Taltz in Combination With Enstilar for Psoriasis
Purpose
Enstilar in combination with Taltz for plaque psoriasis.
Condition
- Psoriasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female adult ≥ 18 years of age; - Diagnosis of chronic plaque-type - Body Surface Area between 3%-8%. - Patient has been treated with Taltz for a minimum of 24 weeks - Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide. - Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination - Able and willing to give written informed consent prior to performance of any study-related procedures.
Exclusion Criteria
- ˂3% or >8% BSA - Patient not receiving Taltz, or receiving Taltz <24 weeks - Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study. - Pregnant or breast feeding, or considering becoming pregnant during the study. - Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). - Use of oral systemic medications for the treatment of psoriasis within 4 weeks. - Patient used other topical therapies to treat within 2 weeks of the Baseline Visit. - Patient received UVB phototherapy within 2 weeks of Baseline. - Patient received PUVA phototherapy within 4 weeks of Baseline. - Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- open-label
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Enstilar |
Enstilar foam |
|
Recruiting Locations
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey 08520
East Windsor, New Jersey 08520
More Details
- NCT ID
- NCT04372277
- Status
- Recruiting
- Sponsor
- Psoriasis Treatment Center of Central New Jersey
Detailed Description
A single center study of 25 subjects to assess the addition of Enstilar Foam in patients receiving Taltz for ≥ 24 weeks with BSA between 3% and 8%.