Expected to Initiate in 1’Q 2022
Design
The ORCA-3 trial mirrors the Phase 3 ORCA-2 trial and is designed to obtain additional safety and efficacy data.
- Placebo-controlled & double-blind
- 3 treatment arms: Placebo vs 6 or 12 weeks cytisinicline
Cytisinicline treatment for 6 or 12 weeks
- Does longer treatment lead to better efficacy?
- Does continued treatment prevent early relapses?
- Primary Endpoint: 4-week continuous abstinence ON treatment
- Follow up to 6 months
