Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
99
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
California Dermatology & CRI (Site 18)
Encinitas, California, United States
First OC Dermatology (Site 07)
Fountain Valley, California, United States
The Proportion of Subjects Who Achieve at Least a 75% Improvement From Baseline in Total mNAPSI at Week 28.
Primary Efficacy Endpoint
Time frame: Week 28
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.
Time frame: 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
Time frame: Week 28
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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
...and 7 more locations