Psoriasis VulgarisPhase 1NCT03669757
Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis
A Phase 1 study testing LEO 134310 and 0.1% betamethasone valerate ointment (class III steroid) in people with Psoriasis Vulgaris, run by LEO Pharma at 2 sites in Germany.
Trial summary
To assess safety and tolerability after treatment with LEO 134310 cutaneous solution. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 134310 and 0.1% betamethasone valerate ointment (class III steroid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesGermany
- Study dates
- 27 Sep 2018to 1 Feb 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.
- Men or women of non-child bearing potential.
Who cannot join
- Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
- According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Investigational Site
Hamburg, 20095
Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
About this study
Official title: A Phase 1b, Randomised, Controlled, Observer-blinded Trial to Assess Safety, Tolerability and Pharmacodynamic Effects of LEO 134310 Cutaneous Solution in Descaled Skin of Adults With Chronic Plaque Psoriasis
To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 134310, LEO 134310 vehicle, 0.1% betamethasone valerate ointment (class III steroid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 134310Drug
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
LEO 134310Drug
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
LEO 134310Drug
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
LEO 134310Drug
Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
LEO 134310 vehicleDrug
Active substance: none
0.1% betamethasone valerate ointment (class III steroid)Drug
Active substance: betamethasone valerate
| Study group | Role | What they receive |
|---|---|---|
| LEO 134310 Dose A | Experimental | Once daily application Receives: Drug: LEO 134310 |
| LEO 134310 Dose B | Experimental | Once daily application Receives: Drug: LEO 134310 |
| LEO 134310 Dose C | Experimental | Once daily application Receives: Drug: LEO 134310 |
| LEO 134310 Dose D | Experimental | Once daily application Receives: Drug: LEO 134310 |
| LEO 134310 vehicle | Placebo comparator | Once daily application Receives: Drug: LEO 134310 vehicle |
| 0.1% betamethasone valerate ointment (class III steroid) | Active comparator | Once daily application Receives: Drug: 0.1% betamethasone valerate ointment (class III steroid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall number of treatment-emergent adverse events.
Measured: Up to Day 19
Number of treatment-emergent application site reactions, by treatment.
Measured: Up to Day 19
Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters
red blood cells, white blood cells, hemoglobin, hematocrit, MCH, MMCV, MCHC, platelets, white cell differentials, measure in SI units
Measured: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters
sodium, potassium, chloride, bicarbonate, blood urea nitrogen, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gammaGT, uric acid, calcium, phosphate, albumin, triglycerides, cholesterol, lactate dehydrogenase, total protein, creatinine, total bilirubin, direct bilirubin, indirect bilirubin
Measured: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters
Single parameters only to be listed if deviation from usual urine dip test, e.g., sediment, leucocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin
Measured: Up to Day 12
Number of subjects with abnormal clinical significant ECG evaluation
Evaluation of 12-lead ECG (overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant')
Measured: Up to Day 12
Number of subjects with abnormal clinically significant findings of physical examination at Day 12.
Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant'
Measured: Up to Day 12
Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.
measured in mmHg
Measured: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in pulse.
measured in beats per minute
Measured: Up to Day 12
Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.
measured in degrees celsius
Measured: Up to Day 12
Secondary outcomes (2)
Change from baseline to Day 4, Day 8 and Day 12 in psoriatic infiltrate thickness (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography)
Measured: 12 days
Change from baseline to Day 12 in disease severity
Clinical assessment of change in disease severity (a global assessment performed by an investigator using a 5-point score ('-1 = worsened', '0 = unchanged', '1 = slight improvement', '2 = clear improvement but not completely healed', '3 = completely healed')
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start27 Sep 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intra-individual comparison of all treatment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669757
- Sponsor's protocol ID
- LP0155-1375
- Other IDs
- 2018-000140-26, 2018
- Status last verified
- Feb 2019
- First submitted
- 23 Aug 2018
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomised, Controlled, Observer-blinded Trial to Assess Safety, Tolerability and Pharmacodynamic Effects of LEO 134310 Cutaneous Solution in Descaled Skin of Adults With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03669757
- Acronym / sponsor ID
- LP0155-1375
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 13 Sep 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.
