A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
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|ClinicalTrials.gov Identifier: NCT03580356|
Recruitment Status : Active, not recruiting
First Posted : July 9, 2018
Last Update Posted : June 3, 2021
The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.
The study population will consist of approximately 1050 male and female subjects aged ≥ 12 years who have been diagnosed with CSU and who remain symptomatic despite the use of H1-antihistamines. Of these, approximately 1000 adults and 50 adolescents are planned for inclusion in the study.
This is a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spontaneous Urticaria||Biological: Ligelizumab Biological: Omalizumab Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1078 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a Phase III multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Patients, investigator staff and personnel performing the study assessments will remain blinded to the identity of the treatment from the time of randomization until final database lock. The study drug must be prepared by an independent unblinded pharmacist (or authorized delegate) and administered by an independent unblinded study drug administrator. Neither the unblinded pharmacist nor the unblinded study drug administrator will be involved in any assessments.|
|Official Title:||A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines|
|Actual Study Start Date :||October 20, 2018|
|Estimated Primary Completion Date :||June 22, 2021|
|Estimated Study Completion Date :||June 21, 2022|
Experimental: Ligelizumab Dose A
Ligelizumab Dose A q4w
Liquid in vial
Experimental: Ligelizumab Dose B
Ligelizumab Dose B q4w
Liquid in vial
Active Comparator: Omalizumab 300 mg
Omalizumab 300 mg q4w
Lyophilized powder for solution in vial
Placebo Comparator: Placebo
Placebo q4w from randomization to week 20. Ligelizumab Dose B from week 24 to week 48.
Liquid in vial
- Absolute change from baseline in UAS7 at Week 12 [ Time Frame: Week 12 ]
The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS).
The HSS has a scale of 0 (none) to 3 (intense/severe). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days.
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days.
The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42.
Complete hives response is defined as HSS7 (average daily HSS over the preceding 7 days) = 0.
Complete itch response is defined as ISS7 (average daily ISS over the preceding 7 days) = 0.
Complete UAS7 response is defined as UAS7=0.
- Complete absence of hives and itch at Week 12 [ Time Frame: Week 12 ]Assessed as percentage of subjects achieving UAS7 = 0
- Improvement of severity of itch [ Time Frame: Week 12 ]Assessed as absolute change from baseline in ISS7 score at Week 12
- No impact on subject's quality of life at Week 12 [ Time Frame: Week 12 ]Assessed as percentage of subjects achieving DLQI = 0-1
- Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 [ Time Frame: Weekly to Week 12 ]To assess the cumulative period of time that treated subjects are angioedema occurrence-free
- Occurrence of treatment emergent adverse events and serious adverse events during the study [ Time Frame: 52 weeks ]Treatment emergent adverse events and serious adverse events are those which occur at any time only after treatment has started
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580356