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Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

Primary Purpose

Psoriasis

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Enstilar 0.005%-0.064% Topical Foam

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Psoriasis Treatment Center of Central New JerseyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label Enstilar

Arm Description

once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira

Outcomes

Primary Outcome Measures

PGA x BSA improvement

body surface area multiplied by physician global assessment

Secondary Outcome Measures

BSA improvement

body surface area improvement

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.

Itch Numerical Rating Scale

Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).

Full Information

NCT ID

NCT03827876

First Posted

January 29, 2019

Last Updated

January 31, 2019

Sponsor

Psoriasis Treatment Center of Central New Jersey

Collaborators

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT03827876

Brief Title

Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 16, 2019 (Actual)

Primary Completion Date

September 15, 2019 (Anticipated)

Study Completion Date

December 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Psoriasis Treatment Center of Central New Jersey

Collaborators

LEO Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

open label

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open Label Enstilar

Arm Type

Experimental

Arm Description

once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira

Intervention Type

Drug

Intervention Name(s)

Enstilar 0.005%-0.064% Topical Foam

Intervention Description

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

Primary Outcome Measure Information:

Title

PGA x BSA improvement

Description

body surface area multiplied by physician global assessment

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

BSA improvement

Description

body surface area improvement

Time Frame

16 weeks

Title

Dermatology Life Quality Index improvement

Description

Time Frame

16 weeks

Title

Itch Numerical Rating Scale

Description

Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jerry Bagel, MD

Phone

6094434500

dreamacres1@aol.com

First Name & Middle Initial & Last Name or Official Title & Degree

Elise Nelson

Phone

6094434500

enelson@windsordermatology.com

Facility Information:

Facility Name

Psoriasis Treatment Center of Central New Jersey

City

East Windsor

State/Province

New Jersey

ZIP/Postal Code

08520

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elise Nelson

Phone

609-443-4500

Ext

1402

enelson@windsordermatology.com

First Name & Middle Initial & Last Name & Degree

Jerry Bagel, MD

First Name & Middle Initial & Last Name & Degree

Brian Keegan, MD, PhD

First Name & Middle Initial & Last Name & Degree

David Nieves, MD

First Name & Middle Initial & Last Name & Degree

Alexa Hetzel, PA-C

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

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