This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe psoriasis of the scalp.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
all eligible subjects will receive either tildrakizumab or placebo
subjects initially on placebo will be switched over to receive tildrakizumab while subjects initially on tildrakizumab will continue to receive tildrakizumab as per defined schedule
SPARC Site 18
Encinitas, California, United States
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
Time frame: Week 16
The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.
Time frame: Week 72
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.
Time frame: Week 72
The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).
Time frame: Week 72
The Percentage of Subjects With Melanoma Skin Cancer.
Time frame: Week 72
The Percentage of Subjects With Major Adverse Cardiovascular Events
Time frame: Week 72
The Percentage of Subjects With Study Treatment-related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc.).
Time frame: Week 72
The Percentage of Subjects With Injection Site Reactions (eg, Pain, Erythema, Edema Etc).
Time frame: Week 72
The Percentage of Subjects With Non-melanoma Skin Cancer
Time frame: Week 72
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SPARC Site 7
Fountain Valley, California, United States
SPARC Site 3
Fremont, California, United States
SPARC Site 12
Huntington Beach, California, United States
SPARC Site 9
Los Angeles, California, United States
SPARC Site 2
Los Angeles, California, United States
SPARC Site 14
Santa Monica, California, United States
SPARC Site 21
Coral Gables, Florida, United States
SPARC Site 19
Margate, Florida, United States
SPARC Site 5
Sweetwater, Florida, United States
...and 15 more locations
The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index at Week 16
Time frame: Week 16
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.
Time frame: Week 16
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.
Time frame: Week 16
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.
Time frame: Week 16
Mean Percentage Change in Scalp Surface Area (SSA) Involvement From Baseline to Week 16
Time frame: Week 16
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.
Time frame: Week 16
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.
Time frame: Week 16
Proportion of Subjects Achieving a 4-point Reduction in Itch Numeric Rating Scale Score From Baseline to Week 16
Time frame: Week 16
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.
Time frame: Week 16
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
Time frame: Week 16
Mean Percentage Change in Total Body Surface Area (BSA) Involvement From Baseline to Week 16
Time frame: Week 16
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.
Time frame: Week 16
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
Time frame: Week 16
The Proportion of Subjects With IGA Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline
Time frame: Week 12
The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index
Time frame: week 12
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
Time frame: Week 52
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
Time frame: Week 52
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.
Time frame: Week 52
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
Time frame: Week 52
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.
Time frame: Week 52
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.
Time frame: Week 52
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
Time frame: Week 52