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Trial registered on ANZCTR


Registration number
ACTRN12616000922471
Ethics application status
Approved
Date submitted
6/07/2016
Date registered
12/07/2016
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A safety and effectiveness of a gel containing 3% of active AKP-11 for pain and inflammation in arthritis participants.
Scientific title
A Phase I, Randomized, Placebo-Controlled, Double Blind, Trial of Safety, Tolerability
and Efficacy Study of Topical AKP-11 Administration to Participants with Arthritis.
Secondary ID [1] 289625 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
arthritis 299409 0
Gout 299443 0
Condition category
Condition code
Inflammatory and Immune System 299389 299389 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A four times daily topical application (0.5 g per application) of 2 g gel containing 60 mg of active AKP-11 on affected joints for 7 days to arthritis patients. An adherence will be monitored by used and unused sachets return.
Intervention code [1] 295237 0
Treatment: Drugs
Comparator / control treatment
This is a placebo-controlled double blind study. The placebo is a gel without active drug. It has the same appearance and smell as an active gel.
Control group
Placebo

Outcomes
Primary outcome [1] 298855 0
Safety of AKP-11 gel. The safety endpoints are; adverse events (AEs). physical examination. vital signs, ECG, laboratory assessment (haematology, biochemistry, and urinalysis), an application site irritation assessment. An AEs can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptoms such as skin irritation, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Timepoint [1] 298855 0
Baseline, Day 3, 7 & 14
Primary outcome [2] 298856 0
Change in Patient Global Assessment of Response to
Treatment (PGART) from baseline
Timepoint [2] 298856 0
Baseline, Day 3, 7 & 14
Primary outcome [3] 298857 0
Change in pain score from baseline. The pain severity score represents a daily self-assessment by each participant of the severity of pain in 11-Point Numerical Pain Rating Scale during the previous 24 h in the participant diaries. Participant will also be asked to complete a Pain Self Efficacy Questionnaire (PSEQ) at each visit.
Timepoint [3] 298857 0
Baseline, Day 1, 7 & 14
Secondary outcome [1] 325454 0
Change in swelling score from baseline, using four point severity scale, where Score 0 refers to No swelling and Score 3 refers to severe swelling (bulging beyond joint margins).
Timepoint [1] 325454 0
Baseline, Day 3, 7, & 14
Secondary outcome [2] 325455 0
Change in tenderness score from baseline, using four point severity scale, where Score 0 refers to No pain and Score 3 refers to Severe (patient states there is pain, winces and withdraws).
Timepoint [2] 325455 0
Baseline, Day 3, 7 & 14

Eligibility
Key inclusion criteria
Males or females aged 18-65 years (inclusive) at the time of screening.
Primary complaint or clinical findings of inflammatory arthritis, specifically rheumatoid arthritis or gout.
Stable disease in both extent and severity for at least two weeks prior to the commencement of study treatment.
An average baseline pain score of greater than 4 on a 11-point NRS (0 to 10) Scale over 3 days prior to randomization.
Baseline Swelling or Tenderness score 1 prior to randomization.
Able to provide written informed consent prior to the performance of any study specific procedures.
BMI between 18.0 and 40.0 kg/m2, inclusive.
Female subjects of non-childbearing potential, defined as (1) having a documented tubal ligation at least 6 weeks prior to dosing; (2) having had a surgical bilateral oophorectomy (with or without hysterectomy); (3) at least 12 months of spontaneous amenorrhoea with follicle stimulating hormone (FSH) greater than 40 MIU/ml.
Female participants of child-bearing potential with negative urine pregnancy test at screening and negative urine pregnancy test at check-in (Day 1), AND; a. Agree 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; b. OR agree to use condoms plus one other acceptable form of contraception; i.e. intrauterine device, hormonal contraception (oral,injected or implanted) or a female diaphragm,from screening until 4 weeks after dosing with study drug;
c. OR has only same-sex partners; d. OR has a vasectomized partner, which should
be the sole partner for that participant.
Male participants with female partners of childbearing potential must agree to abstinence if this is in line with the usual lifestyle, 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, cannabinoids and benzodiazepines) result (urine test) at the time of
screening.
A 12-lead ECG at screening that in the opinion of the investigator, has no abnormalities that compromise subject’s safety in this study.
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations.
Current treatment with immunosuppressant agents or systemic corticosteroids.
Expected change in existing analgesia, and antiinflammatory therapy.
Recent history of major joint injury or surgery.
Major chronic inflammatory disease (e.g Crohn’s disease, SLE) excluding rheumatoid arthritis,
Congenital or acquired immunodeficiency or cancer prone syndrome.
History of malignancy (other than adequately treated skin carcinoma or carcinoma-in-situ of the cervix).
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);
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.
Have clinical signs of active infection and/or a temperature of greater than 38.0 degrees 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.
History of hypersensitivity to any other S1P1 receptor modulator.
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 return for all scheduled study visits.
Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, haematological, malignant, immunologic, psychiatric, metabolic or other uncontrolled systemic disease, with the exclusion of arthritis.
Any clinically significant abnormality at screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and an 12-lead- ECG.

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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
1/08/2016
Date of last participant enrolment
Anticipated
15/12/2016
Actual
15/12/2016
Date of last data collection
Anticipated
30/12/2016
Actual
30/12/2016
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294011 0
Commercial sector/Industry
Name [1] 294011 0
Akaal Pharma PTY LTD
Country [1] 294011 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Akaal Pharma PTY LTD
Address
Chemistry Department
Thomas Cherry Building # 301 E
La Trobe University
Bundoora, VIC - 3086
Country
Australia
Secondary sponsor category [1] 292831 0
None
Name [1] 292831 0
Address [1] 292831 0
Country [1] 292831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295422 0
Central Adelaide Local Health Network (CALHN) Research Ethics
Ethics committee address [1] 295422 0
Ethics committee country [1] 295422 0
Australia
Date submitted for ethics approval [1] 295422 0
05/06/2016
Approval date [1] 295422 0
01/07/2016
Ethics approval number [1] 295422 0
R20160605

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67226 0
Prof Guy Ludbrook
Address 67226 0
University of Adelaide and Royal Adelaide Hospital
North Terrace, Adelaide; South Australia 5000
Country 67226 0
Australia
Phone 67226 0
+61 8 8222 5422
Fax 67226 0
Email 67226 0
Guy.Ludbrook@sa.gov.au
Contact person for public queries
Name 67227 0
Gurmit Gill
Address 67227 0
Akaal Pharma Pty Ltd
Chemistry Department
Thomas Cherry Building # 301 E
La Trobe University
Bundoora, VIC - 3086
Country 67227 0
Australia
Phone 67227 0
+613-9479-2584
Fax 67227 0
Email 67227 0
Gurmit.Gill@latrobe.edu.au
Contact person for scientific queries
Name 67228 0
Gurmit Gill
Address 67228 0
Akaal Pharma Pty Ltd
Chemistry Department
Thomas Cherry Building # 301 E
La Trobe University
Bundoora, VIC - 3086
Country 67228 0
Australia
Phone 67228 0
+613-9479-2584
Fax 67228 0
Email 67228 0
gurmit.gill@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.