Duobrii in Combination With Biologics
Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.
1 other identifier
interventional
25
1 country
1
Brief Summary
12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedStudy Start
First participant enrolled
October 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedApril 30, 2020
April 1, 2020
10 months
October 3, 2019
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Body surface area improvement
body surface area determined by palm method where 1 palm is equivalent to 1%
8 weeks
Study Arms (1)
Open Label Duobrii
EXPERIMENTALDuobrii QD
Interventions
duobrii applied daily for 4 weeks followed by every other day for 4 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 8, 2019
Study Start
October 14, 2019
Primary Completion
August 1, 2020
Study Completion
September 1, 2020
Last Updated
April 30, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share