Plaque PsoriasisPhase 2NCT03837743
Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis
A Phase 2 study testing DUR-928 Topical Solution in people with Plaque Psoriasis, run by Durect at 5 sites in United States.
Trial summary
This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- DUR-928 Topical Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Feb 2019to 20 May 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is a male or non-pregnant female 18 years of age or older.
- Subject has provided written informed consent.
- Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months.
- Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 2/Baseline.
- Males (or their female partner) must agree to use an effective method of birth control throughout the study.
- Subject has two similar contralateral Target Plaques.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis.
- Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has been previously enrolled in this study and treated with test article.
- Other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Site 04
Miami, Florida, 33162
Site 02
Plainfield, Indiana, 46168
Site 01
San Diego, California, 92123
Site 03
Spokane, Washington, 99202
Site 05
Tampa, Florida, 33609
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis
This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.
- Conditions
- Plaque Psoriasis
- Being tested
- DUR-928 Topical Solution, Vehicle Topical Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUR-928 Topical SolutionDrug
Topical solution containing active drug
Vehicle Topical SolutionDrug
Topical solution containing no active drug
| Study group | Role | What they receive |
|---|---|---|
| DUR-928 Topical Solution | Experimental | DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. Receives: Drug: DUR-928 Topical Solution |
| Vehicle Topical Solution | Placebo comparator | Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. Receives: Drug: Vehicle Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
Measured: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Secondary outcomes (4)
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe.
Measured: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)
The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe.
Measured: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed by the Target Plaque Area.
The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.
Measured: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.
The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
Measured: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start21 Feb 2019
- Primary completion11 Nov 2019
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durect
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Tony Andrasfay, Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837743
- Sponsor's protocol ID
- C928-015
- Status last verified
- Aug 2022
- First submitted
- 5 Feb 2019
- Last updated
- 2 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03837743
- Acronym / sponsor ID
- C928-015
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- DurectIndustry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 2 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DUR-928 Topical Solution | Experimental | Drug: DUR-928 Topical SolutionDUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. |
| Vehicle Topical Solution | Placebo comparator | Drug: Vehicle Topical SolutionVehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is a male or non-pregnant female 18 years of age or older.
- Subject has provided written informed consent.
- Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months.
- Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 2/Baseline.
- Males (or their female partner) must agree to use an effective method of birth control throughout the study.
Key exclusion criteria (7 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis.
- Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient during the study.
- Subject is currently enrolled in an investigational drug or device study.
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 |
|---|---|---|
| DUR-928 Topical SolutionTopical solution containing active drug | Drug | DUR-928 Topical Solution |
| Vehicle Topical SolutionTopical solution containing no active drug | Drug | Vehicle Topical Solution |
Primary outcome
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score.
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe
4 secondary outcomes
The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema)
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI)
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed by the Target Plaque Area.
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus.
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Tony Andrasfay study director
Therapeutics, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DUR-928 Topical Solution in people with Plaque Psoriasis, run by Durect at 5 sites 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. (time frame: Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)). 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 2 Sep 2022.