Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis

Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis

Study Overview

• Status: Completed
• Conditions: Chronic Plaque Psoriasis; Moderate to Severe Nail Psoriasis
• Intervention / Treatment: Drug: Tildrakizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Premier Dermatology (Site 47)
    • Kogarah, New South Wales, Australia, 2217
      • St George Dermatology & Skin Cancer Centre (Site 45)
  • QSLD
    • Woolloongabba, QSLD, Australia, 4102
      • Veracity Clinical Research/ Specialist Connect(Site 44)
  • South Australia
    • Campbelltown, South Australia, Australia, 5073
      • North Eastern Health Specialists (Site 46)
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc. (Site 43)
  • WAUS
    • Fremantle, WAUS, Australia, 6160
      • Fremantle Dermatology (Site 40)
• United States
  • California
    • Encinitas, California, United States, 92007
      • California Dermatology & CRI (Site 18)
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology (Site 07)
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates (Site 09)
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute (Site 14)
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Centers Research and Education, LLC (Site 21)
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research (Site 23)
  • New York
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology Group (Site 04)
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Clinical Partners, LLC (Site 08)
  • Texas
    • Cypress, Texas, United States, 77433
      • Center for Clinical Studies Cypress (Site 17)
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies (Site 11)
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research (Site 27)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects are eligible to be included in the study only if all of the following criteria apply:

1. Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by Investigator).

2. Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by:

   • mNAPSI score of ≥20.
   • ViSENPsO ≥3

3. Subjects must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:

   • s-PGA score of at least 3.
   • Body Surface Area (BSA) involvement of ≥10%.
   • PASI ≥12
4. Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

1. 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.
2. Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment.
3. Subjects with fungal nail infection should be excluded from the study. Subjects in whom the Investigator suspects a fungal nail infection in addition to nail psoriasis should have scrapings sent for direct microscopy and fungal culture. If fungal culture or direct microscopy of nail scrapings turns out to be positive for fungal infection, the subject should be excluded from the study. At the discretion of the investigator, Periodic Acid-Schiff (PAS) staining for nail clippings could also be considered to rule of fungal infection of the nails. Direct microscopy or fungal culture are not required if fungal infection is diagnosed in PAS staining.
4. Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
5. Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A	Drug: Tildrakizumab; PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
Placebo Comparator: Arm B	Drug: Tildrakizumab; PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up; Drug: Placebo; PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Subjects Who Achieve at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28.	Primary Efficacy Endpoint	Week 28

Secondary Outcome Measures

Outcome Measure	Time Frame
The Proportion of Subjects With a Score of "0 - Normal" or "1 - Minimal Nail Psoriasis" and at Least a 2-point Decrease From Baseline at Week 28 as Measured by the ViSENPsO.	Week 28
The Proportion of Subjects With at Least 3 Point Decrease From Baseline, in Nail Pain NRS Score in Subjects With Baseline Nail Pain NRS Score of >3	Week 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Subjects With Malignancies (Excluding Carcinoma in Situ of the Cervix).	Primary Safety Endpoint	Week 52
The Percentage of Subjects With Non-melanoma Skin Cancer.	Primary Safety Endpoint	Week 52
The Percentage of Subjects With Major Adverse Cardiovascular Events.	Primary Safety Endpoint	Week 52
The Percentage of Subjects With Melanoma Skin Cancer.	Primary Safety Endpoint	Week 52
The Percentage of Subjects With Injection Site Reactions (eg. Pain, Erythema, Edema Etc)	Primary Safety Endpoint	Week 52
The Percentage of Subjects With Study Treatment Related Hypersensitivity Reactions (eg, Anaphylaxis, Urticaria, Angioedema, Etc).	Primary Safety Endpoint	Week 52
The Percentage of Subjects With Incidence, Seriousness, and Severity of All Adverse Events.	Primary Safety Endpoint. Total Number Affected by serious and non-serious adverse events from Baseline through Week 72	Week 72
The Percentage of Subjects With Severe Infections Whether or Not Reported as a Serious Event Defined as Any Infection Meeting the Regulatory Definition of a Serious Adverse Event, or Any Infection Requiring Intravenous Antibiotics.	Primary Safety Endpoint.	Week 52

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Actual): April 5, 2024
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; tildrakizumab
• Other Study ID Numbers: TILD-18-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No