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

Phase 3

Active, not recruiting

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

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who achieve at least a 75% improvement from baseline in totalmNAPSI at Week 28.	Week 28	Primary Efficacy Endpoint

Secondary Outcome Measures

Name	Time	Method
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

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