Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Study Overview
=================
Brief Summary
-----------------
Patients with moderate to severe plaque psoriasis will be treated with Otezla BID. At week 8, non responders will be discontinued, partial responders will be given add-on Enstilar QD for 4 weeks and PASI 75 responders will remain on Otezla monotherapy through week 16.

Detailed Description
-----------------
50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 8 weeks. At week 8, patients who achieved between PASI 25-74 response will receive 4 weeks of Enstilar® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% in addition to continuing OTEZLA® therapy. Patients who do not meet PASI 25 at week 8 will be discontinued from the study. At week 12 (after 4 consecutive weeks of Enstilar® add on therapy), Enstilar® will be discontinued and these patients will continue Otezla® as monotherapy through week 16. Patients who achieve PASI 75 at week 8 will remain enrolled on Otezla® monotherapy through week 16.

Official Title
-----------------
A Single Center Study to Evaluate the Effectiveness and Safety of Add on Enstilar® in Patients Using OTEZLA® for Moderate to Severe Plaque Psoriasis

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

Intervention / Treatment
-----------------
* Drug: Otezla


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adult ≥ 18 years of age; Diagnosis of chronic plaque-type psoriasis Moderate to severe plaque type psoriasis as defined at baseline by: PGA score of 3 or greater BSA affected by plaque-type psoriasis of 10% or greater PASI ≥ 12 Able and willing to give written informed consent prior to performance of any study-related procedures Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions). Exclusion Criteria: Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis Subjects who previously used any biologic agent for psoriasis. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine). Patient used topical therapies to treat psoriasis on the hands and/or feet within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids). Patient received UVB phototherapy within 2 weeks of Baseline.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Otezla<br>Otezla BID | Drug: Otezla<br>* Otezla 30mg BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area Severity Index 75 at week 12 | Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease) | 12 weeks |