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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04056442
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stero Biotechs Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Steroid Dependent Crohn's Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: Cannabidiol

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

Placebo Comparator: Placebo

Olive Oil Solution

Interventions

Drug: - Cannabidiol , synthetic form

Cannabidiol ( synthetic form)

Drug: - Placebo

Olive Oil Solution, 5%

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Soroka Medical Center, Beer Sheva, Israel

Status

Recruiting

Address

Soroka Medical Center

Beer Sheva, ,

Site Contact

Doron Schwartz, Dr.

timna.naftali@clalit.org.il

97297471017

Meir Medical Center, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center

Kfar Saba, ,

Site Contact

Timna Naftali, Dr.

timna.naftali@clalit.org.il

97297471017

Shamir Medical Center, Tzrifin, Israel

Status

Recruiting

Address

Shamir Medical Center

Tzrifin, ,

Site Contact

Efrat Broide, Prof.

timna.naftali@clalit.org.il

97297471017

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.