Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
Placebo SC injection at Day 1 and Week 4
Proportion of subjects with modified sPGA-G score of clear (0) or almost clear (1) with at-least a 2-point reduction from baseline
sPGA-G scale is a 6-point numerical scale that ranges from 0 (clear) to 5 (very severe)
Time frame: Week 16
Proportion of subjects, with a baseline score of ≥ 4, who achieve at-least 4-point improvement in weekly average genital psoriasis itch numerical rating scale [GPI-NRS] within the GPSS for subjects
The GPI-NRS is a self-reported measure where participants will assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.
Time frame: Week 16
Mean change from baseline in the affected Body Surface Area (BSA)
The BSA will be measured using the palm method where the palm of the subject's hand (including the palmar aspect of the fingers) represents 1 % of the BSA. The affected areas are then calculated by their size compared to the subject's palm.
Time frame: Week 16
Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores
The GPSS contains eight items regarding genital psoriasis symptoms. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents ''no symptom'' and 10 represents ''worst symptom imaginable". Each of the eight items are scored separately; in addition, a total score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms) is reported.
Time frame: Week 16
Proportion of subjects with psoriasis area and severity index [PASI] 75 response
The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
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Medical Dermatology Specialists
Phoenix, Arizona, United States
Smary Cures Clinical Research
Anaheim, California, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, United States
Center for Dermatology Clinical Research, Inc
Fremont, California, United States
Dermatology Research Associates
Los Angeles, California, United States
LA Universal Research Center Inc, Suite 1
Los Angeles, California, United States
Amicis Research Center
Northridge, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Dermatology Institute and Skin Care Center, Inc. DBA Clinical Science Institute
Santa Monica, California, United States
...and 52 more locations
Time frame: Week 16
Proportion of subjects with PASI 90 response
The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Time frame: Week 16
Proportion of subjects with PASI 100 response, in subjects with BSA <10%
The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis).
Time frame: Week 16