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Recruiting

NCT Number: NCT04119102

Duobrii in Combination With Biologics

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

Recruiting

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location status: Recruiting

Location contact

Alexa Hetzel, PA-C

SUB_INVESTIGATOR

Brian Keegan, MD, PhD

SUB_INVESTIGATOR

David Nieves, MD

SUB_INVESTIGATOR

Elise Nelson

CONTACT

[email protected]

609-443-4500 ext. 1402

Jerry Bagel, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duobrii

Drug

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

Primary outcomes

  1. Body surface area improvement

    Time frame: 8 weeks

    body surface area determined by palm method where 1 palm is equivalent to 1%

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Nelson

CONTACT

[email protected]

6094434500

Jerry Bagel, MD

CONTACT

[email protected]

6094434500

Sponsors and collaborators

Lead sponsor

Psoriasis Treatment Center of Central New Jersey

Other

Collaborators

  • Ortho Dermatologics

Registry information

Official study title

Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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