Ph III trial of Nitec's Lodotra completes recruitment
Nitec Pharma AG, a Swiss specialty drug developer, has finalized recruitment for the second pivotal Phase III trial of its lead product, Lodotra (prednisone), its modified-release tablet developed to optimize the efficacy of an orally-administered low dose of the steroid.
The CAPRA-2 study will evaluate the safety and efficacy of the agent in the treatment of the signs and symptoms of rheumatoid arthritis, a chronic, progressive and disabling autoimmune disorder.
The data will be used to file for US marketing approval together with the data already available from the CAPRA-1 first pivotal Phase III trial.
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