None listed
Conditions
Brief summary
This is a Phase II study to determine the safety, tolerability and efficacy of topical doses of AKP-11 when administered to participants with mild to moderate psoriasis. AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist, developed by Akaal Pharma PTY LTD. AKP-11 targets the immune activity, inhibits the over-expression of pro-inflammatory cytokines and factors including the inflammation. AKP-11 has been tested in several immune/ inflammatory diseases including psoriasis patients (Phase I) in order to establish its efficacy. The twice daily topical application of 0.5 g of 3% ointment containing 15 mg AKP-11 or matching placebo in up to 65 participants for 41 days. Participants will be randomized 1 to 1 into 3% AKP-11 and Placebo groups respectively.
Interventions
AKP-11 is a small molecule entity with anti-inflammatory activity. The study involves the daily topical administration of ~1 g of 3% topical AKP-11 formulation (~0.5 g 2 x times a Day) and matching placebo to up to 65 participants with plaque psoriasis to a target site (one or more plaques with or without healthy skin) with an area of up to the size of 121 cm2, identified by an investigator, for 6 weeks. Participants will be randomized 1:1 into AKP-11 formulation/placebo groups. At every visit
AKP-11 is a small molecule entity with anti-inflammatory activity. The study involves the daily topical administration of ~1 g of 3% topical AKP-11 formulation (~0.5 g 2 x times a Day) and matching placebo to up to 65 participants with plaque psoriasis to a target site (one or more plaques with or without healthy skin) with an area of up to the size of 121 cm2, identified by an investigator, for 6 weeks. Participants will be randomized 1:1 into AKP-11 formulation/placebo groups. At every visit, the participant needs to return used and unused sachet/s to the study personal for accountability purposes.
Sponsors
Akaal Pharma Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*Males or females aged 18 years and older (inclusive) at the time of screening. *Mild to moderate plaque psoriasis with a PASI score between 1 and 10. *The target plaque equal to or greater than 5 cm2 with TPSS equal to or greater than 5 and induration (thickness) sub-score of 2 or greater (based on diagnosis by a suitably qualified Investigator). *Duration of psoriasis of at least 6 months or more and stable disease in both extent and severity for at least two weeks prior to the commencement of study treatment. *Able to provide written informed consent prior to the performance of any study specific procedures. *Participants with a BMI between 18.0 and 40.0 kg/m2, inclusive. *Female participants of child-bearing potential with negative pregnancy test at screening and negative urine pregnancy test at check-in (Day 1), AND; *Agrees to abstinence for the duration of the study and until 4 weeks after dosing with study drug, if this is in line with the usual lifestyle; *OR agrees to use condoms plus one other acceptable form of contraception; i.e. intra-uterine device, hormonal contraception or a female diaphragm, from screening until 4 weeks after dosing with study drug; *OR has only same-sex partners, when this is her preferred and usual lifestyle; *OR has a vasectomized partner. *Male participants with female partners of child-bearing potential must agree abstinence or to use condoms plus partner use of an acceptable contraceptive (intrauterine device, hormonal contraception or male condom plus female diaphragm) for the duration of the study and until 4 weeks after dosing with study drug. *Negative test results for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C at the time of screening. *Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule.
Exclusion criteria
*Participants with erythrodermic, guttate, palmar, plantar or generalised pustular forms of psoriasis or participants with scalp, palmar or plantar psoriasis only. *Participants with any skin condition other than psoriasis, in particular eczema, cutaneous infections, significant sun damage or an inherited skin disorder (other than psoriasis). *History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations. *Participants who have smoked more than 10 cigarettes a day in the last 12 months. *Treatment with any of the following within 4 weeks prior to the commencement of study treatment and for the duration of the study: systemic retinoids; immunosuppressant agents (e.g. methotrexate, cyclosporine, azathioprine, thioguanine prednisone, prednisolone, hydroxyurea or mycophenolate mofetil); phototherapy or photochemotherapy; high potency topical corticosteroids; “alternative medicine” treatments for psoriasis; or prolonged sun exposure or tanning bed use, which may in the opinion of the Investigator, modify disease activity. *Topical treatment within 2 weeks prior to commencement of study treatment and for the duration of the study, including: moderate potency topical corticosteroids; vitamin D analogues and topical retinoids; or keratolytics, coal tar and dithranol. *Have received any investigational research agent or therapeutic biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational Product. *Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product. *Have evidence of drug or alcohol abuse within 6 months prior to screening visit (i.e., more than fourteen units of alcohol per week [1 Unit equals to 150 mL of wine 360 mL of beer, or 45 mL of 40 % alcohol]). *Have clinical signs of active infection and/or a temperature of above 38.0 degree of C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator. *Anticipate surgery within the trial period or history of major surgery within 3 months of screening. *A depot injection or an implant of any drug within 3 months prior to administration of study treatment, with the exception of a contraceptive implant. *Participants who are unable to sign consent or unable to return for all scheduled study visits. *Evidence of current or previous clinically significant neurological, endocrinal, cardiovascular, pulmonary, haematological, malignant, immunologic, psychiatric, metabolic or other uncontrolled systemic disease, or finding of the medical examination (including vital signs and ECG), including any other condition that in the opinion of the investigator, would compromise the safety of the participant or interfere with assessment of endpoints or unsuitable for enrollment or impact on the quality of the data.
Outcome results
None listed