NCT05390515

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

May 20, 2022

Last Update Submit

August 25, 2023

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline, 3 months

Study Arms (1)

Tildrakizumab treatment

EXPERIMENTAL

Biological/vaccine: tildrakizumab

Drug: Tildrakizumab Prefilled Syringe

Interventions

Tildrakizumab Prefilled SyringeDRUG

IL-23 inhibitor

Tildrakizumab treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

RECRUITING

Study Officials

  • Raymond Cho, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Cho, MD, PhD

CONTACT

415-575-0524rashes@ucsf.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)