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

• Status: Recruiting
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stero Biotechs Ltd.

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