Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT05677451
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2022-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Sponsor:
Novartis Pharmaceuticals
Organization:
Key Dates - Follows AllAPIJSON File Order
Start Date:
2023-07-11
Start Date Type:
ACTUAL
Primary Completion Date:
2026-04-02
Primary Completion Date Type:
ESTIMATED
Completion Date:
2032-03-30
Completion Date Type:
ESTIMATED
First Submit Date:
2022-12-16
First Submit QC Date:
None
Study First Post Date:
2023-01-10
Study First Post Date Type:
ACTUAL
Results First Submit Date:
None
Results First Submit QC Date:
None
Results First Post Date:
None
Results First Post Date Type:
None
Results First Post QC Date:
None
Results First Post QC Date Type:
None
Disp First Submit Date:
None
Disp First Submit QC Date:
None
Disp First Post Date:
None
Disp First Post Date Type:
None
Last Update Submit Date:
2025-06-27
Last Update Post Date:
2025-06-29
Last Update Post Date Type:
ACTUAL