Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - Any
Start Date:July 23, 2018
End Date:September 1, 2019
Contact:Jerry Bagel, MD

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

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.

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.

Inclusion Criteria:

1. Male or female adult ≥ 18 years of age;

2. Diagnosis of chronic plaque-type psoriasis

3. 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

4. Able and willing to give written informed consent prior to performance of any
study-related procedures

5. 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:

1. 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.

2. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or
guttate psoriasis) or drug induced psoriasis

3. Subjects who previously used any biologic agent for psoriasis.

4. Use of oral systemic medications for the treatment of psoriasis within 4 weeks
(includes, but not limited to, oral corticosteroids, methotrexate, acitretin and

5. 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).

6. Patient received UVB phototherapy within 2 weeks of Baseline.
We found this trial at
59 One Mile Road
East Windsor, New Jersey 08520
Principal Investigator: Jerry Bagel, MD
East Windsor, NJ
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