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

June 29, 2020 updated by: Stero Biotechs Ltd.

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

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)

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Beer Sheva, Israel
        • Recruiting
        • Soroka Medical Center
        • Contact:
          • Doron Schwartz, Dr.
      • Kfar Saba, Israel
      • Tzrifin, Israel
        • Recruiting
        • Shamir medical center
        • Contact:
          • Efrat Broide, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cannabidiol
300 mg Cannabidiol (synthetic form) Olive Oil Solution, 5%
Cannabidiol ( synthetic form)
Olive Oil Solution, 5%
PLACEBO_COMPARATOR: Placebo
Olive Oil Solution
Olive Oil Solution, 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the safety and tolerability of up to 300 mg CBD/day measured by Adverse Events
Time Frame: 12 month
significance of the difference in percent of subjects experienced any Adverse events, drug-related Adverse events and Serious Adverse events between the study groups
12 month
Efficacy will be mesursed by precentegae of reduction in dose of steroids without flares
Time Frame: 12 month
50% reduction in dose of steroids without flares
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients without flares
Time Frame: 12 month
Disease flare will be recorded during the study
12 month
Percent of patients who did not demonstrate an increase in inflammatory activity
Time Frame: 12 month
inflammatory activity scored will be measured during the study
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 7, 2019

Primary Completion (ANTICIPATED)

July 7, 2021

Study Completion (ANTICIPATED)

July 7, 2021

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (ACTUAL)

August 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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