Taltz in Combination With Enstilar for Psoriasis

Study Overview
=================
Brief Summary
-----------------
Enstilar in combination with Taltz for plaque psoriasis.

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%.

Official Title
-----------------
Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Enstilar


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enstilar<br>Enstilar foam | Drug: Enstilar<br>* topical Enstilar foam<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Surface Area 0 or 1 | Body surface area where 1 palm is equivalent to 1%. Endpoint will evaluate number of patiens who achieve body surface are 0 or 1. | 4 weeks |