Last updated: April 16, 2024
Sponsor: Stero Biotechs Ltd.
Overall Status: Completed
Phase
2
Condition
Urticaria
Hives (Urticaria)
Treatment
CBD
Clinical Study ID
NCT04439955
ST-SCU-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with active CSU for at least 4 months which was treated with anti-histaminesas 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 afollicle stimulating hormone test), or who are surgically sterilized may be enrolled.Similarly, women of childbearing potential who had a negative pregnancy test atscreening, who are willing to use two medically acceptable methods of contraceptionfor the duration of the study as well as for at least three months after cessation ofCBD treatment and who are willing to undergo pregnancy testing according to the studyprotocol may be enrolled.
- Female subjects who are not breast-feeding and who have no intention to breast-feedduring the term of the trial and for at least three months after cessation of CBDtreatment may be enrolled.
- Subject able to provide written informed consent
Exclusion
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 leastthree months prior to the study
- Patients with significant cardiac, respiratory or active malignance disease (exceptBasel 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 15-29mL/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 orbreastfeeding
Study Design
Total Participants: 15
Treatment Group(s): 1
Primary Treatment: CBD
Phase: 2
Study Start date:
February 01, 2020
Estimated Completion Date:
July 30, 2021
Study Description
Connect with a study center
Meir Medical Center
Kfar Saba,
IsraelSite Not Available
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