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Long-Term Treatment Effect With Tildrakizumab in Participants With Plaque Psoriasis

NCT ID: NCT04339595

Last Updated: 2021-12-08

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-29

Study Completion Date

2020-07-31

Brief Summary

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The purpose of this study is to evaluate the psoriasis disease control over time in participants who had received Tildrakizumab for at least the last 5 years and have discontinued it and to describe blood and skin inflammatory biomarkers and its correlation disease relapse.

Detailed Description

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Conditions

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Plaque Psoriasis

Keywords

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Human Antibody Interleukin (IL) -23p19 Tildrakizumab Moderate-To-Severe Plaque Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tildrakizumab

Group Type EXPERIMENTAL

Tildrakizumab

Intervention Type BIOLOGICAL

Participants who have participated and completed the long-term extension phase of the reSURFACE 2 study (NCT01729754) and 12 weeks after the last Tildrakizumab dose will be included in the present study. Participants will not receive any study medication during the present study. Participants will remain in the study for 96 weeks or until they initiate any systemic therapy for psoriasis (including phototherapy), whichever occurs first.

Interventions

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Tildrakizumab

Participants who have participated and completed the long-term extension phase of the reSURFACE 2 study (NCT01729754) and 12 weeks after the last Tildrakizumab dose will be included in the present study. Participants will not receive any study medication during the present study. Participants will remain in the study for 96 weeks or until they initiate any systemic therapy for psoriasis (including phototherapy), whichever occurs first.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants provide signed written informed consent prior to perform any study-related activity
* Participants has completed the long-term extension of the reSURFACE 2 study

Exclusion Criteria

* Participants unable to comply with the requirements of the study
* Participants who in the opinion of the investigator should not participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almirall, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Almirall, SAS

Locations

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Site 0003

Lodz, , Poland

Site Status

Site 0001

Wroclaw, , Poland

Site Status

Site 0002

Wroclaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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2019-003218-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M-14745-44

Identifier Type: -

Identifier Source: org_study_id