9 results
Primary:* To prove the superiority of a 48-weeks treatment with 3.2 g/day delayedreleasephosphatidylcholine (LT-02) versus placebo for the maintenance ofremission in patients with ulcerative colitis (UC)Secondary:* To study safety and tolerability…
Primary:• To prove the superiority of a 12-week add-on treatment with 3.2 g/daygastro-resistant phosphatidylcholine granules (LT-02) in at least one of twodifferent dosing regimens versus LT-02 placebo for the induction ofremission in patients with…
The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…
Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…
Primairy Objective* To test whether 5-ASA reduces the occurrence of colonic benign or malignant neoplasia compared to placebo in Lynch syndrome (LS) patients as detected by any colonoscopy until the end of study.Secondary Objectives* To test wheter…
Primary Objective: * To evaluate the haemostatic effect of N8-GP during surgical procedures in patients with haemophilia A. Secondary Objectives * To evaluate the general safety including immunogenicity of N8-GP when used for prevention and…
Main objective:Part 1: To determine the RP2D of abemaciclib that may be safely administered to patients with mCRPC in combination with abiaterone acetate and prednisone.Part 1&2&3:To compare the rPFS of patients receiving abiraterone…
The primary objective of Study I3Y-MC-JPBM is to compare treatment with LY2835219 plus NSAI therapy versus placebo plus NSAI therapy with respect to PFS in postmenopausal women with HR+, HER2- locoregionally recurrent or metastatic breast cancer who…
The primary objective is To evaluate the efficacy, in terms of invasive disease-free survival (IDFS), as defined by the STEEP System, for patients with HR+, HER2- early stage breast cancer for a dose of abemaciclib twice daily plus adjuvant…