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

NCT ID: NCT03897075

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2025-01-30

Brief Summary

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

Conditions

Chronic Plaque Psoriasis; Moderate to Severe Nail Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A

Group Type: EXPERIMENTAL

Tildrakizumab

Intervention Type: DRUG

PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

Arm B

Group Type: PLACEBO_COMPARATOR

Tildrakizumab

Intervention Type: DRUG

PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

Placebo

Intervention Type: DRUG

PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

Interventions

Tildrakizumab

PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

Intervention Type: DRUG

Placebo

PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

California Dermatology & CRI (Site 18)

Encinitas, California, United States

First OC Dermatology (Site 07)

Fountain Valley, California, United States

Dermatology Research Associates (Site 09)

Los Angeles, California, United States

Clinical Science Institute (Site 14)

Santa Monica, California, United States

Florida Academic Centers Research and Education, LLC (Site 21)

Coral Gables, Florida, United States

Renstar Medical Research (Site 23)

Ocala, Florida, United States

Forest Hills Dermatology Group (Site 04)

Forest Hills, New York, United States

Clinical Partners, LLC (Site 08)

Johnston, Rhode Island, United States

Center for Clinical Studies Cypress (Site 17)

Cypress, Texas, United States

Center for Clinical Studies (Site 11)

Houston, Texas, United States

Progressive Clinical Research (Site 27)

San Antonio, Texas, United States

Premier Dermatology (Site 47)

Kogarah, New South Wales, Australia

St George Dermatology & Skin Cancer Centre (Site 45)

Kogarah, New South Wales, Australia

Veracity Clinical Research/ Specialist Connect(Site 44)

Woolloongabba, QSLD, Australia

North Eastern Health Specialists (Site 46)

Campbelltown, South Australia, Australia

Skin Health Institute Inc. (Site 43)

Carlton, Victoria, Australia

Fremantle Dermatology (Site 40)

Fremantle, WAUS, Australia

Countries

United States; Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TILD-18-19

Identifier Type: -

Identifier Source: org_study_id