A research study to evaluate the efficacy of LEO 32731 oral tablet formulation in patients with moderate to severe psoriasis vulgaris.
- Conditions
- Psoriasis VulgarisMedDRA version: 19.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-005279-25-DE
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
• Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis (max. of 4 joints with active arthritis ) for at least 6 months prior to Screening Visit 2 (SV2).
• Have moderate to severe psoriasis vulgaris at SV2 and Visit 1 as defined by:
a. Psoriasis Area and Severity Index (PASI) > 10 and
b. Covering > 10% of the body surface area (BSA) and
c. Disease severity of moderate or worse (PGA = 3) according to the Physician´s Global Assessment of disease severity (PGA).
• Candidates of systemic anti-psoriatic treatment and/or phototherapy.
• Female subjects must be of non-childbearing potential, i.e. post-menopausal for at least 1 year, or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or have undergone tubal litigation)
• Male subjects with pregnant partner or with partners of childbearing potential must be willing to use a condom until end of trial, including the 2 weeks follow up period.
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 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Subjects with therapy resistant psoriasis defined as: Two or more treatment failures due to inadequate efficacy within the past 5 years of the following treatment classes (systemic therapies) administered in adequate dose and duration according to the label or guidelines (local/national). Subjects who stopped systemic treatment for reasons not related to lack of efficacy should not be excluded
a. Oral systemic therapies including but not limited to methotrexate, cyclosporine, retinoids, corticosteroids, apremilast and fumaric acid
b. Biological therapies including but not limited to etanercept, secukinumab, adalimumab, infliximab and ustekinumab
c. Light therapy (PUVA and UVB).
• Previously exposed to apremilast.
• Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1:
a. Etanercept – 4 weeks
b. Adalimumab, certolizumab and infliximab – 2 months
c. Ustekinumab and secukinumab – 4 months.
• Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants, methotrexate, cyclosporine or fumaric acid) within 4 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
• Use of anticoagulants/antiplatelets (e.g., warfarin, clopidogrel or ticlopidine) within 4 weeks prior to Visit 1.
• Use of topical antibiotics within 2 weeks prior to Visit 1 (short term use of systemic antibiotics are allowed).
• Light therapy (PUVA or UVB) within 4 weeks prior to Visit 1.
• Any topical treatment (except for emollients/non-steroid medicated shampoo) within 2 weeks prior to Visit 1.
• Initiation of, or changes of doses to concomitant medication that could affect psoriasis vulgaris (e.g., beta-blockers, ACE inhibitors, anti-malaria drugs, lithium) within 4 weeks prior to Visit 1 and throughout the trial.
• Concomitant medication that are metabolized via cytochrome P 450 3A4 isozyme (Appendix 5) within 4 weeks prior to Visit 1, during the treatment period and during follow-up.
• Current diagnosis with guttate, erythrodermic, exfoliative or pustular psoriasis, or other skin conditions that may confound the evaluation of psoriasis vulgaris as judged by the Investigator.
• Subjects with a positive HBV core antibody, HBsAg, anti-HCV or anti-HIV test at SV2.
• ALT or AST >2.5 x ULN at SV2.
• Serum creatinine =1.5 mg/dl at SV2. For a subject with a value of =1.5 mg/dl, a creatinine clearance of =60 mL/min using a Cockroft-Gault formula will be allowed.
• Overt Proteinuria (defined as = +2 on urine dipstick) as deemed clinically significant at SV2.
• Two consecutive measurements of supine systemic blood pressure >150/95 mmHg or <90/50 mmHg at SV2 taken 5 minutes apart.
•A marked baseline prolongation of a QTcF interval > 450 ms for males and > 470 ms for females or PR interval >220 ms or QRS interval > 110 ms or a clinically significant ECG at SV2.
• Clinically significant cardiac, endocrinologic, pulmonary, neurologic, hepatic, renal, haematologic, or gastrointestinal disease, immunologic insufficiency, or other major diseases or current condition which, in the opinion of the Investigator, makes the subject unable to participate in the trial, or a current or a history of major depressive disorder within the last 5 years, or any depressive disorder within last 12 months, or another significant psychiatric d
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris.;Secondary Objective: To investigate the effect on psoriasis symptoms during 16 weeks of twice daily treatment with 30 mg of LEO 32731 and LEO 32731 placebo.<br>To investigate the effect on itch intensity after 16 weeks of twice daily treatment with 30 mg of LEO 32731 and LEO 32731 placebo.<br>To investigate the safety and tolerability during 16 weeks of twice daily treatment with 30 mg of LEO 32731 and LEO 32731 placebo.<br>;Primary end point(s): PASI ;Timepoint(s) of evaluation of this end point: week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PGA treatment success (defined as Clear” or Almost Clear”) according to PGA at week 16<br>Itch evaluated by Itch NRS at week 16<br>;Timepoint(s) of evaluation of this end point: PGA treatment success : week 16<br>Itch evaluated by Itch NRS: week 16