Trial Outcomes & Findings for Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis (NCT NCT03897088)
NCT ID: NCT03897088
Last Updated: 2023-05-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
231 participants
Primary outcome timeframe
Week 16
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
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.
|
Tildrakizumab
All eligible subjects will receive Tildrakizumab upto week 52.
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
117
|
|
Overall Study
COMPLETED
|
88
|
86
|
|
Overall Study
NOT COMPLETED
|
26
|
31
|
Reasons for withdrawal
| Measure |
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.
|
Tildrakizumab
All eligible subjects will receive Tildrakizumab upto week 52.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
|
Overall Study
Lost to Follow-up
|
7
|
15
|
|
Overall Study
Sponsor Decision
|
1
|
2
|
|
Overall Study
COVID-19
|
2
|
0
|
|
Overall Study
Other
|
3
|
0
|
|
Overall Study
Non-compliance with Study Drug
|
1
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=114 Participants
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 52.
|
Tildrakizumab
n=117 Participants
All eligible subjects will receive Tildrakizumab upto week 52
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 12.96 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 15.27 • n=7 Participants
|
45.2 years
STANDARD_DEVIATION 14.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Placebo Comparator: Placebo
n=82 Participants
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.
|
Tildrakizumab
n=89 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
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
|
0.073 proportion of subjects
|
0.494 proportion of subjects
|
PRIMARY outcome
Timeframe: Week 72Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.
Incidence of TEAEs
|
51.8 Percentage of participants
|
53 Percentage of participants
|
|
The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.
Serious TEAEs
|
3.5 Percentage of participants
|
2.6 Percentage of participants
|
|
The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.
Severity - Mild
|
45.6 Percentage of participants
|
40.1 Percentage of participants
|
|
The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.
Severity - Moderate
|
21.1 Percentage of participants
|
18.8 Percentage of participants
|
|
The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.
Severity- Severe
|
1.7 Percentage of participants
|
0.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 72defined 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Percentage of Subjects With Severe Infections, Whether or Not Reported as a Serious Event
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 72Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).
|
0 Percentage of participants
|
1.71 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 72Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Percentage of Subjects With Melanoma Skin Cancer.
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 72Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Percentage of Subjects With Major Adverse Cardiovascular Events
|
1.75 Percentage of participants
|
0.85 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 72Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Percentage of Subjects With Study Treatment-related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc.).
|
1.75 Percentage of participants
|
0.85 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 72Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Percentage of Subjects With Injection Site Reactions (eg, Pain, Erythema, Edema Etc).
|
0.88 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 72Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Percentage of Subjects With Non-melanoma Skin Cancer
|
0 Percentage of participants
|
2 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index at Week 16
|
0.044 proportion of subjects
|
0.56 proportion of subjects
|
SECONDARY outcome
Timeframe: Week 16Psoriasis 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=107 Participants
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.
|
Tildrakizumab
n=110 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Mean Percentage Change in Psoriasis Scalp Severity Index Score From Baseline to Week 16.
|
-21.84 Mean percent change
Standard Deviation 35.577
|
-79.81 Mean percent change
Standard Deviation 30.434
|
SECONDARY outcome
Timeframe: Week 16Psoriasis 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 75 at Week 16
|
0.105 proportion of subjects
|
0.709 proportion of subjects
|
SECONDARY outcome
Timeframe: Week 16Psoriasis 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 100 at Week 16
|
0.026 proportion of subjects
|
0.376 proportion of subjects
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Placebo Comparator: Placebo
n=107 Participants
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.
|
Tildrakizumab
n=110 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Mean Percentage Change in Scalp Surface Area (SSA) Involvement From Baseline to Week 16
|
-15.20 Mean percent change in SSA
Standard Deviation 31.473
|
-76.39 Mean percent change in SSA
Standard Deviation 35.179
|
SECONDARY outcome
Timeframe: Week 16Psoriasis 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Time to 75% Reduction in Psoriasis Scalp Severity Index During 16-week Placebo-controlled Treatment Period.
|
NA Time (days)
Not estimable due to insufficient number of non-censored observations
|
59 Time (days)
Interval 54.0 to 113.0
|
SECONDARY outcome
Timeframe: Week 16Investigator 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=82 Participants
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.
|
Tildrakizumab
n=89 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Time to Investigator Global Assessment Mod 2011 (Scalp ) Response During the 16-week Placebo-controlled Treatment Period.
|
NA Time (days)
Not estimable due to insufficient number of non-censored observations
|
86 Time (days)
Interval 57.0 to 115.0
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Placebo Comparator: Placebo
n=102 Participants
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.
