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Immune Infiltrate Analysis of Psoriasis Skin During Therapy With Anti-interleukin 23 (IL-23)

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Psoriasis

Treatments

Procedure: skin biopsy

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

Psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques.

Psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development.

Although interleukin-23 blockade has been shown to be highly effective in the treatment of psoriasis, relapses have occurred during therapy.

Our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one psoriatic lesion in patients affected by moderate- severe psoriasis treated with an anti-IL-23 biologic drug. The immune infiltrate of resistant or relapsed plaques during anti-IL-23 therapy will be analysed from skin biopsies.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • moderate-severe psoriasis PASI>10
  • anti IL 23 biologic therapy for at least 6 months (for the group under treatment)
  • during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment)
  • patients able to express informed consent

Exclusion criteria

  • patients unable to express informed consent
  • patients with complete response to anti IL23, without resistant plaques or disease flare-ups

Trial design

20 participants in 2 patient groups

Sperimental
Description:
Patients affected by moderate-severe psoriasis treated with anti IL-23 therapy for at least 6 months, according to label dose.
Treatment:
Procedure: skin biopsy
No Sperimental
Description:
Patients affected by moderate-severe psoriasis that have not been already treated
Treatment:
Procedure: skin biopsy

Trial contacts and locations

1

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Central trial contact

Ketty Peris, Prof

Data sourced from clinicaltrials.gov

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