4 results
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…
The primary objective is to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children (ages 4-17 years, inclusive…
The primary objective of this study is to determine the safety, tolerability and efficacy of AR101 characterized oral desensitization immunotherapy (CODITTM) using alternative maintenance dosing intervals.The secondary objectives are:* To confirm…
OBJECTIVES - Phase 2 (not to be conducted in NL):Phase 2 Primary Objective:- Identify a setrusumab dosing strategy in subjects with OI Phase 2 Secondary Objectives:- Evaluate the PK of setrusumab doses in subjects with OI- Determine the PD effects…