Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03580369
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2018-06-26
Brief Title:
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Multi-center Randomized Double-blind Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab QGE031 in the Treatment of Chronic Spontaneous Urticaria CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo
The study population consisted of 1072 male and female subjects aged 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines
This was a multi-center randomized double-blind active- and placebo-controlled parallel-group study There was a screening period of up to 28 days a 52 week double-blind treatment period and a 12 week post-treatment follow-up period
The study population consisted of 1072 male and female subjects aged 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines
This was a multi-center randomized double-blind active- and placebo-controlled parallel-group study There was a screening period of up to 28 days a 52 week double-blind treatment period and a 12 week post-treatment follow-up period
Detailed Description:
This was a Phase III multi-center randomized double-blind active and placebo-controlled parallel-group study The study consisted of 3 distinct periods
Screening period Day -28 to Day 1 Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility
Double-blind treatment period 52 weeks The subjects were seen in the clinic every 4 weeks
Post-treatment follow-up period 12 weeks This period consists of 3 visits every 4 weeks with the final visit occurring 16 weeks after the last dose at Week 48
Screening period Day -28 to Day 1 Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility
Double-blind treatment period 52 weeks The subjects were seen in the clinic every 4 weeks
Post-treatment follow-up period 12 weeks This period consists of 3 visits every 4 weeks with the final visit occurring 16 weeks after the last dose at Week 48
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-000839-28 | EUDRACT_NUMBER | None | None |