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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03897088
Registration number
NCT03897088
Ethics application status
Date submitted
27/03/2019
Date registered
1/04/2019
Date last updated
31/05/2023
Titles & IDs
Public title
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis
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Scientific title
A Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Plaque Psoriasis of the Scalp
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Secondary ID [1]
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TILD-18-20
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Scalp Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PART 1: Double-blind Placebo-controlled
Treatment: Drugs - PART 2: Double-blind Active Treatment Extension
Experimental: Tildrakizumab -
Placebo Comparator: Placebo -
No Intervention: PART 3: Observational Safety Follow-up - The subjects will not receive study treatment during the follow-up period
Treatment: Drugs: PART 1: Double-blind Placebo-controlled
all eligible subjects will receive either tildrakizumab or placebo
Treatment: Drugs: PART 2: Double-blind Active Treatment Extension
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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Week 16
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Primary outcome [2]
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The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.
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Assessment method [2]
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Timepoint [2]
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Week 72
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Primary outcome [3]
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The Percentage of Subjects With Severe Infections, Whether or Not Reported as a Serious Event
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Assessment method [3]
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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.
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Timepoint [3]
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Week 72
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Primary outcome [4]
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The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).
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Assessment method [4]
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Timepoint [4]
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Week 72
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Primary outcome [5]
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The Percentage of Subjects With Melanoma Skin Cancer.
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Assessment method [5]
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Timepoint [5]
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Week 72
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Primary outcome [6]
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The Percentage of Subjects With Major Adverse Cardiovascular Events
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Assessment method [6]
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Timepoint [6]
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Week 72
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Primary outcome [7]
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The Percentage of Subjects With Study Treatment-related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc.).
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Assessment method [7]
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Timepoint [7]
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Week 72
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Primary outcome [8]
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The Percentage of Subjects With Injection Site Reactions (eg, Pain, Erythema, Edema Etc).
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Assessment method [8]
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Timepoint [8]
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Week 72
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Primary outcome [9]
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The Percentage of Subjects With Non-melanoma Skin Cancer
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Assessment method [9]
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Timepoint [9]
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Week 72
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Secondary outcome [1]
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The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index at Week 16
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Assessment method [1]
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Mean Percentage Change in Psoriasis Scalp Severity Index Score From Baseline to Week 16.
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Assessment method [2]
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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.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 75 at Week 16
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Assessment method [3]
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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.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 100 at Week 16
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Assessment method [4]
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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.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Mean Percentage Change in Scalp Surface Area (SSA) Involvement From Baseline to Week 16
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Assessment method [5]
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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Time to 75% Reduction in Psoriasis Scalp Severity Index During 16-week Placebo-controlled Treatment Period.
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Assessment method [6]
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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.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Time to Investigator Global Assessment Mod 2011 (Scalp ) Response During the 16-week Placebo-controlled Treatment Period.
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Assessment method [7]
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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.
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Timepoint [7]
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Week 16
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Secondary outcome [8]
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Proportion of Subjects Achieving a 4-point Reduction in Itch Numeric Rating Scale Score From Baseline to Week 16
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Assessment method [8]
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Timepoint [8]
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Week 16
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Secondary outcome [9]
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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
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Assessment method [9]
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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.
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Timepoint [9]
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Week 16
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Secondary outcome [10]
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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
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Assessment method [10]
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Timepoint [10]
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Week 16
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Secondary outcome [11]
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Mean Percentage Change in Total Body Surface Area (BSA) Involvement From Baseline to Week 16
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Assessment method [11]
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Timepoint [11]
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Week 16
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Secondary outcome [12]
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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.
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Assessment method [12]
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Timepoint [12]
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Week 16
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Secondary outcome [13]
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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
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Assessment method [13]
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Timepoint [13]
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Week 16
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Secondary outcome [14]
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The Proportion of Subjects With IGA Mod 2011 (Scalp) Score of "Clear" and "Almost Clear" With at Least 2-point Reduction From Baseline
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Assessment method [14]
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Timepoint [14]
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Week 12
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Secondary outcome [15]
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The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index
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Assessment method [15]
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Timepoint [15]
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week 12
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Secondary outcome [16]
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Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52
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Assessment method [16]
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Timepoint [16]
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Week 52
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Secondary outcome [17]
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Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52
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Assessment method [17]
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Timepoint [17]
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Week 52
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Secondary outcome [18]
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Mean Change in Psoriasis Scalp Severity Index Score From Baseline at Week 52
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Assessment method [18]
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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.
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Timepoint [18]
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Week 52
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Secondary outcome [19]
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Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52
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Assessment method [19]
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Timepoint [19]
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Week 52
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Secondary outcome [20]
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Change From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 52
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Assessment method [20]
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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.
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Timepoint [20]
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Week 52
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Secondary outcome [21]
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Mean Change in PASI Score From Baseline at Week 52
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Assessment method [21]
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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.
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Timepoint [21]
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Week 52
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Secondary outcome [22]
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Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52
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Assessment method [22]
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Timepoint [22]
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Week 52
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Eligibility
Key inclusion criteria
1. Subjects should be 18 years or older at the time of signing the informed consent
during the Screening visit.
2. Subjects with a clinical diagnosis of chronic plaque psoriasis of at least 6 months
(as determined by-subject interview and confirmation of diagnosis through physical
examination by Investigator).
3. Subjects must have moderate to severe plaque psoriasis of the scalp at Screening and
at Baseline, defined by:
- Scalp Investigator Global Assessment (IGA) of =3
- Psoriasis Scalp Severity Index (PSSI) score of =12
- =30% or scalp surface area affected.
4. Subject must have moderate to severe plaque psoriasis at Screening and Baseline
defined by
- Physician Global Assessment for Skin (PGA-S) of at least moderate severity (score
of =3 on a 5-pointer scale)
- PASI score of =12
- Body Surface Area (BSA) involvement of >10%
5. Subjects must be considered candidates for systemic therapy, meaning scalp psoriasis
inadequately controlled by topical treatments (corticosteroids), and/or phototherapy,
and/or previous systemic therapy.
6. Subjects has a negative evaluation for tuberculosis (TB) within 4 weeks before
initiating study treatment, defined as a negative QuantiFERON® test. Subjects with a
positive or 2 successive indeterminate. QuantiFERON® tests are allowed if they have
all of the following:
- No history of active TB or symptoms of TB.
- A posterior-anterior chest radiogram (with associated report available at study
center) performed within 3 months of Screening with no evidence of active TB (or
of any other pulmonary infectious diseases).
- If prior latent TB infection (LTBI), must have history of adequate prophylaxis
(per local standard of care).
- If presence of LTBI is established, then treatment according to local country
guidelines must have been followed for 4 weeks prior to inclusion in the study.
A maximum of 2 QuantiFERON® tests are allowed. A re-test is only permitted if the
first is indeterminate; the result of the second test will then be used.
7. Subjects are unlikely to conceive, as indicated by at least one "Yes" answer to the
following questions:
- Subject is a male.
- Subject is a female and agrees to abstain from heterosexual activity OR use a
highly effective method of contraception as per Appendix 7.
- Male subjects with female partners of childbearing potential who are not using
birth control as described above must use a barrier method of contraception (eg,
condom) if not surgically sterile (ie, vasectomy).
- Subject is a surgically sterilized female or is documented to be postmenopausal.
For contraceptive guidance see Appendix 7.
8. For women of childbearing potential, a negative serum pregnancy test at Screening and
a negative urine pregnancy test within 24 hours prior to Day 1 and on subsequent
visits at which study treatment doses are scheduled.
9. Subjects must have results of a physical examination within normal limits or
clinically acceptable limits to the Investigator prior to Day 1. The Investigator is
encouraged to consult with the Medical Monitor (or appropriate designee) if there are
questions regarding the significance of any out-of-range values.
