PHASE II CLINICAL TRIALS

Phase II trials investigate a drug in patients, rather than in the healthy subjects tested in Phase I trials. This phase continues to provide safety data as the number of people receiving the drug increases. However the focus of these studies is the efficacy of the drug, and the intention is to prove the hypothesis of how the drug works.

Phase II trials can be further divided into Phase IIa and Phase IIb studies. Phase IIa studies focus on proving the hypothesized mechanism of action – often called ‘proof-of-concept’ or ‘proof-of-mechanism’ studies – and tend to be with fewer numbers of patients than Phase IIb studies. Having confirmed the hypothesis, Phase IIb studies look to find the optimum dose at which the drug shows biological activity with minimal side-effects – often called ‘dose-ranging’ studies.

ACTELION'S PHASE II PORTFOLIO:

Compound Indication Study Status
Cenerimod Systemic lupus erythematosus Ongoing
Clazosentan  Reversal of vasospasm associated with aneurysmal subarachnoid hemorrhage  REVERSE Ongoing
Dual Orexin Receptor
Antagonist
 
Insomnia -   Ongoing 
Endothelin Receptor
Antagonist 
Specialty cardiovascular disorders  -   Ongoing
Macitentan CTEPH MERIT Complete
 

Physician, Global Drug Safety 

 

"I enjoy working for Actelion because every day we strive to make a difference in people's lives."