A Phase 4 interventional study of Injections of tildrakizumab in Psoriasis, sponsored by Sun Pharmaceutical Industries Limited. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by Sun Pharmaceutical Industries Limited · Phase 4, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 55 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Sun Pharmaceutical Industries Limited is the lead sponsor of 58 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 22 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Injections of tildrakizumab
given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
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.
Time frame: baseline, week 28 and week 52
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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'.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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'.
Time frame: 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'.
Time frame: weeks 4, 8, 12, 16, 28, 40, 52, 64
Treatment-emergent AEs
The reported values are entered in the 'Other Adverse events' section
Time frame: baseline, weeks 4, 8, 12, 16, 28, 40, 52,,64
| Milestone | Tildrakizumab 100 mg |
|---|---|
| Started | 55 |
| Completed | 45 |
| Not completed | 10 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Physician decision | 2 |
| Withdrew: Lost to follow-up | 1 |
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.
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline | 78 ± 14 |
| Week 28 | 3.7 ± 12.36 |
| Week 52 | 8.0 ± 14.06 |
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.
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline | 78.1 ± 14.06 |
| Week 4 | 4.2 ± 10.40 |
| Week 8 | 4.2 ± 12.33 |
| Week 12 | 4.5 ± 13.56 |
| Week 16 | 5.3 ± 13.36 |
| Week 40 | 5.6 ± 12.48 |
| Week 64 | 5.6 ± 14.14 |
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
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time | -8.0 ± 5.18 |
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.
| Percentage of subjects | Tildrakizumab 100 mg |
|---|---|
| Baseline | 1.8 |
| Week 4 | 18.2 |
| Week 8 | 36.5 |
| Week 12 | 42.3 |
| Week 16 | 51.9 |
| Week 28 | 52.8 |
| Week 40 | 58.3 |
| Week 52 | 56.3 |
| Week 64 | 62.2 |
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.
| Percentage of subjects | Tildrakizumab 100 mg |
|---|---|
| Baseline | 13 |
| Week 4 | 56.4 |
| Week 8 | 84.6 |
| Week 12 | 86.5 |
| Week 16 | 88.9 |
| Week 28 | 94.3 |
| Week 40 | 91.7 |
| Week 52 | 89.6 |
| Week 60 | 93.3 |
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
| Percentage of subjects | Tildrakizumab 100 mg |
|---|---|
| Week 4 | 44.4 |
| Week 8 | 61.9 |
| Week 12 | 69.0 |
| Week 16 | 75.0 |
| Week 28 | 81.4 |
| Week 40 | 87.5 |
| Week 52 | 82.5 |
| Week 64 | 78.9 |
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).
| Percent BSA | Tildrakizumab 100 mg |
|---|---|
| Baseline | 14.5 ± 11.54 |
| Week 4 | -2.9 ± 5.70 |
| Week 8 | -8.7 ± 11.89 |
| Week 12 | -10.1 ± 12.09 |
| Week 16 | -10.9 ± 11.57 |
| Week 28 | -10.9 ± 12.74 |
| Week 40 | -11.3 ± 12.93 |
| Week 52 | -11.5 ± 12.79 |
| Week 64 | -12.7 ± 11.88 |
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.
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline | 3.2 ± 0.56 |
| Week 4 | -1.1 ± 0.71 |
| Week 8 | -1.8 ± 0.94 |
| Week 12 | -2.0 ± 1.08 |
| Week 16 | -1.9 ± 0.80 |
| Week 28 | -2.0 ± 1.05 |
| Week 40 | -2.2 ± 1.00 |
| Week 52 | -2.1 ± 1.07 |
| Week 64 | -2.2 ± 1.00 |
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.
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Week 4 | -21.1 ± 27.47 |
| Week 8 | -37.1 ± 42.52 |
| Week 12 | -38.1 ± 43.36 |
| Week 16 | -39.9 ± 41.74 |
| Week 28 | -37.8 ± 45.28 |
| Week 40 | -38.2 ± 44.48 |
| Week 52 | -40.0 ± 44.33 |
| Week 64 | -43.3 ± 41.86 |
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.
