Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

NCT03587194 | Completed Phase 4 Results FDA Drug

• 1 other identifier: AP-CL-PSOR-PI-13156
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Add-on Enstilar to Otezla therapy.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Otezla Enstilar

EXPERIMENTAL

Otezla 30mg BID Enstilar QD

Drug: Otezla

Interventions

Otezla DRUG

Otezla 30mg BID

Otezla Enstilar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Psoriasis Treatment Center of Central New Jersey: lead
• Celgene Corporation: collaborator

Study Sites (1)

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Ashley Reed
• Organization: Psoriasis Treatment Center of Central New Jersey

ashley.reed@schweigerderm.com

6094434500

Study Officials

• Jerry Bagel

  dreamacres1@aol.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 16, 2018
• Study Start: July 23, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)