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Psoriasis
TILD-18-19 Enrolling

Nail and Body Psoriasis Research Trial (76 Weeks)


Treatment: Injection Age: 18 Years

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: October 02, 2022

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis

ClinicalTrials.gov ID

NCT03897075

Sponsor

Sun Pharmaceutical Industries Limited

Study Description

  • Brief Summary:

    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

  • Intervention/Treatment:

    Drug: Tildrakizumab
    Drug: Tildrakizumab
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

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.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Australia

Participating Experts

Dr. Peter Foley

Dermatologist

Dr. Kurt Gebauer

Dermatologist

Dr. Shireen Sidhu

Dermatologist

Dr. Lynda Spelman

Dermatologist

Dr. Stephen Shumack

Dermatologist

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