To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
- Model description
- Intra-individual comparison of all treatment
| Arm | Type | Receives |
|---|---|---|
| LEO 134310 Dose A | Experimental | Drug: LEO 134310Once daily application |
| LEO 134310 Dose B | Experimental | Drug: LEO 134310Once daily application |
| LEO 134310 Dose C | Experimental | Drug: LEO 134310Once daily application |
| LEO 134310 Dose D | Experimental | Drug: LEO 134310Once daily application |
| LEO 134310 vehicle | Placebo comparator | Drug: LEO 134310 vehicleOnce daily application |
| 0.1% betamethasone valerate ointment (class III steroid) | Active comparator | Drug: 0.1% betamethasone valerate ointment (class III steroid)Once daily application |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects aged 18-64 years (inclusive) with plaque psoriasis in a chronic stable phase.
- Men or women of non-child bearing potential.
Key exclusion criteria (2 listed)
- Acute psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, pustular, exfoliative or inverse psoriasis.
- According to defined washout periods: topical antipsoriatic drugs (except salicylic acid in petroleum jelly); systemic antipsoriatics and biologics; ultraviolet (UV) therapy.
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 |
|---|---|---|
| LEO 134310Active substance: LEO 134310 is a compound in development at LEO Pharma A/S | Drug | LEO 134310 Dose A |
| LEO 134310Active substance: LEO 134310 is a compound in development at LEO Pharma A/S | Drug | LEO 134310 Dose B |
| LEO 134310Active substance: LEO 134310 is a compound in development at LEO Pharma A/S | Drug | LEO 134310 Dose C |
| LEO 134310Active substance: LEO 134310 is a compound in development at LEO Pharma A/S | Drug | LEO 134310 Dose D |
| LEO 134310 vehicleActive substance: none | Drug | LEO 134310 vehicle |
| 0.1% betamethasone valerate ointment (class III steroid)Active substance: betamethasone valerate | Drug | 0.1% betamethasone valerate ointment (class III steroid) |
Primary outcome
Overall number of treatment-emergent adverse events.
Time frame: Up to Day 19
Number of treatment-emergent application site reactions, by treatment.
Time frame: Up to Day 19
Change from baseline to Day 4, Day 8 and Day 12 in haematology parameters
Time frame: Up to Day 12
red blood cells, white blood cells, hemoglobin, hematocrit, MCH, MMCV, MCHC, platelets, white cell differentials, measure in SI units
Change from baseline to Day 4, Day 8 and Day 12 in clinical chemistry parameters
Time frame: Up to Day 12
sodium, potassium, chloride, bicarbonate, blood urea nitrogen, glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gammaGT, uric acid, calcium, phosphate, albumin, triglycerides, cholesterol, lactate dehydrogenase, total protein, creatinine, total bilirubin, direct bilirubin, indirect bilirubin
Change from baseline to Day 4, Day 8 and Day 12 in urinalysis parameters
Time frame: Up to Day 12
Single parameters only to be listed if deviation from usual urine dip test, e.g., sediment, leucocytes, nitrite, pH, protein, glucose, ketones, urobilinogen, bilirubin, blood/haemoglobin
Number of subjects with abnormal clinical significant ECG evaluation
Time frame: Up to Day 12
Evaluation of 12-lead ECG (overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant')
Number of subjects with abnormal clinically significant findings of physical examination at Day 12.
Time frame: Up to Day 12
Evaluation of physical examination (areas skin, heart, lung, abdomen, basic neurological status, general examination of eyes, ears, nose throat), overall evaluation, assessed by investigator as 'normal', 'abnormal not clinically significant', 'abnormal clinically significant'
Change from baseline to Day 4, Day 8, Day 12 in systolic and diastolic blood pressure.
Time frame: Up to Day 12
measured in mmHg
Change from baseline to Day 4, Day 8 and Day 12 in pulse.
Time frame: Up to Day 12
measured in beats per minute
Change from baseline to Day 4, Day 8 and Day 12 in oral body temperature.
Time frame: Up to Day 12
measured in degrees celsius
2 secondary outcomes
Change from baseline to Day 4, Day 8 and Day 12 in psoriatic infiltrate thickness (assessed by measurement of the thickness of the Echo Poor Band [EPB] of the inflammatory infiltrate using 22-MHz sonography)
Time frame: 12 days
Change from baseline to Day 12 in disease severity
Time frame: 12 days
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 26 Oct 2024.
- 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.
Study Director study director
LEO Pharma
2 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 LEO 134310 and 0.1% betamethasone valerate ointment (class III steroid) in people with Psoriasis Vulgaris, run by LEO Pharma at 2 sites in Germany.
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 2 inclusion and 2 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 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?
Overall number of treatment-emergent adverse events. (time frame: Up to Day 19). The study lists 10 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 26 Oct 2024.