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A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis

An Open-Label, Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Moderate to Severe Plaque Psoriasis

NCT03718299•Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

Summary

This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week 16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks, excluding a screening period.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects are non-immunocompromised males or females 18 years of age or older.
•2. Subjects have ≥3% total body surface area plaque psoriasis.
•3. Subjects are candidates for phototherapy or systemic therapy.
•4. Subject must be diagnosed at least 6 months prior to entering the study.
•5. Females must be surgically sterile, postmenopausal for \>5 years, or using a highly effective form of birth control (\<1% failure rate), for at least 30 days prior to test article exposure, with a negative serum pregnancy test.

Exclusion Criteria

•1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
•2. Subject is younger than 18 years of age.
•3. Subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice.
•4. Subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator.
•5. Subject is currently enrolled in an investigational drug or device study.

Locations (2)

Therapeutics Clinical Research

San Diego, California, United States

Site 02

Grandville, Michigan, United States

Key Dates

Start Date

July 16, 2019

Primary Completion Date

November 2, 2021

Completion Date

November 5, 2021

Last Updated

February 23, 2023

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

Injections of tildrakizumab

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments