CompletedPhase 2ACTRN12616000922471

A safety and effectiveness of a gel containing 3% of active AKP-11 for pain and inflammation in arthritis participants.

A Phase I, Randomized, Placebo-Controlled, Double Blind, Trial of Safety, Tolerability and Efficacy Study of Topical AKP-11 Administration to Participants with Arthritis.

Sponsor

Akaal Pharma PTY LTD

Enrollment

20 participants

Start Date

Aug 1, 2016

Study Type

Interventional

Conditions

Gout

Summary

Arthritis is a disease that affects mainly the joints. Arthritis is a chronic, inflammatory disease characterized by swelling, tenderness and pain. AKP-11, is an experimental topical (applied to the skin) formulation being investigated for its potential as a treatment for arthritis. AKP-11 is anti-inflammatory drug candidate being developed for the treatment of arthritis, including gout, with mode of action targeting many pathological events at the same time.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria18

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.

Exclusion Criteria18

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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.