A Phase III study of efficacy and safety of ligelizumab in the treatment of CSU in adolescents and adults inadequately controlled with H1-antihistamines
- Conditions
- Chronic Spontaneous Urticaria
- Registration Number
- JPRN-jRCT2080224087
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 90
*Diagnosis of chronic spontaneous urticaria for at least 6 months
*Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization
*History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes
*Clearly defined cause of chronic urticaria other than chronic spontaneous urticaria
*Evidence of parasitic infection
*Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results
*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.
Other protocol defined inclusion/exclusion may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Absolute change from baseline in UAS7 at Week 12 [ Time Frame: Week 12 ]<br>The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42.<br>Complete hives response is defined as HSS7 (average daily HSS over the preceding 7 days) = 0.<br>Complete itch response is defined as ISS7 (average daily ISS over the preceding 7 days) = 0.<br>Complete UAS7 response is defined as UAS7=0.
- Secondary Outcome Measures
Name Time Method efficacy<br>Complete absence of hives and itch at Week 12 [ Time Frame: Week 12 ]<br>Assessed as percentage of subjects achieving UAS7 = 0<br>efficacy<br>Improvement of severity of itch [ Time Frame: Week 12]<br>Assessed as absolute change from baseline in ISS7 score at Week 12<br>efficacy<br>No impact on subject's quality of life at Week 12 [ Time Frame: Week 12 ]<br>Assessed as percentage of subjects achieving DLQI = 0-1<br>efficacy<br>Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 [ Time Frame: Weekly to Week 12 ]<br>To assess the cumulative period of time that treated subjects are angioedema occurrence-free<br>safety<br>Occurrence of treatment emergent adverse events and serious adverse events during the study [ Time Frame: 52 weeks ]<br>Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started