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CompletedNCT04056442Updated Apr 17, 2024

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 2 interventional study of Cannabidiol , synthetic form and Placebo in Steroid Dependent Crohn's Disease, sponsored by Stero Biotechs Ltd.. Completed at 3 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Stero Biotechs Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Steroid Dependent Crohn's Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 15 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Stero Biotechs Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

    -

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Cannabidiol

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

    Drug: Cannabidiol , synthetic form · Drug: Placebo

  • Placebo comparator
    Placebo

    Olive Oil Solution

    Drug: Placebo

Interventions

  • DrugCannabidiol , synthetic form

    Cannabidiol ( synthetic form)

  • DrugPlacebo

    Olive Oil Solution, 5%

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 month

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

    50% reduction in dose of steroids without flares

    Time frame: 12 month

Secondary outcomes

  1. Percentage of patients without flares

    Disease flare will be recorded during the study

    Time frame: 12 month

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

    inflammatory activity scored will be measured during the study

    Time frame: 12 month

07

Study locations

3 sites
  • Soroka Medical Center
    Beer Sheva, Israel
  • Meir Medical Center
    Kfar Saba, Israel
  • Shamir Medical Center
    Tzrifin, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04056442
Lead sponsor
Stero Biotechs Ltd.
Responsible party
Sponsor
First posted
Aug 14, 2019
Start date
Jul 7, 2019
Primary completion
Nov 7, 2022
Completion
Nov 7, 2022
Last update
Apr 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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