A safety and effectiveness of a gel containing 3% of active AKP-11 for pain and inflammation in arthritis participants.
- Conditions
- arthritisGoutInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12616000922471
- Lead Sponsor
- Akaal Pharma PTY LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[Baseline, Day 3, 7 & 14];Change in Patient Global Assessment of Response to<br>Treatment (PGART) from baseline[Baseline, Day 3, 7 & 14];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.<br>[Baseline, Day 1, 7 & 14 ]
- Secondary Outcome Measures
Name Time Method 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).[Baseline, Day 3, 7, & 14];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).[Baseline, Day 3, 7 & 14]