We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04439955
Recruitment Status : Unknown
Verified June 2020 by Stero Biotechs Ltd..
Recruitment status was:  Recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
Stero Biotechs Ltd.

Tracking Information
First Submitted Date  ICMJE December 16, 2019
First Posted Date  ICMJE June 19, 2020
Last Update Posted Date June 19, 2020
Actual Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Chronic Spontaneous Urticaria
Intervention  ICMJE Drug: CBD
300 mg CBD
Study Arms  ICMJE 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
Intervention: Drug: CBD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 17, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04439955
Other Study ID Numbers  ICMJE ST-SCU-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Stero Biotechs Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stero Biotechs Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stero Biotechs Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP