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Recruiting

NCT Number: NCT05390515

Psoriatic Immune Response to Tildrakizumab

This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.

Recruiting

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94115, United States

Location status: Recruiting

Location contact

Raymond Cho, MD, PhD

CONTACT

About this study

This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Patients with moderate-severe psoriasis or > 5% body surface area affected.

Exclusion criteria

  • taking systemic immunosuppressives in the last 4 weeks
  • pregnancy
  • severe immunodeficiency (either from genetic or infectious causes).
  • tuberculosis or other active serious infection
  • active systemic malignancy.
  • breast-feeding
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Treatment and study plan

Tildrakizumab Prefilled Syringe

Drug

IL-23 inhibitor

Primary outcomes

  1. Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment

    Time frame: Baseline, 3 months

    Change in severity and extent of psoriasis (calculated by Psoriasis Area and Severity Index (PASI) score); scale range of 0 to 72, 72 being maximal disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond Cho, MD, PhD

CONTACT

[email protected]

415-575-0524

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Sun Pharmaceutical Industries Limited

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
May 25, 2022
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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