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

June 17, 2020 updated by: Stero Biotechs Ltd.

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

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.

Study Overview

Status

Unknown

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

20

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

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:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBD
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
300 mg CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event reporting of up to 300 mg CBD/day
Time Frame: 6 month
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
6 month
change in total steroid dose reporting
Time Frame: 6 month
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
6 month
Number of days of flares
Time Frame: 6 month
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
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in anti histamine use reporting
Time Frame: 6 month
Percentage of patients who demonstrated a 50% reduction in anti-histamine use during the study
6 month
change in quality of life questionnaires
Time Frame: 6 month
via UAS7, SF36, VAS, Cognitive QoL questionnaire, HDAS at baseline before initiation of CBD administration and at each clinical visit
6 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)

February 1, 2020

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 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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