Duobrii in Combination With Biologics

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04119102
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Psoriasis Treatment Center of Central New Jersey
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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

Arms & Interventions

Arms

Experimental: Open Label Duobrii

Duobrii QD

Interventions

Drug: - Duobrii

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

East Windsor, New Jersey

Status

Recruiting

Address

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520

Site Contact

Elise Nelson

[email protected]

609-443-4500 #1402

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