The purpose of the study is to evaluate the efficacy and safety of ligelizumab in treating adult andadolescent subjects with chronic spontaneous urticaria
- Registration Number
- CTRI/2018/12/016719
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Signed informed consent must be obtained prior to participation in the study
Male and female subjects >= 12 years of age at the time of screening
CSU diagnosis for>=6 months
•The presence of itch and hives for >= 6 consecutive weeks at any time prior to Visit 1(Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
•UAS7 score (range 0-42) >= 16 and HSS7 (range 0-21) >= 8 during the 7 days prior to randomization (Visit 110, Day 1)
•Subjects must be on H1-antihistamine at only approved doses for treatment of CSU starting at Visit 1(Day -28 to Day -14)
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e.to murine, chimeric or human antibodies).
Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1.If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
Prior exposure to ligelizumab or omalizumab.
Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute change from baseline in UAS7 at week 12Timepoint: Absolute change from baseline in UAS7 at week 12
- Secondary Outcome Measures
Name Time Method â?¢Complete absence of hives and itch <br/ ><br>â?¢Improvement of severity of itch <br/ ><br>â?¢No impact on subjects quality of life at Week <br/ ><br> <br/ ><br>Timepoint: week 12