The iMProveS trial is a 26 week, double blinded, randomized, placebo controlled phase IIa clinical study to investigate the safety, pharmacokinetics and efficacy of oral administration of two doses of odiparcil in patients 16 years and above with MPS type VI receiving enzyme replacement therapy (ERT). The study also has an open label arm with patients currently not on ERT. Enrollment has been completed for this trial.
During the trial patient’s GAG levels in the skin and white blood cells will be measured. Cardiac, pulmonary, ocular and audio function will be monitored and the mobility and pain of the patients assessed.
MPS type VI patients eligible to enroll must be
- 16 years of age or older
- Either currently receiving ERT or not have been on ERT for at least 3 months
- Patients can be located in any country but must be willing to travel to the trial sites
iMProveS is a European trial with study centers, the Royal Free Hospital in London (UK), Villa Metabolica in Mainz (Germany) and Hôpital Femme Mère Enfant in Lyon (France) and São João Hospital in Porto (Portugal) with the participation of Dr. Derralynn Hughes, Prof. Dr. Julia Hennermann, Dr. Nathalie Guffon and Dr. Elisa Leão-Teles. Please also visit https://clinicaltrials.gov/ct2/show/NCT03370653 for details of the trial.
Inventiva is preparing a phase Ib trial of odiparcil in MPS VI children >5 years old. The SAFE-KIDDS-MPS trial is expected to start recruitment in the last quarter of 2018. If you are interested in being kept informed about the progress please contact us.
Patient travel logistics are supported by MPS Commercial Ltd.
Patient associations can be found in almost all countries where people are effected by MPS. A reference to national MPS societies can be found on the web site of the MPS Society (UK)