A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients

Summary

Treatment will start with dose escalation in addition to Standard of Care (steroid therapy with or without additional therapies) . At the conclusion of the dose escalation segment of the study, if the 300 mg Cannabidiol dose level/placebo is deemed safe for two weeks with Standard of care dose of steroids, patients will continue receiving this 300 mg dose/placebo for an additional period of 3 months. Weekly tapering off of steroids will then commence and will be carried out . Three months after starting treatment with Cannabidiol an interim analysis to evaluate Cannabidiol's safety and efficacy will be carried out and treatment assignment group may be changed (according to response confirmation)

Timeline

Start

2019-07-07

Primary completion

2022-11-07

Completion

2022-11-07

Drugs

Indications

No indication recorded.