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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Plaque Psoriasis, Moderate to Severe Nail Psoriasis

In brief

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

Key facts

Study ID

NCT03897075

Run by

Sun Pharmaceutical Industries Limited

People needed

99

Starts

2021-05-13

Expected to finish

2025-01-30

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• California Dermatology & CRI (Site 18) — Encinitas, California, United States
• First OC Dermatology (Site 07) — Fountain Valley, California, United States
• 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
• Progressive Clinical Research (Site 27) — San Antonio, Texas, United States
• Premier Dermatology (Site 47) — Kogarah, New South Wales, Australia
• St George Dermatology & Skin Cancer Centre (Site 45) — Kogarah, New South Wales, Australia
• Veracity Clinical Research/ Specialist Connect(Site 44) — Woolloongabba, QSLD, Australia
• North Eastern Health Specialists (Site 46) — Campbelltown, South Australia, Australia
• Skin Health Institute Inc. (Site 43) — Carlton, Victoria, Australia
• Fremantle Dermatology (Site 40) — Fremantle, WAUS, Australia

Full record on ClinicalTrials.gov

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