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline | 11.6 ± 7.12 |
| Week 4 | -5.1 ± 4.60 |
| Week 16 | -9.3 ± 7.03 |
| Week 28 | -9.4 ± 6.95 |
| Week 52 | -10.0 ± 7.32 |
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
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline | 6.6 ± 2.57 |
| Week 4 | -1.7 ± 2.47 |
| Week 8 | -2.8 ± 3.11 |
| Week 12 | -3.0 ± 3.22 |
| Week 16 | -3.8 ± 2.84 |
| Week 28 | -3.8 ± 3.12 |
| Week 40 | -3.7 ± 2.99 |
| Week 52 | -4.1 ± 3.06 |
| Week 64 | -4.4 ± 2.66 |
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'.
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline | 7.0 ± 2.33 |
| Week 4 | -2.6 ± 2.38 |
| Week 8 | -4.1 ± 3.03 |
| Week 12 | -4.3 ± 2.95 |
| Week 16 | -4.5 ± 2.54 |
| Week 28 | -4.7 ± 2.78 |
| Week 40 | -4.5 ± 2.86 |
| Week 52 | -4.6 ± 2.86 |
| Week 64 | -4.6 ± 2.89 |
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
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline | 3.8 ± 3.22 |
| Week 4 | -1.2 ± 2.65 |
| Week 8 | -1.8 ± 3.18 |
| Week 12 | -1.8 ± 2.88 |
| Week 16 | -2.2 ± 2.88 |
| Week 28 | -2.3 ± 3.05 |
| Week 40 | -2.3 ± 2.48 |
| Week 52 | -2.5 ± 2.76 |
| Week 64 | -2.8 ± 2.75 |
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
| Percentage of participants | Tildrakizumab 100 mg |
|---|---|
| Baseline | 1.8 |
| Week 4 | 3.6 |
| Week 8 | 11.3 |
| Week 12 | 22.2 |
| Week 16 | 16.7 |
| Week 28 | 20.8 |
| Week 40 | 22.9 |
| Week 52 | 22.9 |
| Week 64 | 24.4 |
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
| percentage of participants | Tildrakizumab 100 mg |
|---|---|
| Baseline | 0 |
| Week 4 | 3.6 |
| Week 8 | 20.8 |
| Week 12 | 16.7 |
| Week 16 | 20.4 |
| Week 28 | 22.6 |
| Week 40 | 22.9 |
| Week 52 | 25.0 |
| Week 64 | 17.8 |
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.
| Percentage of participants | Tildrakizumab 100 mg |
|---|---|
| Baseline | 12.7 |
| Week 4 | 21.8 |
| Week 8 | 34.0 |
| Week 12 | 48.1 |
| Week 16 | 40.7 |
| Week 28 | 50.9 |
| Week 40 | 54.2 |
| Week 52 | 52.1 |
| Week 64 | 48.9 |
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).
