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Trial registered on ANZCTR


Registration number
ACTRN12616000294459
Ethics application status
Approved
Date submitted
1/03/2016
Date registered
7/03/2016
Date last updated
9/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and efficacy of AKP-11 for atopic dermatitis.
Scientific title
A Phase I, safety, tolerability and efficacy study of topical AKP-11 administration to participants with atopic dermatitis.
Secondary ID [1] 288662 0
None
Universal Trial Number (UTN)
U1111-1180-2112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 297848 0
Condition category
Condition code
Skin 298022 298022 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves the twice daily topical application of 1 g ointment containing 30 mg of active AKP-11 or matching placebo to participants with atopic dermatitis for 4 weeks or one week post complete clearance, confirmed by the physician, whichever comes first when the AKP-11 or placebo ointment will be applied twice daily. The target area of up to 300 cm2 (~1.5 % of BSA). will be selected by investigator. At every visit, the participant will have to to return used and unused sachets to the study personal for accountability purposes. Participants will be randomized as groups of 2 (AKP-11) and 1 (Placebo).
Intervention code [1] 294076 0
Treatment: Drugs
Comparator / control treatment
Placebo ointment without active AKP-11.
Control group
Placebo

Outcomes
Primary outcome [1] 297536 0
Safety of 3% AKP-11 ointment. This is assessed by drug related adverse events, physical examination, vital signs, ECG, laboratory assessment (haematology, plasma biochemistry, and urinalysis) and skin irritation assessment, as reported by investigator and by participant in study diary.
Timepoint [1] 297536 0
Day 1, 8, 15, 22, 28 and End of Study (EOS) visit (Day 7 post last treatment day)
Primary outcome [2] 297537 0
Change in Local-Investigator Global assessment (L-IGA) from baseline using 6-point scale.
Timepoint [2] 297537 0
Day 1, 8, 15, 22, 28 and EOS
Primary outcome [3] 297538 0
Change in Local Eczema Area and Severity Index (L-EASI) score from the baseline, using a 4-point severity scale.
Timepoint [3] 297538 0
Day 1, 8, 15, 22, 28 and EOS
Secondary outcome [1] 321345 0
Change in Eczema Area and Severity Index (EASI) score from baseline.
Timepoint [1] 321345 0
Day 1 and 28
Secondary outcome [2] 321346 0
Change in severity of atopic dermatitis, as assessed by SCORAD.
Timepoint [2] 321346 0
Day 1, 8, 15, 22, 28 and EOS
Secondary outcome [3] 321347 0
Change in pruritus score. The participant diaries will be provided to the participants that include the details how to score pruritus. Participant need to mark a line on a horizontal 10 cm long VAS scale. The study personnel will advise the participants how to mark the VAS scale during the Day 1 visit and ensure the participants are correctly marking VAS scale at every site visit. The participants will refer the table and imagine the intensity of pruritus they experience.
Timepoint [3] 321347 0
Day 1, 8, 22, 28 and EOS

Eligibility
Key inclusion criteria
*Males or females aged 18-65 years (inclusive) at the time of screening.
*Individuals diagnosed with atopic dermatitis according to the criteria of Hanifin and Rajka.
*Individuals with mild to moderate disease and equal to 10 % of BSA with atopic dermatitis.
*Participants with L-EASI score of equal to 1 for each of the signs at an appropriate target site.
*Able to provide written informed consent proper 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 and preferred lifestyle;
*OR agrees to use condoms plus one other acceptable form of contraception; i.e. intra-uterine device, hormonal contraception (oral, injected or implanted) 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, which should be the sole partner for that participant.
*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 such as oral, injected or implanted; or male condom plus female diaphragm or cervical cap) 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.
*Negative drug screening test (drugs of abuse; Creatinine control, testing for amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines) result (urine test) 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
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Participants with any skin condition other than atopic dermatitis in particular cutaneous infections, significant sun damage or an inherited skin disorder that in the opinion of the Investigator could interfere with the evaluation of the trial medication.
*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; or sun exposure or tanning bed use, or any other therapy that in the opinion of the investigator could 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; topical retinoids; or keratolytics, coal tar and dithranol or any other topical that in the opinion of the investigator could modify disease activity.
*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 = 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 degrees 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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
Recruitment hospital [1] 5949 0
Skin and Cancer Foundation Australia (Westmead) - Westmead

Funding & Sponsors
Funding source category [1] 293020 0
Commercial sector/Industry
Name [1] 293020 0
Akaal Pharma PTY LTD
Address [1] 293020 0
Room 301 E&F
Thomas Cherry Building
Chemistry Department
La Trobe University,
Bundoora, VIC 3086
Country [1] 293020 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Akaal Pharma PTY LTD
Address
Room 301 E&F
Thomas Cherry Building
Chemistry Department
La Trobe University,
Bundoora, VIC 3086
Country
Australia
Secondary sponsor category [1] 291796 0
None
Name [1] 291796 0
Address [1] 291796 0
Country [1] 291796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294530 0
Bellberry Limited
Ethics committee address [1] 294530 0
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 294530 0
Australia
Date submitted for ethics approval [1] 294530 0
25/11/2015
Approval date [1] 294530 0
22/02/2016
Ethics approval number [1] 294530 0
2015-10-711

Summary
Brief summary
This is a Phase I study to determine the safety, tolerability and efficacy of topical doses of AKP-11 when administered to participants with atopic dermatitis. 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 in order to establish its efficacy. The twice daily topical application of 1 g ointment containing 30 mg AKP-11 or matching placebo in up to 21 participants. Participants will be randomized as groups of 2 (AKP-11) and 1 (Placebo). The dosing is proposed for up to 28 days or one week post complete clearance, confirmed by the physician, whichever comes first.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64022 0
A/Prof Peter Foley
Address 64022 0
Skin & Cancer Foundation
Level 1, 80 Drummond Street
Carlton VIC 3053
Country 64022 0
Australia
Phone 64022 0
+61396239400
Fax 64022 0
Email 64022 0
pfoley@skincancer.asn.au
Contact person for public queries
Name 64023 0
A/Prof Peter Foley
Address 64023 0
Skin & Cancer Foundation
Level 1, 80 Drummond Street
Carlton VIC 3053
Country 64023 0
Australia
Phone 64023 0
+61396239400
Fax 64023 0
Email 64023 0
pfoley@skincancer.asn.au
Contact person for scientific queries
Name 64024 0
Dr Gurmit Gill
Address 64024 0
Akaal Pharma PTY LTD
Room 301 E&F
Thomas Cherry Building
Chemistry Department
La Trobe University,
Bundoora, VIC 3086
Country 64024 0
Australia
Phone 64024 0
+61394792584
Fax 64024 0
Email 64024 0
gurmit.gill@latrobe.edu.au

No information has been provided regarding IPD availability
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