Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

NCT ID: NCT03827876

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-16

Study Completion Date

2019-12-15

Brief Summary

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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

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Enstilar

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

Group Type EXPERIMENTAL

Enstilar 0.005%-0.064% Topical Foam

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role collaborator

Psoriasis Treatment Center of Central New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jerry Bagel, MD

Role: CONTACT

6094434500

Elise Nelson

Role: CONTACT

6094434500

Facility Contacts

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Elise Nelson

Role: primary

609-443-4500 ext. 1402

Other Identifiers

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PTC04

Identifier Type: -

Identifier Source: org_study_id

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