Phase IB Study to Evaluate Safety and Pharmacokinetics of MOR103 in MS

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled Phase 1B Study to Evaluate the Safety and Pharmacokinetics of MOR103, A Human Antibody to GM-CSF, in Patients with Mutliple Sclerosis

• IRAS ID

  81289

• Contact name

  Cris Constantinescu

• Sponsor organisation

  MorphoSys AG

• Eudract number

  2011-001064-22

• ISRCTN Number

  n/a

• Research summary

  This study is a multicentre, randomized, double-blind, placebo-controlled, Phase Ib study to evaluate the safety and pharmacokinetics of multiple doses of the study drug MOR103. This means that it will be conducted in several study sites in several countries (UK, Germany and Poland), the treatment allocation will be done by chance (randomized), neither the subject nor the study doctor will know what treatment the subject will be receiving (double-blind) and some of the participants in the study will receive a dummy drug (placebo-controlled) which contains no active substance in it, compared to the investigational drug (MOR103). ??Phase Ib? means that the study drug will be administered for the first time in patients having Multiple Sclerosis (MS). MOR103 is a recombinant human monoclonal antibody targeting a substance (called GM-CSF for granulocyte macrophage colony stimulating factor) which enhances the activity of various inflammation cells. By binding to the substance GM-CSF, MOR103 may inhibit some of the inflammation mechanisms, as it is believed that inflammation is an important pathway for the development and exacerbations of MS. MOR103 will be administered to patients in a continuous intravenous infusion over a period of 60 minutes. Patients will be in 3 cohorts and will receive a total of 6 doses throughout the course of the study if they meet all inclusion/exclusion criteria. Patients will visit the clinic/facility approximately every two weeks. The maximum duration for each patient in the study will be 165 days.Safety and Pharmacokinetics assessments will involve the following procedures: taking blood samples, electrocardiogram, MRI scans and pulmonary lung function testing.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/YH/0337

• Date of REC Opinion

  7 Oct 2011

• REC opinion

  Further Information Favourable Opinion