Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Keywords

Psoriasis Injections of tildrakizumab tildrakizumab 100 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  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 within 7 days before the first dose of test article.

You CAN'T join if...

  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

  • Site 01 not yet accepting patients
    San Francisco California 94118 United States
  • Site 02 not yet accepting patients
    Holland Michigan 49424 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Sun Pharma Global FZE
ID
NCT03718299
Phase
Phase 4
Study Type
Interventional
Last Updated