Back to resultsDuobrii in Combination With Biologics
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duobrii
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or female adult ≥ 18 years of age;
- Diagnosis of chronic plaque-type
- Psoriasis affecting 2%-10% BSA
- Patient is being treated with biologic therapy for a minimum of 24 weeks
- Able and willing to give written informed consent prior to performance of any study-related procedures
Exclusion Criteria:
- Psoriasis affecting ˂2% or >10% BSA
- Patient not receiving a biologic agent, or receiving biologic agent <24weeks
- Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.
- Has previously used DUOBRII
Sites / Locations
- Psoriasis Treatment Center of Central New JerseyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label Duobrii
Arm Description
Duobrii QD
Outcomes
Primary Outcome Measures
Body surface area improvement
body surface area determined by palm method where 1 palm is equivalent to 1%
Secondary Outcome Measures
Full Information
NCT ID
NCT04119102
First Posted
October 3, 2019
Last Updated
April 29, 2020
Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Ortho Dermatologics
1. Study Identification
Unique Protocol Identification Number
NCT04119102
Brief Title
Duobrii in Combination With Biologics
Official Title
Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Ortho Dermatologics
4. Oversight
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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks
Detailed Description
A single center, pilot study of 25 subjects to assess 12 weeks DUOBRII to patients with 2%-10% body surface area who are receiving biologic therapy for at least 24 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
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open Label Duobrii
Arm Type
Experimental
Arm Description
Duobrii QD
Intervention Type
Drug
Intervention Name(s)
Duobrii
Intervention Description
duobrii applied daily for 4 weeks followed by every other day for 4 weeks.
Primary Outcome Measure Information:
Title
Body surface area improvement
Description
body surface area determined by palm method where 1 palm is equivalent to 1%
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female adult ≥ 18 years of age;
Diagnosis of chronic plaque-type
Psoriasis affecting 2%-10% BSA
Patient is being treated with biologic therapy for a minimum of 24 weeks
Able and willing to give written informed consent prior to performance of any study-related procedures
Exclusion Criteria:
Psoriasis affecting ˂2% or >10% BSA
Patient not receiving a biologic agent, or receiving biologic agent <24weeks
Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.
Has previously used DUOBRII
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry Bagel, MD
Phone
6094434500
Email
dreamacres1@aol.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Nelson
Phone
6094434500
Email
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
Email
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
No
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Duobrii in Combination With Biologics
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