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

Exclusion Criteria19

• 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.