Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis

NCT03897088 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TILD-18-20
• Study Type: interventional
• Target: 231
• Locations: 2 countries
• Sites: 25

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.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (9)

• 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

  Week 16

• The Percentage of Subjects With Incidence, Seriousness and Severity of All Adverse Events.

  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.

  Week 72

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

  Week 72

• The Percentage of Subjects With Melanoma Skin Cancer.

  Week 72

• The Percentage of Subjects With Major Adverse Cardiovascular Events

  Week 72

• The Percentage of Subjects With Study Treatment-related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc.).

  Week 72

• The Percentage of Subjects With Injection Site Reactions (eg, Pain, Erythema, Edema Etc).

  Week 72

• The Percentage of Subjects With Non-melanoma Skin Cancer

  Week 72

Secondary Outcomes (22)

• The Proportion of Subjects With at Least 90% Improvement From Baseline in the Psoriasis Scalp Severity Index at Week 16

  Week 16

• 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

• The Proportion of Subjects Achieving Psoriasis Scalp Severity Index 100 at Week 16

  Week 16

• Mean Percentage Change in Scalp Surface Area (SSA) Involvement From Baseline to Week 16

  Week 16

Other Outcomes (1)

• Change From Baseline in Dermatology Life Quality Index Score (Total and 6 Domain Scores) at Measured Time Points Through Week 52

  Week 52

Study Arms (3)

Tildrakizumab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: PART 1: Double-blind Placebo-controlled

PART 3: Observational Safety Follow-up

NO INTERVENTION

The subjects will not receive study treatment during the follow-up period

Interventions

PART 1: Double-blind Placebo-controlled DRUG

all eligible subjects will receive either tildrakizumab or placebo

Placebo; Tildrakizumab

PART 2: Double-blind Active Treatment Extension DRUG

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

Tildrakizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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.
• 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).

You may not qualify if:

• 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.
• 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.
• Subjects with a positive human immunodeficiency virus test result, hepatitis B surface antigen, or hepatitis C virus test result.
• 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).
• 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.
• 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).

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (25)

SPARC Site 18

Encinitas, California, 92024, United States

Location

SPARC Site 7

Fountain Valley, California, 92708, United States

Location

SPARC Site 3

Fremont, California, 94538, United States

Location

SPARC Site 12

Huntington Beach, California, 92647, United States

Location

SPARC Site 9

Los Angeles, California, 90045, United States

Location

SPARC Site 2

Los Angeles, California, 90057, United States

Location

SPARC Site 14

Santa Monica, California, 90404, United States

Location

SPARC Site 21

Coral Gables, Florida, 33134, United States

Location

SPARC Site 19

Margate, Florida, 33063, United States

Location

SPARC Site 5

Sweetwater, Florida, 33172, United States

Location

SPARC Site 13

East Windsor, New Jersey, 08520, United States

Location

SPARC Site 4

Forest Hills, New York, 11375, United States

Location

SPARC Site 16

New York, New York, 10003, United States

Location

SPARC Site 01

Beachwood, Ohio, 44122, United States

Location

SPARC Site 20

Portland, Oregon, 97223, United States

Location

SPARC Site 8

Johnston, Rhode Island, 02919, United States

Location

SPARC Site 17

Cypress, Texas, 77433, United States

Location

SPARC Site 11

Houston, Texas, 77004, United States

Location

SPARC Site 6

Webster, Texas, 77598, United States

Location

SPARC Site 23

Kogarah, New South Wales, 2217, Australia

Location

SPARC Site 27

Kogarah, New South Wales, 2217, Australia

Location

SPARC Site 26

Woolloongabba, Queensland, 4102, Australia

Location

SPARC Site 25

Carlton, Victoria, 3053, Australia

Location

SPARC Site 24

East Melbourne, Victoria, 3002, Australia

Location

SPARC Site 22

Fremantle, Western Australia, 6160, Australia

Location

Results Point of Contact

• Title: Head-Clinical Development
• Organization: Sun Pharmaceutical Industries Limited

clinical.trial@sunpharma.com

2266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 1, 2019
• Study Start: March 29, 2019
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: May 31, 2023
• Results First Posted: May 31, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); US (19)