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Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03827876
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Enstilar 0.005%-0.064% Topical Foam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open label
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




Primary Outcome Measures :
  1. PGA x BSA improvement [ Time Frame: 16 weeks ]
    body surface area multiplied by physician global assessment


Secondary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827876


Contacts
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Contact: Jerry Bagel, MD 6094434500 dreamacres1@aol.com
Contact: Elise Nelson 6094434500 enelson@windsordermatology.com

Locations
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United States, New Jersey
Psoriasis Treatment Center of Central New Jersey Recruiting
East Windsor, New Jersey, United States, 08520
Contact: Elise Nelson    609-443-4500 ext 1402    enelson@windsordermatology.com   
Principal Investigator: Jerry Bagel, MD         
Sub-Investigator: Brian Keegan, MD, PhD         
Sub-Investigator: David Nieves, MD         
Sub-Investigator: Alexa Hetzel, PA-C         
Sponsors and Collaborators
Psoriasis Treatment Center of Central New Jersey
LEO Pharma

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Responsible Party: Psoriasis Treatment Center of Central New Jersey
ClinicalTrials.gov Identifier: NCT03827876     History of Changes
Other Study ID Numbers: PTC04
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Etanercept
Betamethasone
Betamethasone-17,21-dipropionate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action