5 results
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
The main goal of the proposed project is to compare two MTX dosing regimens to suppress ADA levels in patients with inflammatory bowel disease (IBD) with loss of response to anti-TNF agents, and to relate these findings to clinical and biochemical…
- To compare the pharmacokinetics (PK) of glepaglutide after a single subcutaneous (SC) administration by vial/syringe and by autoinjector.- To evaluate the safety and tolerability of glepaglutide following SC dosing in healthy subjects.
5.1 Primary ObjectiveTo confirm the efficacy of glepaglutide in reducing PS volume in SBS patients.5.2 Secondary ObjectivesTo evaluate the efficacy of glepaglutide on other efficacy endpoints in patients with SBS.To evaluate the safety and…
5.1 Primary ObjectiveTo evaluate the long-term safety of glepaglutide treatment in SBS patients.5.2 Secondary ObjectivesTo evaluate the long-term efficacy of glepaglutide treatment in SBS patients.To evaluate the long-term immunogenicity of…