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline (Total Activity Impairment) | 29.5 ± 26.56 |
| Week 16 (Total Activity Impairment) | -20.8 ± 21.47 |
| Week 28 (Total Activity Impairment) | -24.7 ± 25.47 |
| Week 40 (Total Activity Impairment) | -26.9 ± 24.33 |
| Week 52 (Total Activity Impairment) | -20.8 ± 28.57 |
| Week 64 Total Activity Impairment) | -27.8 ± 22.85 |
| Baseline (Total Work Productivity Impairment) | 20.9 ± 22.21 |
| Week 16 (Total Work Productivity Impairment) | -13.7 ± 21.02 |
| Week 28 (Total Work Productivity Impairment) | -14.5 ± 20.45 |
| Week 40 (Total Work Productivity Impairment) | 17.1 ± 19.33 |
| Week 52 (Total Work Productivity Impairment) | -16.4 ± 22.42 |
| Week 64 (Total Work Productivity Impairment) | -19.4 ± 20.81 |
| Baseline (Absenteeism) | 1.1 ± 5.66 |
| Week 16 (Absenteeism) | 0.5 ± 3.85 |
| Week 28 (Absenteeism) | -0.3 ± 1.93 |
| Week 40 (Absenteeism) | -0.4 ± 2.00 |
| Week 52 (Absenteeism) | -0.4 ± 2.00 |
| Week 64 (Absenteeism) | 0.0 ± 0.00 |
| Baseline (Presenteeism) | 20.5 ± 21.67 |
| Week 16 (Presenteeism) | -14.0 ± 20.47 |
| Week 28 (Presenteeism) | -14.2 ± 20.31 |
| Week 40 (Presenteeism) | -16.8 ± 19.22 |
| Week 52 (Presenteeism) | -16.1 ± 22.31 |
| Week 64 (Presenteeism) | -19.4 ± 20.81 |
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
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Week 4 (Effectiveness) | 59.5 ± 17.03 |
| Week 8 (Effectiveness) | 70.8 ± 23.12 |
| Week 12 (Effectiveness) | 71.0 ± 22.65 |
| Week 16 (Effectiveness) | 73.9 ± 17.39 |
| Week 28 (Effectiveness) | 76.5 ± 19.93 |
| Week 40 (Effectiveness) | 78.4 ± 16.01 |
| Week 52 (Effectiveness) | 78.7 ± 16.89 |
| Week 64 (Effectiveness) | 79.5 ± 20.06 |
| Week 4 (Convenience) | 83.3 ± 15.89 |
| Week 8 (Convenience) | 85.1 ± 14.33 |
| Week 12 (Convenience) | 86.9 ± 13.70 |
| Week 16 (Convenience) | 84.0 ± 12.57 |
| Week 28 (Convenience) | 85.1 ± 13.42 |
| Week 40 (Convenience) | 85.6 ± 13.93 |
| Week 52 (Convenience) | 85.2 ± 13.58 |
| Week 64 (Convenience) | 82.2 ± 16.35 |
| Week 4 (Global Satisfaction) | 72.7 ± 18.55 |
| Week 8 (Global Satisfaction) | 77.5 ± 21.19 |
| Week 12 (Global Satisfaction) | 77.4 ± 20.89 |
| Week 16 (Global Satisfaction) | 79.4 ± 16.69 |
| Week 28 (Global Satisfaction) | 80.5 ± 17.78 |
| Week 40 (Global Satisfaction) | 81.4 ± 15.15 |
| Week 52 (Global Satisfaction) | 81.7 ± 18.40 |
| Week 64 (Global Satisfaction) | 81.9 ± 20.47 |
| Week 4 (Side Effects) | 70.8 ± 14.61 |
| Week 8 (Side Effects) | 78.1 ± 18.75 |
| Week 12 (Side Effects) | 73.4 ± 11.83 |
| Week 16 (Side Effects) | 68.8 ± 6.25 |
| Week 28 (Side Effects) | 81.3 ± 10.83 |
| Week 40 (Side Effects) | 81.3 ± 6.25 |
| Week 52 (Side Effects) | 77.1 ± 9.55 |
| Week 64 (Side Effects) | 79.2 ± 3.61 |
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'.
