Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis.

  • STATUS
    Recruiting
  • sponsor
    Sun Pharma
Updated on 4 May 2022

Summary

This study is for adults, 18 or older with a clinical diagnosis of chronic moderate to severe plaque-type psoriasis that has been present for at least 6 months. Subjects must also have moderate to severe psoriasis of the nails at the screening and baseline visits and who are considered candidates for systemic therapy.

Description

The study duration is approximately 15 visits over 72 weeks, not including the screening period. The study drug is given by subcutaneous (injection).

Details
Condition Psoriasis and Psoriatic Disorders
Clinical Study IdentifierTX298614
SponsorSun Pharma
Last Modified on4 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years or older at the Screening visit
Subjects with a clinical diagnosis of chronic moderate to severe plaque-type psoriasis for at least 6 months with nail psoriasis
Willing to be given the study drug by injection
Willing to use contraception during the study
Meet additional study criteria to qualify

Exclusion Criteria

Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis
Prior use of TNF-alpha inhibitors with a wash-out period of 12 weeks would be allowed
Subjects with erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis
History of alcohol or substance abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study
Subjects with known history of HIV, Hepatitis B or Hepatitis C
Subjects with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails (fungal infection), which may potentially confound the evaluation of study treatment
Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the study), or are lactating
Meet additional study criteria to qualify
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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