PsoriasisPhase 4NCT04119102
Duobrii in Combination With Biologics
A Phase 4 study testing Duobrii in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Duobrii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Elise Nelson, 609-443-4500 ext. 1402, enelson@windsordermatology.com
Jerry Bagel, MD
About this study
Official title: Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.
12 weeks DUOBRII to patients with 2%-10% BSA who are receiving biologic therapy for at least 24 weeks
Read the 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
- Conditions
- Psoriasis
- Being tested
- Duobrii
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuobriiDrug
duobrii applied daily for 4 weeks followed by every other day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Duobrii | Experimental | Duobrii QD Receives: Drug: Duobrii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body surface area improvement
body surface area determined by palm method where 1 palm is equivalent to 1%
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start14 Oct 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Dermatologics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119102
- Sponsor's protocol ID
- PTC07
- Status last verified
- Apr 2020
- First submitted
- 3 Oct 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study Evaluating DUOBRII in Psoriasis Patients Being Treated With Biologic Agents.
- ClinicalTrials.gov ID
- NCT04119102
- Acronym / sponsor ID
- PTC07
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Collaborators
- Ortho Dermatologics
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| Open Label Duobrii | Experimental | Drug: DuobriiDuobrii QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duobriiduobrii applied daily for 4 weeks followed by every other day for 4 weeks. | Drug | Open Label Duobrii |
Primary outcome
Body surface area improvement
Time frame: 8 weeks
body surface area determined by palm method where 1 palm is equivalent to 1%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duobrii in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerry Bagel, MD (6094434500, dreamacres1@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body surface area improvement (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.