chronic idiopathic urticaria
Conditions
Interventions
Bilastine Group:Bilastine 20 mg + Levocetirizine-like dummy placebo
Levocetirizine Group:Levocetirizine 5 mg + Bilastine-like dummy placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects will be eligible for study participation if they meet the following criteria: 1. Subjects of either sex between 18 and 65 years of age (inclusive) on the date of consent. 2. Subjects having given their written informed consent to participate in the study after receiving information about the design, aims and potential risks that could result from the study and being informed that they could refuse to participate or withdraw from the study at any time. 3. Subjects with documented clinical history of CIU, for at least 6 weeks prior to the study screening visit, characterized by erythematous skin wheals accompanied by itching, occurring regularly, at least 2 times per week. 4. Subjects with active CIU in the week (7days) before screening. Subjects should have for at least 3 days (consecutive or not) a moderate score (= 2) for at least 2 of the following symptoms. This will be assessed retrospectively by subjects and Investigator. • Itching intensity 0 = Absent 1 = Mild (not annoying) 2 = Moderate (little disruption of activity) 3 = Severe (intense with disruption of activity) • Wheals number 0 = Absent 1 = Some (= 10) 2 = Numerous (> 10) 3 = Extensive areas of the body covered • Maximum size (diameter) of the wheals 0 = Absent 1 = = 1.5 cm 2 = > 1.5 cm < 2.5 cm 3 = = 2.5 cm 5. Subjects willing to attend the required visits scheduled in the protocol, and fill in the diaries provided.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria should not be enrolled in this study: 1. Subjects who suffer other kind of dermatological pathology that can interfere in the evaluation of the CIU: isolated hereditary angioedema, dermographism, physical urticaria, urticaria due to a medicine or food allergy, infectious urticaria, contact urticaria, urticaria caused by vasculitis and/or collagenosis, paraneoplastic urticaria, parasitary urticaria, urticaria related with thyroid pathology, eczema, or atopic dermatitis. 2. Subjects who have a history of autoimmune disorders, Hodgkin’s disease, lymphoma, leukemia, or generalized cancer. 3. Subjects who had taken any of the below medications before the study enrolment or currently taking any of the below medications, without the required washout period as mentioned below: Note: These washout periods should refer to the estimated randomization date (Day 0). The randomization date can be adjusted to ensure subject passed the washout period. o Topical glucocorticoid (2 weeks); systemic glucocorticoid (4 weeks), slow-release glucocorticoid (3 months). o Antihistamines: loratadine and desloratadine (3 days), ketotifen (1 week) other systemic antihistamines (1 week) o Anti-leukotrienes (2 weeks) o Macrolide antibiotics (3 days) or systemic imidazole antifungal agents (5 days) o Anticholinergics (3 days) o Medications with antihistamine or sedating properties or medications not listed, the period of time without taking these specific drugs can be discussed by Investigator and medical advisor on a case-by-case basis. o Biologicals (such as omalizumab) (6 months) o Immunosuppressants (such as ciclosporin/tripterygium/Methotrexate, etc) (1 month) o Immunomodulator (1 month); o Traditional Chinese medicine used for urticaria (such as Glycyrrhizin) (1 month). 4. Subjects who need to receive prohibited concomitant medications as specified in Section 8.7. 5. Subjects with hypersensitivity to levocetirizine, bilastine, or benzimidazole or its ingredients. 6. Subjects with uncontrolled, clinically significant disorders of the liver, kidney, cardiovascular system, respiratory system, endocrine system, hematological diseases, urological system, metabolic diseases or central nervous system. 7. Subjects with clinically significant abnormal ECG deemed inappropriate for study entry by the Investigator. 8. Subjects with long QT syndrome (Defined as QTc > 450 ms for male or QTc > 470 ms for female). 9. Subjects with a recent history (within previous 6 months) of drug addiction or alcohol abuse. 10. Female subjects who are pregnant or breast-feeding, or have the possibility of pregnancy who cannot use or have no plan to use medically acceptable contraceptive method. 11. Subjects with any other condition which the Investigator considers unsuitable for inclusion in the study. 12. Subjects are study site personnel directly affiliated with this study; and/or their immediate families. Immediate family is defined as spouse, parent, child, or sibling, whether biological or legally adopted. 13. Significant medical condition, in the opinion of the Investigator, rendering the subject immunocompromised or not suitable for a clinical trial. 14. Drinking or ingesting grapefruit, pomegranate, grapefruit juice, or grapefruit containing products within 1 week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline (Day 0) in the morning (ante meridiem; AM) and night (post meridiem; PM) (mean of both) total symptom score (TSS3) over the 28 days of the treatment period according to the subject’s assessment in the subject diary (Reflective symptoms, which is the evaluation of symptoms over the previous 12 hours); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in each of the AM/PM symptoms score (itching intensity symptom, wheals number symptom and maximum size [diameter] of the wheals symptom) over the 28 days of treatment period according to the subject’s assessment in the subject diary (Reflective symptoms);Change from baseline in the AM/PM (mean of both) Urticaria Composite Score (UCS2) over the 28 days of treatment period according to the subject’s assessment in the subject diary (Reflective symptoms);Change in the TSS3 according to the subject’s assessment on Day 28 visit versus Day 0 visit and on Day 14 visit versus Day 0 visit (Instantaneous symptoms);Change in each of the symptoms score according to the subject’s assessment on Day 28 visit versus Day 0 visit and on Day 14 visit versus Day 0 visit (Instantaneous symptoms);Change in the TSS3 according to the Investigator’s assessment on Day 28 visit versus Day 0 visit and on Day 14 visit versus Day 0 visit (Instantaneous symptoms);Change in each symptoms score according to the Investigator’s assessment on Day 28 visit versus Day 0 visit and on Day 14 visit versus Day 0 visit (Instantaneous symptoms); Change in the UCS2 according to the subject’s assessment on Day 28 visit versus Day 0 visit and on Day 14 visit versus Day 0 visit (Instantaneous symptoms);Change in the UCS2 according to the Investigator’s assessment on Day 28 visit versus Day 0 visit and on Day 14 visit versus Day 0 visit (Instantaneous symptoms);Area under curve of total symptoms’ score (TSS3) over the treatment period, according to the subject’s assessment in the subject diary;Area under curve of UCS2 over the treatment period, according to the subject’s assessment in the subject diary;Investigator’s overall GCI assessment; Changes from baseline in the QoL index assessed by the DLQI (Day 0 vs Day 28); Overall assessment of discomfort caused by CIU using | — |
Countries
China
Contacts
Public ContactJianzhong Zhang
Peking University People's Hospital
Outcome results
None listed