Psoriatic Immune Response to Tildrakizumab

NCT ID: NCT05390515

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tildrakizumab treatment

Biological/vaccine: tildrakizumab

Group Type EXPERIMENTAL

Tildrakizumab Prefilled Syringe

Intervention Type DRUG

IL-23 inhibitor

Interventions

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Tildrakizumab Prefilled Syringe

IL-23 inhibitor

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Raymond Cho, MD, PhD

Role: CONTACT

415-575-0524

Facility Contacts

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Raymond Cho, MD, PhD

Role: primary

Other Identifiers

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22-36503

Identifier Type: -

Identifier Source: org_study_id

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