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

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

Official Title
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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

Conditions
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Chronic Plaque Psoriasis, Moderate to Severe Nail Psoriasis

Intervention / Treatment
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* Drug: Tildrakizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who achieve at least a 75% improvement from baseline in totalmNAPSI at Week 28. | Primary Efficacy Endpoint | Week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |