Melanoma Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

96

Study ID:

NCT03897075

Recruitment Status:

Recruiting

Sponsor:

Sun Pharmaceutical Industries Limited

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There are 23 Locations for this study

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California Dermatology & CRI (Site 13)
Encinitas California, 92007, United States
First OC Dermatology (Site 09)
Fountain Valley California, 92708, United States
Avance Trials (Site 14)
Laguna Niguel California, 92677, United States
Dermatology Research Associates (Site 10)
Los Angeles California, 90045, United States
Clinical Science Institute (Site 05)
Santa Monica California, 90404, United States
Florida Academic Centers Research and Education, LLC (Site 07)
Coral Gables Florida, 33134, United States
Site 23
Ocala Florida, 34470, United States
Clinical Trials Management,LLC (Site 12)
Metairie Louisiana, 70006, United States
Site 24
Troy Michigan, 48084, United States
Forest Hills Dermatology Group (Site 01)
Forest Hills New York, 11375, United States
Haber Dermatology, Inc. (Site 08)
Beachwood Ohio, 44122, United States
Site 25
Mayfield Heights Ohio, 44124, United States
Oregon Dermatology and Research Center (Site 11)
Portland Oregon, 97210, United States
Clinical Partners, LLC (Site 03)
Johnston Rhode Island, 02919, United States
Center for Clinical Studies Cypress (Site 06)
Cypress Texas, 77433, United States
Center for Clinical Studies (Site 04)
Houston Texas, 77004, United States
Progressive Clinical Research (Site 15)
San Antonio Texas, 78213, United States
Center for Clinical Studies, LTD.LLP (Site 02)
Webster Texas, 77598, United States
Site 20
Kogarah New South Wales, 2217, Australia
Site 22
Kogarah New South Wales, 2217, Australia
Veracity Clinical Research/ Specialist Connect(Site 19)
Woolloongabba QSLD, 4102, Australia
North Eastern Health Specialists (Site 21)
Campbelltown South Australia, 5073, Australia
Skin Health Institute Inc. (Site 18)
Carlton Victoria, 3053, Australia
Fremantle Dermatology (Site 16)
Fremantle WAUS, 6160, Australia

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

96

Study ID:

NCT03897075

Recruitment Status:

Recruiting

Sponsor:


Sun Pharmaceutical Industries Limited

How clear is this clinincal trial information?

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