Duobrii in Combination With Biologics

Phase 4

Recruiting

• Conditions: Psoriasis
• Interventions: Drug: Duobrii

• Registration Number: NCT04119102
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

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 Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-08
• Study Start: 2019-10-14
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Duobrii	Duobrii	Duobrii QD

Primary Outcome Measures

Name	Time	Method
Body surface area improvement	8 weeks	body surface area determined by palm method where 1 palm is equivalent to 1%

Trial Locations

Locations (1)

Psoriasis Treatment Center of Central New Jersey; 🇺🇸 East Windsor, New Jersey, United States