Clinical Research Studies

Site for The study will consist of 12 months, open-label, multi-center, randomized, active controlled, parallel group study comparing efficacy and safety of weekly MOD-4023 to daily GH, Genotropin®. Both drugs will be injected using a PEN device. The study will be divided into two parts: Main Study Period (main study): After an 8 wk screening period, patients meeting the eligibility criteria, as approved by global study MM, will be randomized in a 1:1 ratio to weekly SC doses of MOD-4023 (investigational treatment) or daily SC administration of Genotropin® (reference therapy) for 12 months. The key safety data will be reviewed by an independent DSMB every 4 months or on an ad hoc basis. LT-OLE Period (LT-OLE): Patients who received MOD-4023 during the main study will continue in the LT-OLE with the same dose (mg/kg/wk) of MOD-4023. Patients who received Genotropin® during the main study will be switched to MOD-4023 and will begin treatment with a dose of 0.66 mg/kg/wk beginning no less than one day after cessation of Genotropin® treatment. The key safety data will be reviewed by an independent DSMB approximately every 6 months. During the entire study (main study and LT-OLE), the dose of MOD-4023 and Genotropin® will be adjusted every 3 months based on the patient’s body weight. Doses may be decreased for safety reasons according to the pre-defined dose adjustment criteria (which will be based on the severity of AEs or repeated, elevated levels of IGF-1). The dose will be decreased based on two, repeated day 4(-1) post-dose levels of IGF-1 SDS = +2.0 (Section 6.4). During the LT-OLE, dose reduction for IGF-1 level >+2.0 SDS will be made following consultation with the Global Study MM on an individual patient basis. The total duration of patient participation in the main study will be up to 15 months (12 months of treatment, up to eighta (+4) wks of screening and one month post dosing EOS follow up for patients not continuing in the LT-OLE, discontinued early or following study closure). The LT-OLE will continue until marketing approval. The study will be conducted at approximately 200 sites in 30-40 countries worldwide.