Status:
COMPLETED
Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients
Lead Sponsor:
Stero Biotechs Ltd.
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04439955
Start Date
February 1 2020
End Date
July 30 2021
Last Update
April 18 2024
Active Locations (1)
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1
Meir Medical Center
Kfar Saba, Israel