|
Tildrakizumab
n=101 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Proportion of Subjects Achieving a 4-point Reduction in Itch Numeric Rating Scale Score From Baseline to Week 16
|
0.147 Proportion of subjects
|
0.545 Proportion of subjects
|
SECONDARY outcome
Timeframe: Week 16Psoriasis 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
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
PASI-75
|
0.079 Proportion of subjects
|
0.667 Proportion of subjects
|
|
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
PASI-90
|
0.026 Proportion of subjects
|
0.41 Proportion of subjects
|
|
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
PASI-100
|
0.009 Proportion of subjects
|
0.162 Proportion of subjects
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
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
|
0.062 Proportion of subjects
|
0.556 Proportion of subjects
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Placebo Comparator: Placebo
n=107 Participants
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.
|
Tildrakizumab
n=110 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Mean Percentage Change in Total Body Surface Area (BSA) Involvement From Baseline to Week 16
|
0.19 Mean percent change in BSA
Standard Deviation 39.039
|
-70.17 Mean percent change in BSA
Standard Deviation 33.443
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
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.
|
0.106 Proportion of subjects
|
0.684 Proportion of subjects
|
SECONDARY outcome
Timeframe: Week 16Outcome measures
| Measure |
Placebo Comparator: Placebo
n=82 Participants
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.
|
Tildrakizumab
n=89 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
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
|
0.038 Proportion of subjects
|
0.545 Proportion of subjects
|
SECONDARY outcome
Timeframe: Week 12Outcome measures
| Measure |
Placebo Comparator: Placebo
n=82 Participants
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.
|
Tildrakizumab
n=89 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Proportion of Subjects With IGA Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline
|
0.049 Proportion of subjects
|
0.461 Proportion of subjects
|
SECONDARY outcome
Timeframe: week 12Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index
|
0.018 Proportion of subjects
|
0.427 Proportion of subjects
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
| Measure |
Placebo Comparator: Placebo
n=68 Participants
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.
|
Tildrakizumab
n=77 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
1 = Worsen by 1
|
0 Participants
|
0 Participants
|
|
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
0 = No Change
|
1 Participants
|
2 Participants
|
|
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
-1 = Improve by 1
|
14 Participants
|
13 Participants
|
|
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
-2 = Improve by 2
|
9 Participants
|
9 Participants
|
|
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
-3 = Improve by 3
|
38 Participants
|
48 Participants
|
|
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
-4 = Improve by 4
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
| Measure |
Placebo Comparator: Placebo
n=65 Participants
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.
|
Tildrakizumab
n=76 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
1 = Worsen by 1
|
0 Participants
|
0 Participants
|
|
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
0 = No Change
|
6 Participants
|
5 Participants
|
|
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
-1 = Improve by 1
|
15 Participants
|
18 Participants
|
|
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
-2 = Improve by 2
|
15 Participants
|
18 Participants
|
|
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
-3 = Improve by 3
|
26 Participants
|
33 Participants
|
|
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
-4 = Improve by 4
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 52Psoriasis 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Mean Change in Psoriasis Scalp Severity Index Score From Baseline at Week 52
|
-30.4 score on a scale
Standard Deviation 15.39
|
-31.1 score on a scale
Standard Deviation 13.96
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
| Measure |
Placebo Comparator: Placebo
n=97 Participants
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.
|
Tildrakizumab
n=100 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
-3 = Improve by 3
|
58 Participants
|
66 Participants
|
|
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
1 = Worsen by 1
|
1 Participants
|
0 Participants
|
|
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
0 = No Change
|
4 Participants
|
3 Participants
|
|
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
-1 = Improve by 1
|
8 Participants
|
8 Participants
|
|
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
-2 = Improve by 2
|
18 Participants
|
14 Participants
|
|
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
-4 = Improve by 4
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 52The 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Change From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 52
|
-5.0 score on a scale
Standard Deviation 3.04
|
-4.7 score on a scale
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: Week 52Psoriasis 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Mean Change in PASI Score From Baseline at Week 52
|
-16.43 score on a scale
Standard Deviation 7.901
|
-16.84 score on a scale
Standard Deviation 6.072
|
SECONDARY outcome
Timeframe: Week 52Outcome measures
| Measure |
Placebo Comparator: Placebo
n=96 Participants
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.
|
Tildrakizumab
n=100 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
1 = Worsen by 1
|
1 Participants
|
6 Participants
|
|
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
0 = No Change
|
8 Participants
|
12 Participants
|
|
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
-1 = Improve by 1
|
15 Participants
|
12 Participants
|
|
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
-2 = Improve by 2
|
26 Participants
|
27 Participants
|
|
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
-3 = Improve by 3
|
38 Participants
|
49 Participants
|
|
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
-4 = Improve by 4
|
8 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52The 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.
