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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03718299
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sun Pharma Global FZE
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

Other: tildrakizumab 100 mg

Interventions

Drug: - Injections of tildrakizumab

given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Therapeutics Clinical Research, San Diego, California

Status

Recruiting

Address

Therapeutics Clinical Research

San Diego, California, 92123

Site Contact

Aracelli Torres

[email protected]m

(914)760-8796

Site 02, Grandville, Michigan

Status

Recruiting

Address

Site 02

Grandville, Michigan, 49418

Site Contact

Jayme Heim NP

[email protected]

616-257-3344

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