Psoriatic PlaquePhase 1/2NCT03630939
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 in Subjects With Plaque Psoriasis
A Phase 1/2 study testing ESR-114 in people with Psoriatic Plaque, run by Escalier Biosciences B.V. at 10 sites in 2 countries.
Trial summary
This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Plaque
- What is being tested?
- ESR-114
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 9 Aug 2018to 12 Jun 2019
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a history of plaque psoriasis for at least 6 months.
- Subject has PGA of mild (2) or moderate (3) at Day 1.
- Subject has total LSS of ≥6 at Day 1.
- Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1.
Who cannot join
- Subject has non-plaque psoriasis at Screening and Day 1.
- Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day 1.
- Subject has used any topical therapy to treat psoriasis within 2 weeks prior to Day 1.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Study Site 12
Austin, Texas, 78759
Study Site 11
College Station, Texas, 77845
Study Site 17
Fridley, Minnesota, 55432
Study Site 15
Houston, Texas, 77056
Study Site 14
Raleigh, North Carolina, 27612
Study Site 18
San Antonio, Texas, 78213
Study Site 19
Santa Monica, California, 90404
Study Site 16
Tampa, Florida, 33624
Canada2 sites
Study Site 10
Montreal, Quebec, H2K 4L5
Study Site 13
Peterborough, Ontario, K9J 5K2
About this study
Official title: A Multicenter, Double-Blind, Randomized, Vehicle-Controlled Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 Gel in Subjects With Plaque Psoriasis
This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).
- Conditions
- Psoriatic Plaque
- Being tested
- ESR-114, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESR-114Drug
ESR-114 Topical Gel
PlaceboOther
Placebo Topical Gel
| Study group | Role | What they receive |
|---|---|---|
| ESR-114 1.5% | Experimental | ESR-114 1.5% Topical Gel BID for 6 weeks Receives: Drug: ESR-114 |
| ESR-114 5.0% | Experimental | ESR-114 5.0% Topical Gel BID for 6 weeks Receives: Drug: ESR-114 |
| Vehicle Gel | Placebo comparator | Placebo Topical Gel BID for 6 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Lesion Severity Score
Change from Baseline in Total Lesion Severity Score (sum of scores for Induration, Erythema, \& Desquamation; score range: 0-12; lower score is better outcome) at Week 6
Measured: 6 weeks
Secondary outcomes (5)
Proportion of subjects with clear or almost clear on the Physician Global Assessment
Proportion of subjects with clear or almost clear on the Physician Global Assessment (PGA) at Week 6
Measured: 6 weeks
Proportion of subjects with PASI75
Proportion of subjects with PASI75 at Week 6
Measured: 6 weeks
Change from Baseline in erythema score over time
Change from Baseline in erythema score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Measured: 6 weeks
Change from Baseline in induration score over time
Change from Baseline in induration score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Measured: 6 weeks
Change from Baseline in desquamation score over time
Change from Baseline in desquamation score (score range: 0-4; lower score is better outcome) at Weeks 1, 2, 4, and 6
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start9 Aug 2018
- Primary completion5 Jun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic PlaqueStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escalier Biosciences B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Responsible party
- Sponsor
- Investigators
- Allison Luo, MD, Study chair, Escalier Biosciences B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630939
- Sponsor's protocol ID
- ESR-114-101
- Status last verified
- Jul 2020
- First submitted
- 10 Aug 2018
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Vehicle-Controlled Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Topical ESR-114 Gel in Subjects With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03630939
- Acronym / sponsor ID
- ESR-114-101
- Conditions
- Psoriatic Plaque
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Escalier Biosciences B.V.Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 15 Aug 2018 (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.
This is a multicenter, double-blind, randomized, vehicle-controlled, parallel-group proof-of-concept study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of topically applied ESR-114 following twice daily (BID) application for 42 days (6 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESR-114 1.5% | Experimental | Drug: ESR-114ESR-114 1.5% Topical Gel BID for 6 weeks |
| ESR-114 5.0% | Experimental | Drug: ESR-114ESR-114 5.0% Topical Gel BID for 6 weeks |
| Vehicle Gel | Placebo comparator | Other: PlaceboPlacebo Topical Gel BID for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has a history of plaque psoriasis for at least 6 months.
- Subject has PGA of mild (2) or moderate (3) at Day 1.
- Subject has total LSS of ≥6 at Day 1.
- Subjects with plaque psoriasis-affected BSA to be treated of 1% to 15% at Screening and Day 1.
Key exclusion criteria (3 listed)
- Subject has non-plaque psoriasis at Screening and Day 1.
- Subject has a history of skin disease or presence of skin condition that, in the opinion of the Investigator, would interfere with the study assessments at Screening and Day 1.
- Subject has used any topical therapy to treat psoriasis within 2 weeks 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 |
|---|---|---|
| ESR-114ESR-114 Topical Gel | Drug | ESR-114 1.5%, ESR-114 5.0% |
| PlaceboPlacebo Topical Gel | Other | Vehicle Gel |
Primary outcome
Change in Total Lesion Severity Score
Time frame: 6 weeks
Change from Baseline in Total Lesion Severity Score (sum of scores for Induration, Erythema, \& Desquamation; score range: 0-12; lower score is better outcome) at Week 6
5 secondary outcomes
Proportion of subjects with clear or almost clear on the Physician Global Assessment
Time frame: 6 weeks
Proportion of subjects with PASI75
Time frame: 6 weeks
Change from Baseline in erythema score over time
Time frame: 6 weeks
Change from Baseline in induration score over time
Time frame: 6 weeks
Change from Baseline in desquamation score over time
Time frame: 6 weeks
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 29 Jul 2020.
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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.
Allison Luo, MD study chair
Escalier Biosciences B.V.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ESR-114 in people with Psoriatic Plaque, run by Escalier Biosciences B.V. at 10 sites in 2 countries.
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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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 combined 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.
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?
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?
Change in Total Lesion Severity Score (time frame: 6 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 29 Jul 2020.