Outcome measures
| Measure |
Placebo Comparator: Placebo
n=114 Participants
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.
|
Tildrakizumab
n=117 Participants
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52
Total
|
-12.5 score on a scale
Standard Deviation 6.74
|
-11.5 score on a scale
Standard Deviation 7.51
|
|
Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52
Symptoms and Feelings
|
-3.4 score on a scale
Standard Deviation 1.27
|
-3.2 score on a scale
Standard Deviation 1.61
|
|
Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52
Daily Activities
|
-2.8 score on a scale
Standard Deviation 1.62
|
-2.6 score on a scale
Standard Deviation 1.90
|
|
Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52
Leisure
|
-2.4 score on a scale
Standard Deviation 1.93
|
-2.2 score on a scale
Standard Deviation 2.03
|
|
Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52
Work and School
|
-0.9 score on a scale
Standard Deviation 1.09
|
-0.9 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52
Personal Relationships
|
-1.8 score on a scale
Standard Deviation 1.86
|
-1.7 score on a scale
Standard Deviation 1.97
|
|
Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52
Treatment
|
-1.1 score on a scale
Standard Deviation 1.26
|
-0.9 score on a scale
Standard Deviation 1.12
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo to Tildrakizumab
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Tildrakizumab
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=114 participants at risk
Subjects will receive Placebo injections upto week 4.
|
Placebo to Tildrakizumab
n=114 participants at risk
At week 16, subjects initially randomized to placebo were switched to receive Tildrakizumab upto Week 52
|
Tildrakizumab
n=117 participants at risk
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/114 • 72 weeks
|
0.88%
1/114 • 72 weeks
|
0.85%
1/117 • 72 weeks
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
0.85%
1/117 • 72 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
0.85%
1/117 • 72 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/114 • 72 weeks
|
0.88%
1/114 • 72 weeks
|
0.00%
0/117 • 72 weeks
|
|
Injury, poisoning and procedural complications
Exposure during pregnancy
|
0.00%
0/114 • 72 weeks
|
0.88%
1/114 • 72 weeks
|
0.00%
0/117 • 72 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
0.85%
1/117 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/114 • 72 weeks
|
0.88%
1/114 • 72 weeks
|
0.00%
0/117 • 72 weeks
|
Other adverse events
| Measure |
Placebo
n=114 participants at risk
Subjects will receive Placebo injections upto week 4.
|
Placebo to Tildrakizumab
n=114 participants at risk
At week 16, subjects initially randomized to placebo were switched to receive Tildrakizumab upto Week 52
|
Tildrakizumab
n=117 participants at risk
Subjects will receive Tildrakizumab upto week 52
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.88%
1/114 • 72 weeks
|
4.4%
5/114 • 72 weeks
|
4.3%
5/117 • 72 weeks
|
|
Infections and infestations
Covid-19
|
0.00%
0/114 • 72 weeks
|
3.5%
4/114 • 72 weeks
|
3.4%
4/117 • 72 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/114 • 72 weeks
|
1.8%
2/114 • 72 weeks
|
2.6%
3/117 • 72 weeks
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.88%
1/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
3.4%
4/117 • 72 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
2.6%
3/117 • 72 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/114 • 72 weeks
|
1.8%
2/114 • 72 weeks
|
0.00%
0/117 • 72 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Investigations
Sars-Cov-2 Test Positive
|
0.00%
0/114 • 72 weeks
|
1.8%
2/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
0.85%
1/117 • 72 weeks
|
|
Investigations
Blood Triglycerides Increased
|
1.8%
2/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
0.00%
0/117 • 72 weeks
|
|
Investigations
Weight Increased
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Nervous system disorders
Headache
|
3.5%
4/114 • 72 weeks
|
1.8%
2/114 • 72 weeks
|
2.6%
3/117 • 72 weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Vascular disorders
Hypertension
|
0.88%
1/114 • 72 weeks
|
1.8%
2/114 • 72 weeks
|
5.1%
6/117 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
2/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
0.85%
1/117 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/114 • 72 weeks
|
1.8%
2/114 • 72 weeks
|
0.00%
0/117 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
3/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Immune system disorders
Seasonal Allergy
|
0.88%
1/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
2.6%
3/117 • 72 weeks
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
0.85%
1/117 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
2/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
0.00%
0/117 • 72 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/114 • 72 weeks
|
0.00%
0/114 • 72 weeks
|
1.7%
2/117 • 72 weeks
|
Additional Information
Head-Clinical Development
Sun Pharmaceutical Industries Limited
Phone: 2266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place