A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase 2b Trial of Cytisinicline in Adult Smokers

ORCA-12019-06-11T12:59:51+00:00

Positive Phase 2b ORCA-1 Results Reported

ORCA-1

This Phase 2b trial was conducted in the US to assess various dosing schedules of cytisinicline in approximately 254 smokers. It evaluated efficacy based on the overall reduction in the number of cigarettes smoked during the various study treatment doses and schedules. It also evaluated compliance and safety profiles, compared to the respective placebo arms. This dose-finding study resulted in identification of the 3 mg, 3 times daily dosing regimen to be used in future cytisinicline Phase 3 trials.

ORCA-1

ORCA-1 Program Infographic. Click image to enlarge.

Study Design

This six-arm, multi-center, double-blind, randomized, placebo-controlled, Phase 2b study was conducted in the US. The study was double-blinded to dose but not to the administration schedule. Subjects provided a quit date 5-7 days from randomization. Study treatment started the day after randomization such that study treatment was initiated prior to the quit date.

Demographics were similar between schedules and for treatment arms in gender, age, years of prior smoking, and number of previous quit attempts. At baseline, subjects in the study reported smoking a median of 20 cigarettes per day. ORCA-1 was initiated in October 2018 and enrolled 254 smokers at eight centers across the United States.

ORCA-1 Trial Locations

ORCA-1 was conducted at the following locations in the US.

AL AK AZ AR CA CO CT DE FL GA HI ID IL IN IA KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WI WY DC

ORCA-1 Program Study Design. Click image to enlarge.

Central Kentucky Research
www.ckraresearch.com

Volunteer Research Group
www.volresearch.com

Center for Pharmaceutical Research
http://www.cprkc.com

FutureSearch Trials of Dallas
www.fstrials.com

Coastal Carolina Research Center in North Charleston
www.coastalcarolinaresearch.com

Rochester Clinical Research, Inc.
www.rcrclinical.com

Clinical Research Consortium
www.crctrials.com