Adults aged 18 years or older with chronic moderate to severe plaque-type psoriasis for at least 6 months, may qualify to participate. Individuals must have moderate to severe nail psoriasis AND moderate to severe plaque psoriasis on the body. Psoriatic involvement of 10% or more body surface area (BSA) is required in addition to nail involvement. Participants must be considered candidates for systemic therapy, meaning psoriasis is inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
Participants will receive investigational medication (active study drug) or placebo in Part 1, via subcutaneous injection. In Part 2, those who initially received placebo will be switched over to receive active study drug. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses will also be provided.
Study participation will last about 76 weeks and involve about 15 visits to the study centre.
The following information is from ClinicalTrials.gov
Last Update Posted: September 24, 2023
Sun Pharmaceutical Industries Limited
Phase 3b study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis
Condition or Disease:
Chronic Plaque Psoriasis
Ages Eligible for Study:
18 Years and older (Adult)
Sexes Eligible for Study:
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.
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%.
Subjects must be considered candidates for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
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.
Terms and Conditions – ClinicalTrials.gov
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