Back to results

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

Primary Purpose

Steroid Dependent Crohn's Disease

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Cannabidiol , synthetic form

Placebo

About this trial

This is an interventional treatment trial for Steroid Dependent Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).
Age ≥18 years
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.
Patients will undergo an ECG and QT parameters will be measured for further analysis.
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.
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.
Subject able to provide written informed consent

Exclusion Criteria:

Viral Hepatitis (HAV, HBV, HCV)
HIV
Serious psychiatric or psychological disorders
Active consumption of illicit drugs including cannabis or derivatives for at least 3 months prior to the study
Patients with short bowel syndrome, symptomatic stricture, abscess, recent history (within the previous 3 months) of abdominal surgery, nutrient absorbance problems
Patients whose disease is inaccessible by endoscopy
Patients with significant cardiac, respiratory or active malignance disease (except Basel Cell Carcinoma) comorbidities.
Any uncontrolled infection at time of registration
Renal comorbidity: eGFR < 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2)
Patient who is taking immunomodulatory medications for other indication
Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding
-

Sites / Locations

Soroka Medical CenterRecruiting
Meir Medical CenterRecruiting
Shamir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cannabidiol

Placebo

Arm Description

300 mg Cannabidiol (synthetic form) Olive Oil Solution, 5%

Olive Oil Solution

Outcomes

Primary Outcome Measures

Assessment of the safety and tolerability of up to 300 mg CBD/day measured by Adverse Events

significance of the difference in percent of subjects experienced any Adverse events, drug-related Adverse events and Serious Adverse events between the study groups

Efficacy will be mesursed by precentegae of reduction in dose of steroids without flares

50% reduction in dose of steroids without flares

Secondary Outcome Measures

Percentage of patients without flares

Disease flare will be recorded during the study

Percent of patients who did not demonstrate an increase in inflammatory activity

inflammatory activity scored will be measured during the study

Full Information

NCT ID

NCT04056442

First Posted

August 13, 2019

Last Updated

June 29, 2020

Sponsor

Stero Biotechs Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04056442

Brief Title

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

Official Title

A Phase 2a, Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 7, 2019 (Actual)

Primary Completion Date

July 7, 2021 (Anticipated)

Study Completion Date

July 7, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stero Biotechs Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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)

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Steroid Dependent Crohn's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

Patients will be randomized at a 2:1 Cannabidiol:placebo ratio. After 3 month of treatment a blinded assessor will assess the patient response. Cannabidiol Non-responders will be removed from the trial, and Placebo Non-responders will be switched over to Cannabidiol

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cannabidiol

Arm Type

Experimental

Arm Description

300 mg Cannabidiol (synthetic form) Olive Oil Solution, 5%

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Olive Oil Solution

Intervention Type

Drug

Intervention Name(s)

Cannabidiol , synthetic form

Intervention Description

Cannabidiol ( synthetic form)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Olive Oil Solution, 5%

Primary Outcome Measure Information:

Title

Assessment of the safety and tolerability of up to 300 mg CBD/day measured by Adverse Events

Description

significance of the difference in percent of subjects experienced any Adverse events, drug-related Adverse events and Serious Adverse events between the study groups

Time Frame

12 month

Title

Efficacy will be mesursed by precentegae of reduction in dose of steroids without flares

Description

50% reduction in dose of steroids without flares

Time Frame

12 month

Secondary Outcome Measure Information:

Title

Percentage of patients without flares

Description

Disease flare will be recorded during the study

Time Frame

12 month

Title

Percent of patients who did not demonstrate an increase in inflammatory activity

Description

inflammatory activity scored will be measured during the study

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Age ≥18 years 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. Patients will undergo an ECG and QT parameters will be measured for further analysis. 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. 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. Subject able to provide written informed consent Exclusion Criteria: Viral Hepatitis (HAV, HBV, HCV) HIV Serious psychiatric or psychological disorders Active consumption of illicit drugs including cannabis or derivatives for at least 3 months prior to the study Patients with short bowel syndrome, symptomatic stricture, abscess, recent history (within the previous 3 months) of abdominal surgery, nutrient absorbance problems Patients whose disease is inaccessible by endoscopy Patients with significant cardiac, respiratory or active malignance disease (except Basel Cell Carcinoma) comorbidities. Any uncontrolled infection at time of registration Renal comorbidity: eGFR < 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2) Patient who is taking immunomodulatory medications for other indication Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Timna Naftali, Dr.

Phone

97297471017

timna.naftali@clalit.org.il

Facility Information:

Facility Name

Soroka Medical Center

City

Beer Sheva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Doron Schwartz, Dr.

Facility Name

Meir Medical Center

City

Kfar Saba

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timna Naftali, Dr.

Phone

97297471017

timna.naftali@clalit.org.il

Facility Name

Shamir Medical Center

City

Tzrifin

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Efrat Broide, Prof.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs