Clinical Trials/NCT03897088

NCT03897088

Completed

Phase 3

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

Sun Pharmaceutical Industries Limited25 sites in 2 countries231 target enrollmentMarch 29, 2019

ConditionsScalp Psoriasis

DrugsPART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Scalp Psoriasis
Sponsor: Sun Pharmaceutical Industries Limited
Enrollment: 231
Locations: 25
Primary Endpoint: 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
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 29, 2019

End Date

February 17, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Pharmaceutical Industries Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects should be 18 years or older at the time of signing the informed consent during the Screening visit.
•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).
•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.
•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%

Exclusion Criteria

•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.
•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.
•Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the study), or are lactating.
•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.
•Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.

Outcomes

Primary Outcomes

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 Melanoma Skin Cancer.

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 Major Adverse Cardiovascular Events

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

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

Time Frame: Week 72

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.

The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).

Time Frame: Week 72

Secondary Outcomes

Mean Percentage Change in Scalp Surface Area (SSA) Involvement From Baseline to Week 16(Week 16)
The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index at Week 16(Week 16)
Change in Investigator Global Assessment Mod 2011 (Scalp) From Baseline at Week 52(Week 52)
Mean Change in Psoriasis Scalp Severity Index Score From Baseline at Week 52(Week 52)
Mean Percentage Change in Psoriasis Scalp Severity Index Score From Baseline to Week 16.(Week 16)
The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 75 at Week 16(Week 16)
Time to 75% Reduction in Psoriasis Scalp Severity Index During 16-week Placebo-controlled Treatment Period.(Week 16)
Time to Investigator Global Assessment Mod 2011 (Scalp ) Response During the 16-week Placebo-controlled Treatment Period.(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(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(Week 16)
The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 100 at Week 16(Week 16)
Proportion of Subjects Achieving a 4-point Reduction in Itch Numeric Rating Scale Score From Baseline to Week 16(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(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.(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(Week 12)
The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index(week 12)
Change in IGA Mod 2011 (Whole-body) From Baseline at Week 52(Week 52)
Change in Physician Global Assessment for Skin (Whole Body) From Baseline at Week 52(Week 52)
Change From Baseline in Scalp Itch Numeric Rating Scale (NRS) Score at Week 52(Week 52)
Mean Percentage Change in Total Body Surface Area (BSA) Involvement From Baseline to Week 16(Week 16)
Change From Baseline in Investigator Global Assessment (Scalp Only) at Week 52(Week 52)
Mean Change in PASI Score From Baseline at Week 52(Week 52)