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

NCT04056442 | Completed Phase 2

• 1 other identifier: ST-SDCD-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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)

Conditions

Steroid Dependent Crohn's Disease

Outcome Measures

Primary Outcomes (2)

• 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

  12 month

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

  50% reduction in dose of steroids without flares

  12 month

Secondary Outcomes (2)

• Percentage of patients without flares

  12 month

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

  12 month

Study Arms (2)

Cannabidiol

EXPERIMENTAL

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

Drug: Cannabidiol , synthetic form; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Olive Oil Solution

Drug: Placebo

Interventions

Cannabidiol , synthetic form DRUG

Cannabidiol ( synthetic form)

Cannabidiol

Placebo DRUG

Olive Oil Solution, 5%

Cannabidiol; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stero Biotechs Ltd.: lead

Study Sites (3)

Soroka Medical Center

Beersheba, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Shamir Medical Center

Tzrifin, Israel

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 14, 2019
• Study Start: July 7, 2019
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)