Psoriasis VulgarisPhase 2NCT01116895
A Proof of Concept Study Comparing Three Doses of an Oral Solution of LEO 22811 With a Placebo Oral Solution for the Treatment of Psoriasis Vulgaris
A Phase 2 study testing LEO 22811 in people with Psoriasis Vulgaris, run by LEO Pharma at 2 sites in 2 countries.
Trial summary
An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment in subjects with psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 22811
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2010to Jul 2011
- 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
- Following verbal and written information about the trial the subject must provide signed and dated informed consent before any study related activity is carried out, including activities relating to the washout period.
- Clinical diagnosis of psoriasis vulgaris, for at least 6 months prior to randomisation, and currently covering at least 10% of the body surface area (BSA)
- Candidates for systemic anti-psoriatic treatment
- Psoriasis Area and Severity Index (PASI) ≥10
- Disease severity of moderate, severe or very severe according to the Investigators' Global Assessment of disease severity (IGA)
- Aged 18 years or above
Show all 9Show fewer
- Any race or ethnicity
- Males, surgically sterile females (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or post menopausal females (at least 1 year since last menses)
- Attending hospital outpatient clinic or the private practice of a dermatologist
Who cannot join
- Systemic treatment with biological therapies whether marketed or not with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- Etanercept - 4 weeks
- Adalimumab, alefacept, infliximab - 2 months
- Ustekinumab - 4 months
- Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g.corticosteroids, retinoids, immunosuppressants, methotrexate, cyclosporin or fumaric acid) within 4 weeks prior to randomisation
- PUVA therapy within 4 weeks prior to randomisation
Show all 22Show fewer
- UVB therapy within 2 weeks prior to randomisation
- Any topical treatment (except for emollients/ medicated shampoo) within 2 weeks prior to randomisation
- Initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g. beta-blockers, anti-malaria drugs, lithium) 2 weeks prior to randomisation and during the study
- Current diagnosis with erythrodermic, exfoliative or pustular psoriasis
- Other current skin conditions that may confound the evaluation of psoriasis vulgaris as judged by the Investigator
- Generally in good health and does not have any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, haematologic, or gastrointestinal disease, immunologic insufficiency, or other major diseases or current condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study
- Current active tuberculosis or latent tuberculosis
- Planned exposure to the sun during the study that may affect psoriasis vulgaris
- Known malignancy or history of malignancy (other than cervical carcinoma in situ, basal cell or squamous cell carcinoma) within the 5 year period prior to randomisation
- Live vaccination within the 4 weeks prior to randomisation
- Males who do not agree to use adequate contraception during the study (including follow-up) to ensure their partner does not become pregnant
- Known or suspected hypersensitivity to component(s) of the investigational product
- Current participation in any other interventional trial
- Treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
- Previously randomised in this study
- Known or, in the opinion of the Investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcohol abuse, drug dependency or psychotic state).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, G1V 4X7
About this study
Official title: An International, Multi-centre, Prospective, Randomised, Double-blind, 4-arm, Placebo Controlled, Parallel Group Study With 12 Weeks Once Daily Oral Treatment in Subjects With Psoriasis Vulgaris
An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment in subjects with psoriasis vulgaris.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 22811, Placebo
- Keywords
- Psoriasis Vulgaris, Systemic, Anti-psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 22811Drug
Oral solution
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LEO 22811 0.5 mg | Active comparator | LEO 22811 0.5 mg: Oral solution Receives: Drug: LEO 22811 |
| LEO 22811 1.5 mg | Active comparator | LEO 22811 1.5 mg: Oral solution Receives: Drug: LEO 22811 |
| LEO 22811 3.0 mg | Active comparator | LEO 22811 3.0 mg: Oral solution Receives: Drug: LEO 22811 |
| Placebo | Placebo comparator | Placebo: Oral solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Psoriasis Area and Severity Index (PASI)
The investigator made assessments of the extent and severity of clinical signs of the participant's psoriasis on specific areas of the body in terms of three clinical signs: redness, thickness and scaliness.
The extent of psoriatic involvement was recorded for each of four areas; head, arms, trunk and legs using the following scale:
- = no involvement
- = <10%
- = 10-29%
- = 30-49%
- = 50-69%
- = 70-89%
- = 90-100%
For each clinical sign a single score (0, 1, 2, 3 or 4) reflecting the average severity of all psoriatic lesions on the given body region was determined.
PASI was calculated based on the investigator's assessment of the disease locally (head, trunk, arm, legs) using the following formula:
Head: 0.1 (R + T + S)E = W Arms: 0.2 (R + T + S)E = X Trunk: 0.3 (R + T + S)E = Y Legs: 0.4 (R + T + S)E = Z R = score for redness; T = score for thickness, S = score for scaliness; E = score for extent The sum of W+X+Y+Z gives the total PASI that ranges from 0 to 72.
