Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587194
• Other study ID #: AP-CL-PSOR-PI-13156
• Status: Completed
• Phase: Phase 4
• Start date: July 23, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: March 2024
• Source: Psoriasis Treatment Center of Central New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Add-on Enstilar to Otezla therapy.

Description:

50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 16 weeks with add-on Enstilar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 cyclosporine).

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Otezla
Otezla 30mg BID

Locations

Country	Name	City	State
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Psoriasis Treatment Center of Central New Jersey	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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