Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03827876

Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location status: Recruiting

Location contact

Alexa Hetzel, PA-C

SUB_INVESTIGATOR

Brian Keegan, MD, PhD

SUB_INVESTIGATOR

David Nieves, MD

SUB_INVESTIGATOR

Elise Nelson

CONTACT

[email protected]

609-443-4500 ext. 1402

Jerry Bagel, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enstilar 0.005%-0.064% Topical Foam

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

Primary outcomes

  1. PGA x BSA improvement

    Time frame: 16 weeks

    body surface area multiplied by physician global assessment

Secondary outcomes

  1. BSA improvement

    Time frame: 16 weeks

    body surface area improvement

  2. Dermatology Life Quality Index improvement

    Time frame: 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.

  3. Itch Numerical Rating Scale

    Time frame: 16 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Nelson

CONTACT

[email protected]

6094434500

Jerry Bagel, MD

CONTACT

[email protected]

6094434500

Sponsors and collaborators

Lead sponsor

Psoriasis Treatment Center of Central New Jersey

Other

Collaborators

  • LEO Pharma

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2019
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.