10. Subjects must be capable of giving signed informed consent as described in Appendix 2,
which includes compliance with the requirements and restrictions listed in the ICF and
in this protocol.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subjects who have laboratory abnormalities at Screening including any of the
following:
- Alanine aminotransferase or aspartate aminotransferase =2.5 × the upper limit of
normal
- Creatinine =2 × the upper limit of normal
- Serum direct bilirubin =1.5 mg/dL
- White blood cell count <3.0×103/µL
- Any other laboratory abnormality, which, in the opinion of the Investigator, will
prevent the subject from completing the study or will interfere with the
interpretation of the study results.
2. Subjects who have predominantly non-plaque forms of psoriasis specifically
erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or
medication-exacerbated psoriasis, or new-onset guttate psoriasis.
3. Women of childbearing potential who are pregnant, intend to become pregnant (within 6
months of completing the study), or are lactating.
4. Subjects with any infection or history of recurrent infection requiring treatment with
systemic antibiotics within 2 weeks prior to Screening, or severe infection (eg,
pneumonia, cellulitis, bone or joint infections) requiring hospitalization or
treatment with intravenous (IV) antibiotics within 6 weeks prior to Screening.
5. Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway
inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
• Prior use of TNF-alpha inhibitors with a wash-out period of 12 weeks would be
allowed. However, the number of subjects with prior use of TNF-alpha inhibitors would
be capped at 40% and the analysis will be stratified based on prior use of these
biologics.
6. Subjects with a positive human immunodeficiency virus test result, hepatitis B surface
antigen, or hepatitis C virus test result.
7. Subjects with a prior malignancy or concurrent malignancy (excluding successfully
treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous
cell carcinoma of skin with no evidence of recurrence within 5 years or carcinoma in
situ of the cervix that has been adequately treated).
8. Subjects who have received live viral or bacterial vaccination within 4-weeks prior to
Baseline or who intend to receive live viral or bacterial vaccination during the
study.
9. Subjects who are currently participating in another interventional clinical study or
has participated in an interventional clinical study within 5-half-lives (of the drug)
to wash-out prior to randomization (Subjects participating in observational studies or
non-interventional registry studies may be included in the study).
10. Subjects or a family member is among the personnel of the study center or
Sponsor/designee staff directly involved with this study.
11. Subjects who have any concomitant medical condition which in the opinion of the
Investigator could affect the study outcome or present an unacceptable risk.
12. Subjects who were hospitalized due to an acute cardiovascular event (such as
myocardial infarction, cerebrovascular accident, cardiovascular illness [eg, angina
pectoris], or cardiovascular surgery [such as coronary artery bypass grafting]) within
6 months before Screening.
13. Subjects who, in the opinion of the Investigator, will not be a reliable participant
in the study and those who can confound the results of the study.
14. Subjects who have a history of alcohol or drug abuse in the previous year.
15. Subjects who have high risk of suicidality at the Screening assessment based on
Investigator's judgment or, if appropriate, as indicated by a response of "yes" within
the last 12 months to Questions 4 or 5 in the suicidal ideation section, or any
positive response in the behavioral section of the Columbia-Suicide Severity Rating
Scale
16. Subjects with any other clinically significant laboratory abnormality, which, in the
opinion of the Investigator, will prevent the subject from completing the study or
will interfere with the interpretation of the study results.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/02/2022
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Sample size
Target
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Accrual to date
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Final
231
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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SPARC Site 23 - Kogarah
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Recruitment hospital [2]
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SPARC Site 27 - Kogarah
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Recruitment hospital [3]
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SPARC Site 26 - Woolloongabba
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Recruitment hospital [4]
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SPARC Site 25 - Carlton
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Recruitment hospital [5]
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SPARC Site 24 - East Melbourne
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Recruitment hospital [6]
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SPARC Site 22 - Fremantle
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3053 - Carlton
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment postcode(s) [5]
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6160 - Fremantle
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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United States of America
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State/province [3]
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New Jersey
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Country [4]
0
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United States of America
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State/province [4]
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New York
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Country [5]
0
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United States of America
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State/province [5]
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0
Ohio
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Country [6]
0
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United States of America
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State/province [6]
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Oregon
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Country [7]
0
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United States of America
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State/province [7]
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Rhode Island
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Country [8]
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United States of America
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State/province [8]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sun Pharmaceutical Industries Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03897088
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03897088
Download to PDF