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Trial registered on ANZCTR


Registration number
ACTRN12616000293460
Ethics application status
Approved
Date submitted
24/09/2015
Date registered
7/03/2016
Date last updated
2/07/2019
Date data sharing statement initially provided
2/07/2019
Date results information initially provided
2/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety,tolerability and efficacy of topical AKP-11 for plaque psoriasis
Scientific title
A Phase II, randomised, double-blind, placebo-controlled study of the safety, tolerability and efficacy of topical AKP-11 administration to participants with plaque psoriasis.
Secondary ID [1] 287538 0
CT-2015-CTN-01566-1 v2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory skin condition 296305 0
Plaque psoriasis 296306 0
Condition category
Condition code
Skin 296583 296583 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 292938 0
Treatment: Drugs
Comparator / control treatment
Placebo; the identically looking ointment formulation without without active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 296196 0
Safety and tolerability of AKP-11 will be assessed by monitoring adverse events, vital signs, physical examination, ECG, laboratory variables (haematology, chemistry, urinalysis) and skin irritation assessment using 8 point severity scale.
Timepoint [1] 296196 0
Timepoints: Day 1, 8, 15, 29 and 43 and End of Study Visit (EOS); 7 days after the last treatment.
Primary outcome [2] 297576 0
Change in local physician global assessment (L-PGA) from baseline, using 8-point severity scale.
Timepoint [2] 297576 0
Day 1, 8, 15, 29, 43, EOS
Primary outcome [3] 297578 0
Change in Target Plaque Severity Score (TPSS) from baseline using 5-points severity scale.
Timepoint [3] 297578 0
Day 1, 8, 15, 29, 43 and EOS
Secondary outcome [1] 317788 0
Change in Target Plaque Area (TPA), using the photos images and tracking the plaque area/s.
Timepoint [1] 317788 0
Timepoints: Day 1, 15, 29 and 43.
Secondary outcome [2] 321434 0
Change in pruritus score, using Visual Analogue Scale (VAS).
Timepoint [2] 321434 0
Day 1, 8, 15,29, 43 and EOS at the clinical sites and daily on a diary card, using self-assessment on 10-cm horizontal VAS scale,being informed that the beginning of the scale refers to no pruritus (0 points) and the end to the most severe pruritus they can imagine (10 points).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who meet the inclusion/exclusion criteria will be assigned a randomization number in the order of final eligibility for entry into the study using a randomization schedule generated prior to the start of the study. Participants will be randomly assigned to receive either AKP-11 or placebo treatment. As this is a double-blind, placebo controlled study, both the study personnel and participants will be blinded as to which treatment they are to receive. Dispensed investigational product will be identified by the randomisation number. No labelling will be included that could cause blind leakage.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This study was terminated as Akaal Pharma (Sponsor) licensed out the program to Pharmaceutical Company in USA to conduct further development.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 292104 0
Commercial sector/Industry
Name [1] 292104 0
Akaal Pharma Pty Ltd
Address [1] 292104 0
Chemistry Department, PS-3 #309-10
Plenty Rd, La Trobe University, Bundoora, VIC - 3086
Country [1] 292104 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Akaal Pharma Pty Ltd
Address
Chemistry Department, PS-3 #309-10
Plenty Rd, La Trobe University, Bundoora, VIC - 3086
Country
Australia
Secondary sponsor category [1] 290781 0
None
Name [1] 290781 0
Address [1] 290781 0
Country [1] 290781 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293592 0
Bellberry Limited
Ethics committee address [1] 293592 0
Bellbery Human Research Ethics
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 293592 0
Australia
Date submitted for ethics approval [1] 293592 0
Approval date [1] 293592 0
11/09/2015
Ethics approval number [1] 293592 0

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60586 0
Prof Pablo Fernandez-Penas
Address 60586 0
Skin and Cancer Foundation Australia
7 Ashley Lane, Westmead, NSW 2145
Country 60586 0
Australia
Phone 60586 0
+6129845 9767
Fax 60586 0
Email 60586 0
pablo.fernandezpenas@sydney.edu.au
Contact person for public queries
Name 60587 0
Prof Peter Foley
Address 60587 0
Skin and Cancer Foundation Inc.
Level 1, 80 Drummond St, Carlton,
VIC - 3053
Country 60587 0
Australia
Phone 60587 0
+61396239400
Fax 60587 0
Email 60587 0
pfoley@skincancer.asn.au
Contact person for scientific queries
Name 60588 0
Dr Gurmit S Gill
Address 60588 0
Chemistry Department, PS3, #309-10, La Trobe University, Bundoora, VIC -3086
Country 60588 0
Australia
Phone 60588 0
+61394792584
Fax 60588 0
Email 60588 0
Gurmit.Gill@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary