| Primary | The Proportion of Subjects With Investigator Global Assessment Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16 | | | Posted | | Number | | proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Cochran-Mantel-Haenszel | | <0.00001 | | | | | | | | | | | | | | Superiority | | |
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| Primary | The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events. | | | Posted | | Number | | Percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | All eligible subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | All eligible subjects will receive Tildrakizumab upto week 52. |
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| Primary | The Percentage of Subjects With Severe Infections, Whether or Not Reported as a Serious Event | defined as any infection meeting regulatory definition of serious adverse event, or any infection requiring intravenous antibiotics whether or not reported as a serious event as per the regulatory definition. | | Posted | | Number | | Percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | All eligible subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | All eligible subjects will receive Tildrakizumab upto week 52. |
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| Primary | The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix). | | | Posted | | Number | | Percentage of participants | | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | All eligible subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | All eligible subjects will receive Tildrakizumab upto week 52. |
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| Primary | The Percentage of Subjects With Melanoma Skin Cancer. | | | Posted | | Number | | Percentage of participants | No | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | All eligible subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | All eligible subjects will receive Tildrakizumab upto week 52. |
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| Primary | The Percentage of Subjects With Major Adverse Cardiovascular Events | | | Posted | | Number | | Percentage of participants | No | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | All eligible subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | All eligible subjects will receive Tildrakizumab upto week 52. |
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| Primary | The Percentage of Subjects With Study Treatment-related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc.). | | | Posted | | Number | | Percentage of participants | No | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | All eligible subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | All eligible subjects will receive Tildrakizumab upto week 52. |
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| Primary | The Percentage of Subjects With Injection Site Reactions (eg, Pain, Erythema, Edema Etc). | | | Posted | | Number | | Percentage of participants | No | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | All eligible subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | All eligible subjects will receive Tildrakizumab upto week 52. |
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| Primary | The Percentage of Subjects With Non-melanoma Skin Cancer | | | Posted | | Number | | Percentage of participants | No | Week 72 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | All eligible subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | All eligible subjects will receive Tildrakizumab upto week 52. |
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| Secondary | The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index at Week 16 | | | Posted | | Number | | proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52 | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Mean Percentage Change in Psoriasis Scalp Severity Index Score From Baseline to Week 16. | Psoriasis Scalp Severity Index (PSSI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling) in the same way as the Psoriasis Area Severity Index (PASI), but for scalp only. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Lesser the score, better is the outcome. | | Posted | | Mean | Standard Deviation | Mean percent change | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52 . | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
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| Secondary | The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 75 at Week 16 | Psoriasis Area and Severity Index is use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling). The PASI includes scores on erythema, thickness, scaling, and percentage of body surface area (BSA) affected. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Current outcome measures proportion of subjects achieving 75% improvement from baseline. | | Posted | | Number | | proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 100 at Week 16 | Psoriasis Scalp Severity Index (PSSI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling) in the same way as the Psoriasis Area Severity Index (PASI), but for scalp only. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Lesser the score, better is the outcome. Current outcome measures 100% improvement in PSSI from baseline. | | Posted | | Number | | proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Mean Percentage Change in Scalp Surface Area (SSA) Involvement From Baseline to Week 16 | | | Posted | | Mean | Standard Deviation | Mean percent change in SSA | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
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| Secondary | Time to 75% Reduction in Psoriasis Scalp Severity Index During 16-week Placebo-controlled Treatment Period. | Psoriasis Scalp Severity Index (PSSI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling) in the same way as the Psoriasis Area Severity Index (PASI), but for scalp only. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Current outcome measure is time to PSSI 75. Lesser the time required, better is the effect of drug. | | Posted | | Median | Inter-Quartile Range | Time (days) | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Time to Investigator Global Assessment Mod 2011 (Scalp ) Response During the 16-week Placebo-controlled Treatment Period. | Investigator Global Assessment Mod 2011 (Scalp) is a 5-point scale that is static (refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit). Score ranges from 0-4. lower the score is better. Traetment success is considered when IGA Mod 2011 (Scale) is 0 or 1 with 2 point reduction from baseline score. current outcome measures time to treatment success. | | Posted | | Median | Inter-Quartile Range | Time (days) | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
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| Secondary | Proportion of Subjects Achieving a 4-point Reduction in Itch Numeric Rating Scale Score From Baseline to Week 16 | | | Posted | | Number | | Proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
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| Secondary | The Proportion of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75, Psoriasis Area and Severity Index 90, and Psoriasis Area and Severity Index 100 at Week 16 | Psoriasis Area and Severity Index is use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling). The PASI includes scores on erythema, thickness, scaling, and percentage of body surface area (BSA) affected. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Current outcome measures proportion of subjects achieving 75%, 90% and 100% improvement from baseline, respectively. | | Posted | | Number | | Proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
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| Secondary | The Proportion of Subjects With Physician's Global Assessment Score (Whole Body) Score of "Clear" or "Almost Clear" With at Least a 2-point Reduction From Baseline to Week 16 | | | Posted | | Number | | Proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Mean Percentage Change in Total Body Surface Area (BSA) Involvement From Baseline to Week 16 | | | Posted | | Mean | Standard Deviation | Mean percent change in BSA | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | The Proportion of Subjects With Investigator Global Assessment (Scalp Only) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16. | | | Posted | | Number | | Proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | The Proportion of Subjects With Investigator Global Assessment Mod 2011 Score (Whole Body) of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline at Week 16 | | | Posted | | Number | | Proportion of subjects | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
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| Secondary | The Proportion of Subjects With IGA Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline | | | Posted | | Number | | Proportion of subjects | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index | | | Posted | | Number | | Proportion of subjects | | week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Comparator: Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52 | | | Posted | | Count of Participants | | Participants | No | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
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| Secondary | Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52 | | | Posted | | Count of Participants | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Mean Change in Psoriasis Scalp Severity Index Score From Baseline at Week 52 | Psoriasis Scalp Severity Index (PSSI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling) in the same way as the Psoriasis Area Severity Index (PASI), but for scalp only. The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Lesser the score, better is the outcome. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52 | | | Posted | | Count of Participants | | Participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Change From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 52 | The Scalp Itch NRS is a self-administered, single item questionnaire with response options from 0=No Itch to 10=Worst itch imaginable. A higher score on the NRS corresponds to greater scalp itch severity. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Mean Change in PASI Score From Baseline at Week 52 | Psoriasis Area Severity Index (PASI) use a 5-point scale to grade the 3 clinical parameters (erythema, thickness, and scaling). The parameter scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The score ranges from 0-72. Outcome measures percentage change in score from baseline. Lesser the score, better is the outcome. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |
| Secondary | Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52 | | | Posted | | Count of Participants | | Participants | No | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
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| Other Pre-specified | Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52 | The DLQI questionnaire is used to assess treatment response on the subject's quality of life. The aim of this questionnaire is to measure how much the skin condition has affected the subject's life during the previous week. Subjects are asked to recall their experiences during the previous week by responding to 10 questions. The questionnaire is self-explanatory and handed to the subject who is asked to fill it in without the need for a detailed explanation. DLQI is calcualted by summing the score of each question resulting in a maximum of 30 and minimum of 0. The higher the score, the more quality of life is impaired. | | Posted | | Mean | Standard Deviation | score on a scale | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Subjects will receive Placebo injections upto week 4. At Week 16, all the subjects from this arm were switched to receive Tildrakizumab upto week 52. | | OG001 | Tildrakizumab | Subjects will receive Tildrakizumab upto week 52 |
| |