Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Drug: Otezla

• Registration Number: NCT03587194
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

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.

Study Timeline

• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-16
• Study Start: 2018-07-23
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2024-03
• Results First Submitted: 2024-03-18
• Results First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Results First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Otezla Enstilar	Otezla	Otezla 30mg BID Enstilar QD

Primary Outcome Measures

Name	Time	Method
Psoriasis Area Severity Index 75 at Week 12	12 weeks	Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)

Trial Locations

Locations (1)

Psoriasis Treatment Center of Central New Jersey; 🇺🇸 East Windsor, New Jersey, United States