Duobrii in Combination With Biologics

NCT ID: NCT04119102

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2020-09-01

Brief Summary

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12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks

Detailed Description

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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

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

open label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Duobrii

Duobrii QD

Group Type EXPERIMENTAL

Duobrii

Intervention Type DRUG

duobrii applied daily for 4 weeks followed by every other day for 4 weeks.

Interventions

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Duobrii

duobrii applied daily for 4 weeks followed by every other day for 4 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female adult ≥ 18 years of age;
2. Diagnosis of chronic plaque-type
3. Psoriasis affecting 2%-10% BSA
4. Patient is being treated with biologic therapy for a minimum of 24 weeks
5. Able and willing to give written informed consent prior to performance of any study-related procedures

Exclusion Criteria

1. Psoriasis affecting ˂2% or \>10% BSA
2. Patient not receiving a biologic agent, or receiving biologic agent \<24weeks
3. Received treatment with any topical antipsoriatic drug product within 14 days prior to the Baseline visit.
4. Has previously used DUOBRII
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ortho Dermatologics

INDUSTRY

Sponsor Role collaborator

Psoriasis Treatment Center of Central New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jerry Bagel, MD

Role: CONTACT

6094434500

Elise Nelson

Role: CONTACT

6094434500

Facility Contacts

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Elise Nelson

Role: primary

609-443-4500 ext. 1402

Other Identifiers

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PTC07

Identifier Type: -

Identifier Source: org_study_id

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