Safety study of ATX-MS-1467 in relapsing multiple sclerosis

• Research type

  Research Study

• Full title

  Safety and proof of principle study of ATX-MS-1467 in patients with Relapsing Multiple Sclerosis: Open label upward titration over five dose levels and using two routes of administration (intradermal and subcutaneous)

• IRAS ID

  36319

• Contact name

  Jeremy Chataway

• Sponsor organisation

  APITOPE TECHNOLOGY (BRISTOL) LTD

• Eudract number

  2009-016710-25

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Multiple Sclerosis (MS) is the most common neurological disorder among people aged 20 to 40 years old. It is a chronic degenerative disease of the central nervous system in which gradual destruction of a substance called myelin occurs in patches throughout the brain and/ or spinal cord. This causes muscle weakness, loss of coordination and speech and visual disturbances. It is generally accepted that MS is an autoimmune disease where the body??s immune system reacts to the body itself. Current therapies for autoimmune diseases are based on treatments that non-specifically suppress the patient??s immune system. These therapies are associated with a wide range of complications and side effects. This open-label phase I study will be conducted in hospitals and will use ATX-MS-1467, which is a type of investigational drug being developed to make the body??s immune system tolerate the body again, without suppressing the whole immune system. The study will assess whether ATX-MS-1467 is safe and tolerated when taken by 40 patients who are affected by relapsing forms of MS. The effect of the medication on the immune system will also be tested by MRI scanning. There is a screening period of up to 8 weeks followed by a treatment period of 16 weeks. There will be two groups of patients (cohort 1 and 2), each consisting of 20 patients. There will be an upward titration over four dose levels (injections of 25, 50, 100 and 400 æg) of ATX-MS-1467 followed by five injections of 800 æg. All injections will be administered either intradermally (between the layers of the skin) (cohort 1) or subcutaneously (under the skin) (cohort 2) at intervals of 14 3 days. There is also a follow up period lasting a total 32 weeks including 4 visits to the clinic.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/112

• Date of REC Opinion

  11 Feb 2010

• REC opinion

  Further Information Favourable Opinion