Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

NCT ID: NCT03587194

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2019-07-01

Brief Summary

Add-on Enstilar to Otezla therapy.

Detailed Description

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

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Otezla Enstilar

Otezla 30mg BID Enstilar QD

Group Type: EXPERIMENTAL

Otezla

Intervention Type: DRUG

Otezla 30mg BID

Interventions

Otezla

Otezla 30mg BID

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Psoriasis Treatment Center of Central New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry Bagel

Role: PRINCIPAL_INVESTIGATOR

dreamacres1@aol.com

Locations

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AP-CL-PSOR-PI-13156

Identifier Type: -

Identifier Source: org_study_id