A Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Psoriasis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psoriasis |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | June 2019 |
| End Date: | November 2020 |
| Contact: | Anna Houlihan |
| Email: | anna.houlihan@sunpharma.com |
| Phone: | (914)760-8796 |
An Open-Label, Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Moderate to Severe Plaque Psoriasis
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.
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.
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 within 7 days before the first
dose of test article.
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.
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