Psoriasis VulgarisPhase 2NCT02888236
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
A Phase 2 study testing LEO 32731 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Germany.
Trial summary
A study of LEO 32731 in the treatment of psoriasis vulgaris Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 32731
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to 6 Jul 2017
- Phase
- Phase 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent
- Aged between 18 years and 65.
- Males or females of non-childbearing potential.
- Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis
- Have moderate to severe psoriasis vulgaris
- Candidates of systemic anti-psoriatic treatment and/or phototherapy
Who cannot join
- Subjects with therapy resistant psoriasis
- Previously exposed to apremilast
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris
- Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Universitätsmedizin Berlin, Dept. of Dermatology
Berlin, 10117
About this study
A study of LEO 32731 in the treatment of psoriasis vulgaris
Read the detailed description
This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 32731, LEO 32731 Placebo
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 32731Drug
LEO 32731 PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 32731 tablet | Experimental | LEO 32731 30 mg two times daily for 16 weeks Receives: Drug: LEO 32731 |
| LEO 32731 Placebo tablet | Placebo comparator | LEO 32731 placebo two times daily for 16 weeks Receives: Drug: LEO 32731 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI) at week 16
Measured: Week 16
Secondary outcomes (2)
Proportion of subjects with Physician's Global Assessment of Disease Severity (PGA) treatment success, defined as clear or almost clear at week 16
Measured: Week 16
Itch evaluated by itch Numerical Rating Scale (NRS) at week 16
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion20 Jun 2017
- Study completion6 Jul 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Philipp, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888236
- Sponsor's protocol ID
- LP0058-1072
- Status last verified
- Aug 2017
- First submitted
- 30 Aug 2016
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT02888236
- Acronym / sponsor ID
- LP0058-1072
- Conditions
- Psoriasis Vulgaris
- Keywords
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 2 Sep 2016 (estimated)
- 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 study of LEO 32731 in the treatment of psoriasis vulgaris
Detailed description
This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris
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 |
|---|---|---|
| LEO 32731 tablet | Experimental | Drug: LEO 32731LEO 32731 30 mg two times daily for 16 weeks |
| LEO 32731 Placebo tablet | Placebo comparator | Drug: LEO 32731 PlaceboLEO 32731 placebo two times daily for 16 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent
- Aged between 18 years and 65.
- Males or females of non-childbearing potential.
- Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis
- Have moderate to severe psoriasis vulgaris
Key exclusion criteria (4 listed)
- Subjects with therapy resistant psoriasis
- Previously exposed to apremilast
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris
- Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris
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 32731 | Drug | LEO 32731 tablet |
| LEO 32731 Placebo | Drug | LEO 32731 Placebo tablet |
Primary outcome
Psoriasis Area and Severity Index (PASI) at week 16
Time frame: Week 16
2 secondary outcomes
Proportion of subjects with Physician's Global Assessment of Disease Severity (PGA) treatment success, defined as clear or almost clear at week 16
Time frame: Week 16
Itch evaluated by itch Numerical Rating Scale (NRS) at week 16
Time frame: Week 16
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 28 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Sandra Philipp, PhD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 32731 in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site 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 6 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: finished, as of the sponsor's last update on 28 Aug 2017. 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 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 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?
Psoriasis Area and Severity Index (PASI) at week 16 (time frame: Week 16). 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 28 Aug 2017.