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

NCT01116895 | Completed Phase 2 Results DMC

• 1 other identifier: LEO 22811-S22
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 2

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.

Conditions

Psoriasis Vulgaris

Keywords

Psoriasis Vulgaris; Systemic; Anti-psoriatic

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  Baseline (Day 0) to end of treatment (Day 84)

Secondary Outcomes (4)

• 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)

• Participants With Satisfactory Response According to IGA

  At end of treatment (Day 84)

Study Arms (4)

LEO 22811 0.5 mg

ACTIVE COMPARATOR

LEO 22811 0.5 mg: Oral solution

Drug: LEO 22811

LEO 22811 1.5 mg

ACTIVE COMPARATOR

LEO 22811 1.5 mg: Oral solution

Drug: LEO 22811

LEO 22811 3.0 mg

ACTIVE COMPARATOR

LEO 22811 3.0 mg: Oral solution

Drug: LEO 22811

Placebo

PLACEBO COMPARATOR

Placebo: Oral solution

Drug: Placebo

Interventions

LEO 22811 DRUG

Oral solution

LEO 22811 0.5 mg; LEO 22811 1.5 mg; LEO 22811 3.0 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, G1V 4X7, Canada

Location

Hôpital Saint-Louis, Service de Dermatologie

Paris, France

Location

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Yves Poulin, MD

  Centre de Recherche Dermatologique du Quebec Metropolitain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 7, 2025
• Results First Posted: October 3, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); CA (1)