A Phase II Trial of Safety, Tolerability and Efficacy Study of Topical AKP-11 Administration to Participants with Arthritis.

Phase 2

Recruiting

• Conditions: Musculoskeletal - Osteoarthritis; arthritis treatment; rheumatoid arthritis treatment; osteoarthritis treatment; Gout treatment; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12617001223325
• Lead Sponsor: Akaal Pharma PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-22
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Males or females aged 18-75 years (inclusive) at the time of screening.
Primary complaint or clinical findings of osteoarthritis (PART A only).
Primary complaint or clinical findings of inflammatory arthritis (gout, osteoarthritis, rheumatoid arthritis) (PART B only).
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 equal or greater than 4 on a 11-point NRS (0 to 10) Scale over 3 days prior to randomization. All participants will need to score equal or greater than 4 on the 11 point NRS on Day 1
Baseline Swelling or Tenderness score of equal or greater than 1 prior to randomization.
Able to provide written informed consent prior to the performance of any study specific procedures.
BMI between 18.0 and 45.0 kg/m2, inclusive.
Female subjects of non-childbearing potential, defined as having a documented tubal ligation at least 6 weeks prior to dosing; having had a surgical bilateral oophorectomy (with or without hysterectomy); 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; 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; OR agree 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; 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 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, opiates, cannabinoids and benzodiazepines) result (urine test) at the time of screening. In participants on prescribed opioids, a positive screening test for opioids is allowed
Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule.

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 anti-inflammatory 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.
Have evidence of drug or alcohol abuse within 6 months prior to screening visits.
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: immunosuppressant agents (e.g. methotrexate, cyclosporine, azathioprine, thioguanine, prednisone, prednisolone, hydroxyurea or mycophenolate mofetil); biologics.
Topical treatment on the area to be studied within 2 weeks prior to commencement of study treatment and for the duration of the study, including: topical corticosteroids; topical NSAID 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 prior to baseline, or a live attenuated vaccine within 60 days prior to baseline, or intend to have a live vaccination during the course of the study (NB killed/inactive vaccines are allowed).
Have clinical signs of active infection and/or a temperature of greater than 38.0°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 S1P 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.
Any other condition that in the opinion of the investigator would render the subject unsuitable for enrolment, or could interfere with the subject participating in and completing the study or would put the participant at risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in pain score from baseline, using 11-point numerical pain rating scale.[Days 1, 7 and 14 in Part A<br>Days 1, 7, 14, 21 and 28 in Part B]

Secondary Outcome Measures

Name	Time	Method
Change in swelling and tenderness scores from baseline, as a composite outcome. The joint swelling will be assessed on site visits using a 4-point severity scale, where 0 is no swelling and 3 is severe swelling. The joint tenderness will be assessed on site visits using a 4-point severity scale, where 0 is no pain and 3 is severe pain, when touched.[Days 1, 7, 14 in Part A<br>Days 1, 7, 14, 21 and 28 in Part B];Change in AUSCAN or WOMAC score. The AUSCAN questionnaire consists of 15 items of daily activity and will be completed by participants who have arthritis on their hands, as a treatment area. The WOMAC questionnaire consists of 17 questions and will be completed by participants who have arthritis on their knee, as a treatment area. [Days 1, 7 and 14 in Part A<br>Days 1, 7, 14, 21 and 28 in Part B];Patient Global Assessment response to treatment (PGART)[Days 3, 7 and 14 in Part A<br>Days 3, 7, 14, 21 and 28 in Part B]