Plaque PsoriasisPhase 1NCT04203433
A Study of DLX105-DMP in Subjects With Plaque Psoriasis
A Phase 1 study testing DLX105-DMP in people with Plaque Psoriasis, run by DelArrivo, Inc. at 4 sites in United States.
Trial summary
A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- DLX105-DMP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Mar 2022to 1 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent.
- Subjects aged 18-75 years.
- Male subject, or if female, must be surgically sterile, post-menopausal, or using acceptable birth control.
- Stable chronic mild-to-moderate plaque psoriasis.
Who cannot join
- Non-plaque-type psoriasis only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, or plantar) at Screening.
- Drug-induced psoriasis (i.e., new onset or exacerbation from beta-blockers, calcium channel inhibitors or lithium) within 3 months prior to Day 1.
- Ongoing use of psoriasis treatments or inadequate duration of washout prior to Day 1
Trial locations and contacts
4 sites in 1 country.
United States4 sites
DelArrivo Investigational Site
Alpharetta, Georgia, 30022
DelArrivo Investigational Site
Norfolk, Virginia, 23502
DelArrivo Investigational Site
Philadelphia, Pennsylvania, 19103
DelArrivo Investigational Site
San Antonio, Texas, 78229
About this study
Official title: A Pilot, Open-Label Study in Subjects With Mild-to-Moderate Plaque Psoriasis to Investigate the Dosing Feasibility, Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multi-dose Regimen of DLX105-DMP Administered to a Target Lesion
A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion
- Conditions
- Plaque Psoriasis
- Being tested
- DLX105-DMP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLX105-DMPDrug
1mg applied to target lesion
| Study group | Role | What they receive |
|---|---|---|
| DLX105-DMP Multi-Dose Twice Weekly | Experimental | 4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly Receives: Drug: DLX105-DMP |
| DLX105-DMP Multi-Dose Once Weekly | Experimental | 4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly Receives: Drug: DLX105-DMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tolerability Sensations
4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe
Measured: Up to 4 Weeks
Local Site Application Assessment
Investigator Assessment of Site Application Area using a 5-point scale: 0 = no visible reaction to 4 = severe erythema with induration/vesicles
Measured: Up to 4 Weeks
Adverse Events
Treatment Emergent Adverse Events
Measured: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Local Investigator Global Assessment (IGA)
Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe
Measured: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)
Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12.
Measured: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Secondary outcomes (2)
Pharmacokinetic Parameters
DLX105 concentrations in samples collected over time
Measured: Day 1, Day 15, and Day 25
Immunogenicity Testing
Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time
Measured: Up to 4 Weeks after Last Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start21 Mar 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- DelArrivo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203433
- Sponsor's protocol ID
- DLX105-DMP-201
- Status last verified
- Apr 2023
- First submitted
- 16 Dec 2019
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to make individual participant data available to other researchers; however, if study results are published, then de-identified IPD may be made available in connection with the publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label Study in Subjects With Mild-to-Moderate Plaque Psoriasis to Investigate the Dosing Feasibility, Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multi-dose Regimen of DLX105-DMP Administered to a Target Lesion
- ClinicalTrials.gov ID
- NCT04203433
- Acronym / sponsor ID
- DLX105-DMP-201
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- DelArrivo, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 Dec 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.
A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLX105-DMP Multi-Dose Twice Weekly | Experimental | Drug: DLX105-DMP4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly |
| DLX105-DMP Multi-Dose Once Weekly | Experimental | Drug: DLX105-DMP4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent.
- Subjects aged 18-75 years.
- Male subject, or if female, must be surgically sterile, post-menopausal, or using acceptable birth control.
- Stable chronic mild-to-moderate plaque psoriasis.
Key exclusion criteria (3 listed)
- Non-plaque-type psoriasis only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, or plantar) at Screening.
- Drug-induced psoriasis (i.e., new onset or exacerbation from beta-blockers, calcium channel inhibitors or lithium) within 3 months prior to Day 1.
- Ongoing use of psoriasis treatments or inadequate duration of washout prior to Day 1
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 |
|---|---|---|
| DLX105-DMP1mg applied to target lesion | Drug | DLX105-DMP Multi-Dose Once Weekly, DLX105-DMP Multi-Dose Twice Weekly |
Primary outcome
Local Tolerability Sensations
Time frame: Up to 4 Weeks
4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe
Local Site Application Assessment
Time frame: Up to 4 Weeks
Investigator Assessment of Site Application Area using a 5-point scale: 0 = no visible reaction to 4 = severe erythema with induration/vesicles
Adverse Events
Time frame: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Treatment Emergent Adverse Events
Local Investigator Global Assessment (IGA)
Time frame: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe
Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)
Time frame: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12.
2 secondary outcomes
Pharmacokinetic Parameters
Time frame: Day 1, Day 15, and Day 25
Immunogenicity Testing
Time frame: Up to 4 Weeks after Last Dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No. There is no current plan to make individual participant data available to other researchers; however, if study results are published, then de-identified IPD may be made available in connection with the publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DLX105-DMP in people with Plaque Psoriasis, run by DelArrivo, Inc. at 4 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 4 inclusion and 3 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Local Tolerability Sensations (time frame: Up to 4 Weeks). The study lists 5 primary outcomes in all. 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 3 May 2023.