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
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
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)
Individual patient Standard of Care (steroid therapy with or without additional therapies)
 will be administered in a stable fashion during the first weeks of the study in addition to
 increasing doses of Cannabidiol or placebo ( in a double blind manner. Dosage of Cannabidiol
 will start at 25 mg twice a day and will be increased every two days, if no side effects are
 observed, to 50 mg twice a day, 100 mg twice a day and finally to 150 mg twice a day
 Cannabidiol respectively. Treatment will be given with food. Identical placebo will be
 administered in the placebo arm. In stage 1,both patient and investigator will be blinded to
 treatment modalities.

 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 by an independent assessor not
 associated with the study .At the conclusion of this interim analysis, Cannabidiol
 Non-responders will be removed from the trial, and Placebo Non-responders will be switched
 over to Cannabidiol.

 If a patient flares, then his/her code will be opened by the unblinded observer. If the
 subject has been administered placebo, then he/she will be crossed over to the Cannabidiol
 arm. If the subject has been administered Cannabidiol, then he/she will be restarted on
 Standard of care prednisone in addition to Cannabidiol or removed from study, depending on
 the severity of the flare-up.
Inclusion Criteria:

 1. Patients with biopsy confirmed, active, steroid dependent CD, without nutrient
 absorbance problems (Definition of steroid dependency: CD being treated with at least
 5 mg/day steroids for the last 3 months; an attempt to reduce the dose induces flare
 of disease as determined by physician assessment).

 2. Age ≥18 years

 3. Steroid treatment of at least 3 months and stable steroid dose for at least 2 weeks
 .If thiopurines and/or biologics are also being administered, then must be
 administered at stable dose(s) for at least 3 months.

 4. Patients will undergo an ECG and QT parameters will be measured for further analysis.

 5. Female subjects who are postmenopausal (absence of menses for ≥ 2 years confirmed by a
 follicle stimulating hormone test), or who are surgically sterilized may be enrolled.
 Similarly, women of childbearing potential who had a negative pregnancy test at
 screening, who are willing to use two medically acceptable methods of contraception
 for the duration of the study as well as for at least three months after cessation of
 CBD treatment and who are willing to undergo pregnancy testing according to the study
 protocol may be enrolled.

 6. Female subjects who are not breast-feeding and who have no intention to breast-feed
 during the term of the trial and for at least three months after cessation of CBD
 treatment may be enrolled.

 7. Subject able to provide written informed consent

 Exclusion Criteria:

 1. Viral Hepatitis (HAV, HBV, HCV)

 2. HIV

 3. Serious psychiatric or psychological disorders

 4. Active consumption of illicit drugs including cannabis or derivatives for at least 3
 months prior to the study

 5. Patients with short bowel syndrome, symptomatic stricture, abscess, recent history
 (within the previous 3 months) of abdominal surgery, nutrient absorbance problems

 6. Patients whose disease is inaccessible by endoscopy

 7. Patients with significant cardiac, respiratory or active malignance disease (except
 Basel Cell Carcinoma) comorbidities.

 8. Any uncontrolled infection at time of registration

 9. Renal comorbidity: eGFR < 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR
 15-29 mL/min/1.73 m2)

 10. Patient who is taking immunomodulatory medications for other indication

 11. Women of child-bearing potential who intend to become pregnant or who are pregnant or
 breastfeeding

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