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:

210

Study ID:

NCT03897075

Recruitment Status:

Recruiting

Sponsor:

Sun Pharmaceutical Industries Limited

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There are 27 Locations for this study

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UAB of Birmingham (Site 26)
Birmingham Alabama, 35233, United States More Info
California Dermatology & CRI (Site 13)
Encinitas California, 92007, United States More Info
First OC Dermatology (Site 09)
Fountain Valley California, 92708, United States More Info
Avance Trials (Site 14)
Laguna Niguel California, 92677, United States More Info
Dermatology Research Associates (Site 10)
Los Angeles California, 90045, United States More Info
Clinical Science Institute (Site 05)
Santa Monica California, 90404, United States More Info
Florida Academic Centers Research and Education, LLC (Site 07)
Coral Gables Florida, 33134, United States More Info
Renstar Medical Research (Site 23)
Ocala Florida, 34470, United States More Info
Clinical Trials Management,LLC (Site 12)
Metairie Louisiana, 70006, United States More Info
ActivMed Practices & Research, Inc (Site 28)
Beverly Massachusetts, 01915, United States More Info
Revival Research Institute (Site 24)
Troy Michigan, 48084, United States More Info
Allcutis Research, LLC (Site 27)
Portsmouth New Hampshire, 03801, United States More Info
Forest Hills Dermatology Group (Site 01)
Forest Hills New York, 11375, United States More Info
Haber Dermatology, Inc. (Site 08)
Beachwood Ohio, 44122, United States More Info
Apex Clinical Research Center /Apex Dermatology (Site 25)
Mayfield Heights Ohio, 44124, United States More Info
Oregon Dermatology and Research Center (Site 11)
Portland Oregon, 97210, United States More Info
Clinical Partners, LLC (Site 03)
Johnston Rhode Island, 02919, United States More Info
Center for Clinical Studies Cypress (Site 06)
Cypress Texas, 77433, United States More Info
Center for Clinical Studies (Site 04)
Houston Texas, 77004, United States More Info
Progressive Clinical Research (Site 15)
San Antonio Texas, 78213, United States More Info
Center for Clinical Studies, LTD.LLP (Site 02)
Webster Texas, 77598, United States More Info
Premier Dermatology (SIte 20)
Kogarah New South Wales, 2217, Australia More Info
St George Dermatology & Skin Cancer Centre (Site 22)
Kogarah New South Wales, 2217, Australia More Info
Veracity Clinical Research/ Specialist Connect(Site 19)
Woolloongabba QSLD, 4102, Australia More Info
North Eastern Health Specialists (Site 21)
Campbelltown South Australia, 5073, Australia More Info
Skin Health Institute Inc. (Site 18)
Carlton Victoria, 3053, Australia More Info
Sinclair Dermatology (Site 17)
East Melbourne Victoria, 3002, Australia More Info
Fremantle Dermatology (Site 16)
Fremantle WAUS, 6160, Australia More Info

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

210

Study ID:

NCT03897075

Recruitment Status:

Recruiting

Sponsor:


Sun Pharmaceutical Industries Limited

How clear is this clinincal trial information?

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