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

NCT03897075 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: TILD-18-19
• Study Type: interventional
• Target: 99
• Locations: 2 countries
• Sites: 17

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Outcomes (8)

• 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 the Regulatory Definition of a Serious Adverse Event, or Any Infection Requiring Intravenous Antibiotics.

  Week 52

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

  Week 52

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Tildrakizumab

Arm B

PLACEBO COMPARATOR

Drug: Tildrakizumab; Drug: Placebo

Interventions

Tildrakizumab DRUG

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

Arm A; Arm B

Placebo DRUG

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

Arm B

Eligibility Criteria

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

You may qualify if:

• Subjects are eligible to be included in the study only if all of the following criteria apply:
• 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).
• Subjects must have moderate to severe nail psoriasis at Screening and Baseline, defined by:
• mNAPSI score of ≥20.
• ViSENPsO ≥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
• Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.

You may not qualify if:

• Subjects are excluded from the study if any of the following criteria apply:
• 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.
• 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.
• 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.
• Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
• Subjects with known history of allergy or hypersensitivity to any of the inactive ingredients of the Tildrakizumab or placebo formulations.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (17)

California Dermatology & CRI (Site 18)

Encinitas, California, 92007, United States

Location

First OC Dermatology (Site 07)

Fountain Valley, California, 92708, United States

Location

Dermatology Research Associates (Site 09)

Los Angeles, California, 90045, United States

Location

Clinical Science Institute (Site 14)

Santa Monica, California, 90404, United States

Location

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

Coral Gables, Florida, 33134, United States

Location

Renstar Medical Research (Site 23)

Ocala, Florida, 34470, United States

Location

Forest Hills Dermatology Group (Site 04)

Forest Hills, New York, 11375, United States

Location

Clinical Partners, LLC (Site 08)

Johnston, Rhode Island, 02919, United States

Location

Center for Clinical Studies Cypress (Site 17)

Cypress, Texas, 77433, United States

Location

Center for Clinical Studies (Site 11)

Houston, Texas, 77004, United States

Location

Progressive Clinical Research (Site 27)

San Antonio, Texas, 78213, United States

Location

Premier Dermatology (Site 47)

Kogarah, New South Wales, 2217, Australia

Location

St George Dermatology & Skin Cancer Centre (Site 45)

Kogarah, New South Wales, 2217, Australia

Location

Veracity Clinical Research/ Specialist Connect(Site 44)

Woolloongabba, QSLD, 4102, Australia

Location

North Eastern Health Specialists (Site 46)

Campbelltown, South Australia, 5073, Australia

Location

Skin Health Institute Inc. (Site 43)

Carlton, Victoria, 3053, Australia

Location

Fremantle Dermatology (Site 40)

Fremantle, WAUS, 6160, Australia

Location

MeSH Terms

Interventions

tildrakizumab

Results Point of Contact

• Title: Head-Regulatory Affairs
• Organization: Sun Pharmaceutical Industries Limited

Clinical.Trial@sunpharma.com

0226645

Publication Agreements

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

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: May 13, 2021
• Primary Completion: April 5, 2024
• Study Completion: January 30, 2025
• Last Updated: April 1, 2026
• Results First Posted: June 6, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); US (11)