Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

Phase 4

Recruiting

• Conditions: Psoriasis
• Interventions: Drug: Enstilar 0.005%-0.064% Topical Foam

• Registration Number: NCT03827876
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

Brief Summary

4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10% BSA who are receiving etanercept or adalimumab for at least 24 weeks

Detailed Description

30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface area 2-10% and physician global assessment greater than or equal to 2 will receive Enstilar® once daily for 4 weeks followed by QOD for 12 weeks.

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-16
• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Study First Posted: 2019-02-04
• Last Update Posted: 2019-02-04
• Primary Completion: 2019-09-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female adult ≥ 18 years of age;
• Diagnosis of chronic plaque-type
• Patient with 2-10% BSA
• Physician Global Assessment of 2 or greater
• Patient has been treated with etanercept or adalimumab for a minimum of 24 weeks

Exclusion Criteria

• ˂2 or >10% BSA
• PGA <2
• Patient not receiving etanercept or adalimumab, or receiving etanercept or adalimumab <24weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Enstilar	Enstilar 0.005%-0.064% Topical Foam	once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira

Primary Outcome Measures

Name	Time	Method
PGA x BSA improvement	16 weeks	body surface area multiplied by physician global assessment

Secondary Outcome Measures

Name	Time	Method
Itch Numerical Rating Scale	16 weeks	Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).
BSA improvement	16 weeks	body surface area improvement
Dermatology Life Quality Index improvement	16 weeks	patient reported outcome improvements of DLQI (Dermatology Life Quality Index). Calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.

Trial Locations

Locations (1)

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