NCT04119102RecruitingPhase 4
Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.
Psoriasis Treatment Center of Central New Jersey1 site in 1 country25 target enrollmentStarted: October 14, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Body surface area improvement
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Open Label Duobrii
Experimental
Duobrii QD
Intervention: Duobrii (Drug)
Outcomes
Primary Outcomes
Body surface area improvement
Time Frame: 8 weeks
body surface area determined by palm method where 1 palm is equivalent to 1%
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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