A phase 2a 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 1

• Conditions: MedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris; Psoriasis vulgaris

• Registration Number: EUCTR2009-017858-12-FR
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-29
• Study Completion: 2011-07-25
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1.1 Signed informed consent has been obtained
1.2 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)
1.3 Candidates for systemic anti-psoriatic treatment
1.4 Psoriasis Area and Severity Index (PASI) =10
1.5 Disease severity of moderate, severe or very severe according to the Investigators’ Global Assessment of disease severity (IGA)
1.6 Aged 18 years or above
1.7 Any race or ethnicity
1.8 Males, surgically sterile females (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or post menopausal females (at least 1 year since last menses)
1.9 Attending hospital outpatient clinic or the private practice of a dermatologist.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

2.1 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
2.2 Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, immunosuppressants, meth-otrexate, cyclosporin or fumaric acid) within 4 weeks prior to randomisation
2.3 PUVA therapy within 4 weeks prior to randomisation
2.4 UVB therapy within 2 weeks prior to randomisation
2.5 Any topical treatment (except for emollients/medicated shampoo) within 2 weeks prior to randomisation
2.6 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
2.7 Current diagnosis with erythrodermic, exfoliative or pustular psoriasis
2.8 Other current skin conditions that may confound the evaluation of psoriasis vulgaris as judged by the Investigator
2.9 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
2.10 Current active tuberculosis or latent tuberculosis
2.11 Planned exposure to the sun during the study that may affect psoriasis vulgaris
2.12 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
2.13 Live vaccination within the 4 weeks prior to randomisation
2.14 Males who do not agree to use adequate contraception during the study (including follow-up) to ensure their partner does not become pregnant
2.15 Known or suspected hypersensitivity to component(s) of investigational products
2.16 Current participation in any other interventional clinical trial
2.17 Subjects who have received 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
2.18 Previously randomised in this trial
2.19 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 clinical trial of medicinal product
• Study Design: Not specified