- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827876
Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis
January 31, 2019 updated by: Psoriasis Treatment Center of Central New Jersey
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
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
|
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
Time Frame: 16 weeks
|
body surface area multiplied by physician global assessment
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BSA improvement
Time Frame: 16 weeks
|
body surface area improvement
|
16 weeks
|
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.
|
16 weeks
|
Itch Numerical Rating Scale
Time Frame: 16 weeks
|
Patient reported itch scale from 0 (no itch) to 10 (worst imaginable itch).
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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