Dose-escalation study of Baminercept in Secondary Progressive MS

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Blinded, Placebo-Controlled, Dose-Escalation Study to Evaluate the Penetration and Pharmacodynamic Effects of Baminercept in the CSF and Safety in Subjects with Secondary Progressive Multiple Sclerosis

• IRAS ID

  58768

• Contact name

  Raju Kapoor

• Sponsor organisation

  Biogen Idec Limited

• Eudract number

  2010-019555-22

• ISRCTN Number

  ISRCTN

• Research summary

  A PHASE 1B STUDY IN PARTICIPANTS WITH SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS (SPMS) TO DETERMINE WHETHER DOSE-ESCALATION OF BAMINERCEPT CAN LOWER LEVELS OF CEREBROSPINAfluD LYMPHOID TISSUE CHEMOKINES WHEN INJECTED SUBCUTANEOUSLY (SC) SPMS is a stage of the condition which comes after Relapsing Remitting MS (RRMS). Currently, most available MS therapies target only the relapsing and remitting form of the disease. In marked contrast, there are currently no safe and effective treatments for the secondary progressive form of the condition. The neurological damage may occur partly because of accumulations of cells of the immune system adjacent to the grey matter of the brain and this study is going to look at whether this process can be blocked by Baminercept. Baminercept is a drug which has been studied in the treatment of other autoimmune diseases such as Rheumatoid Arthritis, and may be able to lower levels of Central Nervous System (CNS) lymphoid tissue chemokines, which are responsible for this process, when injected SC in patients with SPMS. This study will take place in a number of hospitals around the world. The participants will be allocated to a treatment group by chance and neither the study doctor nor the participant will know which study treatment each participant's on. There will be 3 to 4 sequential treatment groups and the dose will be escalated from one group to the other. Enrolment into each subsequent cohort will not begin until safety data has been reviewed by the safety committee. Approximately 80 patients between the ages of 18 and 55 will be enrolled at 15 to 20 sites globally. In the UK the study will be conducted by Neurology Departments/ centres with MS services at NHS Hospitals. Patients that enrol in the study will be randomly assigned to one of 2 treatment arms (either Baminercept or Placebo) and will have a 75% chance of receiving Baminercept and a 25% chance of receiving placebo. Participants will be on the study for a total of 9 months, including a screening period of up to 4 weeks, 4 months of dosing, and 4 months of safety follow-up after the last dose. During that time they will undergo a series of tests and assessments, including blood and urine tests, physical and neurological examinations, brain MRI and lumbar punctures. The lumbar punctures are essential to determine if Baminercept administered with an injection under the skin reaches therapeutic concentrations in the nervous system and whether it affects immunological function significantly.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/67

• Date of REC Opinion

  7 Oct 2010

• REC opinion

  Favourable Opinion