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

Phase 2

Completed

Conditions: Psoriasis Vulgaris

Interventions: Drug: Placebo
Drug: LEO 22811

Registration Number: NCT01116895

Lead Sponsor: LEO Pharma

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

Inclusion Criteria

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
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

Exclusion Criteria

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
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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo: Oral solution
LEO 22811 0.5 mg	LEO 22811	LEO 22811 0.5 mg: Oral solution
LEO 22811 3.0 mg	LEO 22811	LEO 22811 3.0 mg: Oral solution
LEO 22811 1.5 mg	LEO 22811	LEO 22811 1.5 mg: Oral solution

Primary Outcome Measures

Name	Time	Method
Percentage Change in Psoriasis Area and Severity Index (PASI)	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.

Secondary Outcome Measures

Name	Time	Method
Participants With at Least 75% Reduction in PASI (PASI 75)	From baseline (Day 0) to end of treatment (Day 84)
Participants With at Least 50% Reduction in PASI (PASI 50)	From baseline (Day 0) to end of treatment (Day 84)
Participants With "Controlled Disease" According to the Investigators' Global Assessment (IGA)	At end of treatment (Day 84)	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".
Participants With Satisfactory Response According to IGA	At end of treatment (Day 84)	"Satisfactory response" was defined as participants classified as "Clear" or "Almost Clear" or "Mild" according to the IGA.

Trial Locations

Locations (2): Hôpital Saint-Louis, Service de Dermatologie
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Paris, France
Centre de Recherche Dermatologique du Quebec Metropolitain
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Québec, Canada