseline in Scaling-Numeric Rating Scale | The Scaling-NRS (S-NRS) is a simple, 11-point self-administered numeric rating scale that is administered at each visit. A score of 0 represents 'no scaling' and a score of 10, indicates 'worst scaling imaginable'. | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Change From Baseline in Pain-Numeric Rating Scale | The P-NRS is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no pain. A score of 10 indicates worst pain imaginable | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Proportion of Patients With Itch Score of 0 | The Itch-Numerical Rating Scale (I-NRS) is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no itch and score of 10 indicates indicates worst imaginable itch. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100 | weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Proportion of Patients With Scaling Score of 0 | The Scaling-NRS (S-NRS) is a simple, 11-point self-administered numeric rating scale that is administered at each visit. A score of 0 represents 'no scaling' and a score of 10, indicates 'worst scaling imaginable'. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100 | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Proportion of Patients With Pain Score of 0 | The P-NRS is a simple, 11-point self-administered numeric rating scale. A score of 0 indicates no pain. A score of 10 indicates worst pain imaginable. For 'Units of Measure'- Data entered is percentage of participants, which is calculated by multiplying the value obtained (Proportion in this case) by 100. | Weeks 4, 8, 12, 16, 28, 40, 52, and 64 | 
| Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time | The WPAI is a validated, subject-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism, presenteeism, total activity impairment , and total work productivity impairment. Each WPAI score is expressed as impairment percentages (0-100), with higher scores indicating greater impairment (worse outcomes). | baseline, weeks 16, 28, 40, 52, 64 | 
| Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time | The TSQM is a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. The 14-item TSQM Version 1.4 is a reliable and valid instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. The TSQM domain scores range from 0-100 with higher scores representing higher satisfaction on that domain | baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64 | 
| Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales | The Tildrakizumab Overall Satisfaction Scale is an 11-point simple, self-administered numeric rating scale. Subjects indicate their overall satisfaction by circling the integer that best describes their experience on a scale. A score of 0 indicates 'not satisfied' and 10 indicates 'extremely satisfied'. | weeks 4, 8, 12, 16, 28, 40, 52, 64 | 
| Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale | The Patient Happiness with Psoriasis Control assessment is an 11-point simple, self- administered numeric rating scale ranging in score from 0 to 10 that is administered at each visit. Subjects indicate their overall happiness with psoriasis control by circling the integer that best describes their experience on a scale. A score of 0 indicates 'extremely unhappy'. A score of 10 indicates 'extremely happy'. | weeks 4, 8, 12, 16, 28, 40, 52, 64 |