Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

An Open-Label Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Etanercept or Adalimumab

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

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Enstilar 0.005%-0.064% Topical Foam

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Recruiting
      • Psoriasis Treatment Center of Central New Jersey
      • Sub-Investigator: Brian Keegan, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open Label Enstilar; once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira	Drug: Enstilar 0.005%-0.064% Topical Foam; Enstilar 0.005%-0.064% Topical Foam applied once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PGA x BSA improvement	body surface area multiplied by physician global assessment	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BSA improvement	body surface area improvement	16 weeks
Dermatology Life Quality Index improvement	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.	16 weeks
Itch Numerical Rating Scale	Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).	16 weeks

Collaborators and Investigators

• Sponsor: Psoriasis Treatment Center of Central New Jersey
• Collaborators: LEO Pharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2019
• Primary Completion (ANTICIPATED): September 15, 2019
• Study Completion (ANTICIPATED): December 15, 2019

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (ACTUAL): February 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Micronutrients; Membrane Transport Modulators; Anti-Asthmatic Agents; Respiratory System Agents; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Betamethasone; Betamethasone-17,21-dipropionate; Calcipotriene; Calcitriol
• Other Study ID Numbers: PTC04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No