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Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

Primary Purpose

Chronic Spontaneous Urticaria

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

CBD

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria

Eligibility Criteria

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

Inclusion Criteria:

Patients with active CSU for at least 4 months which was treated with anti-histamines as well as at least one course of steroids (ex. Prednisone)
Age ≥18 years
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
Other chronic dermatological conditions under active treatment
Active consumption of illicit drugs including cannabis or derivatives for at least three months prior to the study
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/1.73m2 (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

Meir Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBD

Arm Description

At the end of the one month run-in period, all trial subjects will continue on individual Standard of case plus increasing doses of CBD during the first six weeks of the study. Dosage of CBD will start at 25 mg twice a day and will be increased once every 14 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 CBD respectively. Treatment will be given with food. If the 300 mg CBD dose level is deemed safe for two weeks patients will continue receiving 300 mg CBD +for an additional follow-up period of three months

Outcomes

Primary Outcome Measures

Adverse Event reporting 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

change in total steroid dose reporting

Total steroid dose needed to control flares during CBD administration period per patient versus the total steroid dose administered during the one month placebo run-in period

Number of days of flares

Total number of days of flares/month experienced per patient during CBD administration versus the total number of days of flares experienced during the one month placebo run-in period

Secondary Outcome Measures

change in anti histamine use reporting

Percentage of patients who demonstrated a 50% reduction in anti-histamine use during the study

change in quality of life questionnaires

via UAS7, SF36, VAS, Cognitive QoL questionnaire, HDAS at baseline before initiation of CBD administration and at each clinical visit

Full Information

NCT ID

NCT04439955

First Posted

December 16, 2019

Last Updated

June 17, 2020

Sponsor

Stero Biotechs Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04439955

Brief Title

Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

Official Title

A Phase 2a Placebo-controlled, Open-label, Single Center Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (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

Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil). After the run-in period, doses of CBD will be incresed during the first six weeks of the study. At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines, patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional follow-up period of three month. Each patient will serve as his/her own control.

Detailed Description

Each patient will commence the study with a one month run-in period in which he/she will be administered individual patient Standard of Care :anti-histamines and steroids as needed plus placebo (olive oil). At the end of the one month run-in period, all trial subjects will continue on individual Standard of Care plus increasing doses of CBD during the first six weeks of the study. Dosage of CBD will start at 25 mg twice daily and will be increased once every 14 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 CBD respectively. Treatment will be given with food. At the conclusion of the six weeks CBD dose escalation segment of the study, if the 300 mg CBD dose level is deemed safe for two weeks with standard of care doses of anti-histamines, patients will continue receiving 300 mg CBD with Anti-histamines as needed for an additional follow-up period of three months. In the case of flare, the patient will be treated with higher dose of Anti-histamines and Steroides if needed in addition to CBD. Once the flare has been brought under control, then another attempt will be made to discontinue the steroids and continue treating with CBD + Anti-histamines only. Each patient will serve as his/her own control. Laboratory studies will be carried out at the beginning of the study (baseline), and then on a monthly basis until the end of the study. Adverse events will be continuously assessed throughout the study

6. Conditions and Keywords

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

Chronic Spontaneous Urticaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

each patient will commence the study with a one month run-in period in which he/she will be administered individual with placebo (olive oil). At the end of the one month run-in period, all trial subjects will receive CBD

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CBD

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

CBD

Intervention Description

300 mg CBD

Primary Outcome Measure Information:

Title

Adverse Event reporting of up to 300 mg CBD/day

Description

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

6 month

Title

change in total steroid dose reporting

Description

Total steroid dose needed to control flares during CBD administration period per patient versus the total steroid dose administered during the one month placebo run-in period

Time Frame

6 month

Title

Number of days of flares

Description

Total number of days of flares/month experienced per patient during CBD administration versus the total number of days of flares experienced during the one month placebo run-in period

Time Frame

6 month

Secondary Outcome Measure Information:

Title

change in anti histamine use reporting

Description

Percentage of patients who demonstrated a 50% reduction in anti-histamine use during the study

Time Frame

6 month

Title

change in quality of life questionnaires

Description

via UAS7, SF36, VAS, Cognitive QoL questionnaire, HDAS at baseline before initiation of CBD administration and at each clinical visit

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with active CSU for at least 4 months which was treated with anti-histamines as well as at least one course of steroids (ex. Prednisone) Age ≥18 years 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 Other chronic dermatological conditions under active treatment Active consumption of illicit drugs including cannabis or derivatives for at least three months prior to the study 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/1.73m2 (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

Ronit Konfino, Prof.

Phone

97297472718

ronitco@clalit.org.il

Facility Information:

Facility Name

Meir Medical Center

City

Kfar Saba

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronit Konfini, Prof.

ronitco@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

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