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Week 4 (Improvement in Symptoms) | 6.0 ± 2.36 |
| Week 8 (Improvement in Symptoms) | 7.6 ± 2.44 |
| Week 12 (Improvement in Symptoms) | 7.7 ± 2.45 |
| Week 16 (Improvement in Symptoms) | 8.0 ± 2.03 |
| Week 28 (Improvement in Symptoms) | 8.0 ± 2.30 |
| Week 40 (Improvement in Symptoms) | 8.4 ± 1.85 |
| Week 52 (Improvement in Symptoms) | 8.4 ± 2.15 |
| Week 64 (Improvement in Symptoms) | 8.7 ± 2.01 |
| Week 4 (Speed of Symptom Improvement) | 5.9 ± 2.39 |
| Week 8 (Speed of Symptom Improvement) | 7.5 ± 2.55 |
| Week 12 (Speed of Symptom Improvement) | 7.2 ± 2.80 |
| Week 16 (Speed of Symptom Improvement) | 7.7 ± 2.15 |
| Week 28 (Speed of Symptom Improvement) | 7.8 ± 2.44 |
| Week 40 (Speed of Symptom Improvement) | 8.4 ± 1.75 |
| Week 52 (Speed of Symptom Improvement) | 7.9 ± 2.36 |
| Week 64 (Speed of Symptom Improvement) | 8.3 ± 2.30 |
| Week 4 (Frequency of Taking Medication) | 7.8 ± 2.05 |
| Week 8 (Frequency of Taking Medication) | 8.4 ± 1.75 |
| Week 12 (Frequency of Taking Medication) | 8.2 ± 2.08 |
| Week 16 (Frequency of Taking Medication) | 8.2 ± 2.19 |
| Week 28 (Frequency of Taking Medication) | 8.3 ± 2.24 |
| Week 40 (Frequency of Taking Medication) | 8.8 ± 2.12 |
| Week 52 (Frequency of Taking Medication) | 8.8 ± 2.12 |
| Week 64 (Frequency of Taking Medication) | 9.1 ± 1.70 |
| Week 4 (Side Effects) | 8.6 ± 2.14 |
| Week 8 (Side Effects) | 9.0 ± 1.50 |
| Week 12 (Side Effects) | 9.2 ± 1.48 |
| Week 16 (Side Effects) | 9.2 ± 1.52 |
| Week 28 (Side Effects) | 9.1 ± 1.54 |
| Week 40 (Side Effects) | 9.3 ± 1.59 |
| Week 52 (Side Effects) | 9.5 ± 1.22 |
| Week 64 (Side Effects) | 9.6 ± 0.68 |
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'.
| score on a scale | Tildrakizumab 100 mg |
|---|---|
| Baseline | 2.7 ± 2.33 |
| Week 4 | 3.7 ± 3.65 |
| Week 8 | 5.1 ± 3.69 |
| Week 12 | 5.1 ± 3.73 |
| Week 16 | 5.5 ± 3.41 |
| Week 28 | 5.7 ± 2.91 |
| Week 40 | 5.9 ± 3.00 |
| Week 52 | 6.0 ± 2.78 |
| Week 64 | 6.0 ± 2.97 |
The reported values are entered in the 'Other Adverse events' section
Results for this outcome have not been posted.
Collected over Week 64. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tildrakizumab 100 mg | 0/55 (0%) | 4/55 (7.3%) | 29/55 (52.7%) |
| Event | Tildrakizumab 100 mg |
|---|---|
| COVID-19 pneumoniaInfections and infestations | 1/55 |
| Transitional cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/55 |
| Ischaemic strokeNervous system disorders | 1/55 |
| IgA nephropathyRenal and urinary disorders | 1/55 |
| Event | Tildrakizumab 100 mg |
|---|---|
| PsoriasisSkin and subcutaneous tissue disorders | 7/55 |
| HypertensionVascular disorders | 5/55 |
| DermatitisSkin and subcutaneous tissue disorders | 3/55 |
| NasopharyngitisInfections and infestations | 2/55 |
| Upper respiratory tract infectionInfections and infestations | 2/55 |
| Large intestine polypGastrointestinal disorders | 2/55 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/55 |
| Skin papillomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/55 |
| HaematuriaRenal and urinary disorders | 2/55 |
| EczemaSkin and subcutaneous tissue disorders | 2/55 |
| Age, Continuous(years) | Tildrakizumab 100 mg |
|---|---|
| Mean | 48.6 ± 15.29 |
| Sex: Female, Male(Participants) | Tildrakizumab 100 mg |
|---|---|
| Female | 27 |
| Male | 28 |
| Ethnicity (NIH/OMB)(Participants) | Tildrakizumab 100 mg |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 50 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Tildrakizumab 100 mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 52 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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