Measured: Baseline (Day 0) to end of treatment (Day 84)
Secondary outcomes (4)
Participants With at Least 75% Reduction in PASI (PASI 75)
Measured: From baseline (Day 0) to end of treatment (Day 84)
Participants With at Least 50% Reduction in PASI (PASI 50)
Measured: From baseline (Day 0) to end of treatment (Day 84)
Participants With "Controlled Disease" According to the Investigators' Global Assessment (IGA)
At Visits 1 to 8 the investigator made a global assessment of the disease severity (IGA) using a 6-point scale (clear, almost clear, mild, moderate, severe, very severe). This assessment represents average lesion severity on head, trunk, arm and legs. The assessment was based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. Participants classified as clear or almost clear according to IGA was considered to have "controlled disease".
Measured: At end of treatment (Day 84)
Participants With Satisfactory Response According to IGA
"Satisfactory response" was defined as participants classified as "Clear" or "Almost Clear" or "Mild" according to the IGA.
Measured: At end of treatment (Day 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionJul 2011
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Poulin, MD, Principal investigator, Centre de Recherche Dermatologique du Quebec Metropolitain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116895
- Sponsor's protocol ID
- LEO 22811-S22
- Status last verified
- Dec 2018
- First submitted
- 4 May 2010
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multi-centre, Prospective, Randomised, Double-blind, 4-arm, Placebo Controlled, Parallel Group Study With 12 Weeks Once Daily Oral Treatment in Subjects With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01116895
- Acronym / sponsor ID
- LEO 22811-S22
- Conditions
- Psoriasis Vulgaris
- Keywords
- Psoriasis Vulgaris, Systemic, Anti-psoriatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 3 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment in subjects with psoriasis vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEO 22811 0.5 mg | Active comparator | Drug: LEO 22811LEO 22811 0.5 mg: Oral solution |
| LEO 22811 1.5 mg | Active comparator | Drug: LEO 22811LEO 22811 1.5 mg: Oral solution |
| LEO 22811 3.0 mg | Active comparator | Drug: LEO 22811LEO 22811 3.0 mg: Oral solution |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: Oral solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Following verbal and written information about the trial the subject must provide signed and dated informed consent before any study related activity is carried out, including activities relating to the washout period.
- Clinical diagnosis of psoriasis vulgaris, for at least 6 months prior to randomisation, and currently covering at least 10% of the body surface area (BSA)
- Candidates for systemic anti-psoriatic treatment
- Psoriasis Area and Severity Index (PASI) ≥10
- Disease severity of moderate, severe or very severe according to the Investigators' Global Assessment of disease severity (IGA)
Key exclusion criteria (22 listed)
- Systemic treatment with biological therapies whether marketed or not with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g.corticosteroids, retinoids, immunosuppressants, methotrexate, cyclosporin or fumaric acid) within 4 weeks prior to randomisation
- PUVA therapy within 4 weeks prior to randomisation
- UVB therapy within 2 weeks prior to randomisation
- Any topical treatment (except for emollients/ medicated shampoo) within 2 weeks prior to randomisation
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 22811Oral solution | Drug | LEO 22811 0.5 mg, LEO 22811 1.5 mg, LEO 22811 3.0 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percentage Change in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline (Day 0) to end of treatment (Day 84)
The investigator made assessments of the extent and severity of clinical signs of the participant's psoriasis on specific areas of the body in terms of three clinical signs: redness, thickness and scaliness. The extent of psoriatic involvement was recorded for each of four areas; head, arms, trunk and legs using the following scale: 0. = no involvement 1. = <10% 2. = 10-29% 3. = 30-49% 4. = 50-69% 5. = 70-89% 6. = 90-100% For each clinical sign a single score (0, 1, 2, 3 or 4) reflecting the average severity of all psoriatic lesions on the given body region was determined. PASI was calculated based on the investigator's assessment of the disease locally (head, trunk, arm, legs) using the following formula: Head: 0.1 (R + T + S)E = W Arms: 0.2 (R + T + S)E = X Trunk: 0.3 (R + T + S)E = Y Legs: 0.4 (R + T + S)E = Z R = score for redness; T = score for thickness, S = score for scaliness; E = score for extent The sum of W+X+Y+Z gives the total PASI that ranges from 0 to 72.
4 secondary outcomes
Participants With at Least 75% Reduction in PASI (PASI 75)
Time frame: From baseline (Day 0) to end of treatment (Day 84)
Participants With at Least 50% Reduction in PASI (PASI 50)
Time frame: From baseline (Day 0) to end of treatment (Day 84)
Participants With "Controlled Disease" According to the Investigators' Global Assessment (IGA)
Time frame: At end of treatment (Day 84)
Participants With Satisfactory Response According to IGA
Time frame: At end of treatment (Day 84)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- 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.
Yves Poulin, MD principal investigator
Centre de Recherche Dermatologique du Quebec Metropolitain
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 22811 in people with Psoriasis Vulgaris, run by LEO Pharma at 2 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 9 inclusion and 22 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 7 Mar 2025. 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 Canada, France. 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 3 Oct 2018). 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?
Percentage Change in Psoriasis Area and Severity Index (PASI) (time frame: Baseline (Day 0) to end of treatment (Day 84)). 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 7 Mar 2025.