Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05677451
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2022-12-16
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:
Novartis
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Trial to Evaluate the Efficacy Pharmacokinetics and Safety of Remibrutinib LOU064 for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is
1 to assess the efficacy pharmacokinetics and safety of remibrutinib vs placebo in adolescents from 12 to 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines
2 to collect long-term efficacy safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment
3 to collect safety data in this population for up to three years after the last dose of study treatment
1 to assess the efficacy pharmacokinetics and safety of remibrutinib vs placebo in adolescents from 12 to 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines
2 to collect long-term efficacy safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment
3 to collect safety data in this population for up to three years after the last dose of study treatment
Detailed Description:
This trial consists of 3 different periods
1 the core period which is randomized and double-blind during which 23 participants will receive remibrutinib and 13 will receive placebo for 24 weeks Total duration approximately 32 weeks 10 site visits
2 an optional open-label extension OLE period proposed to all participants who completed 24 weeks of treatment of the core period and all scheduled assessments planned at week 24 visit Depending on their CSU symptoms as assessed by the doctor participants will either receive remibrutinib for 24 weeks or enter an observational treatment-free period for 1 year If the CSU symptoms return during the observational period the participants can switch to the treatment period at any time decided by the doctor At the end of the 24-week treatment period if CSU is controlled participants will enter the 1-year observational period otherwise they can continue with another cycle of 24-week remibrutinib treatment The number of remibrutinib treatment or observational cycles will be limited to 6 times each Total duration from 1 year to approximately 3 years and number of visits from 3 to 15 depending on the CSU symptoms
3 an optional long-term treatment-free follow-up period proposed to all participants who completed at least 4 months treatment in the OLE period No treatment will be given Duration 3 years with 1 site visit and up to 4 phone call follow-up visits
The primary clinical question of interest is what is the effect of remibrutinib treatment versus placebo on the change from baseline in UAS7 ISS7 and HSS7 scores after 12 weeks of treatment
1 the core period which is randomized and double-blind during which 23 participants will receive remibrutinib and 13 will receive placebo for 24 weeks Total duration approximately 32 weeks 10 site visits
2 an optional open-label extension OLE period proposed to all participants who completed 24 weeks of treatment of the core period and all scheduled assessments planned at week 24 visit Depending on their CSU symptoms as assessed by the doctor participants will either receive remibrutinib for 24 weeks or enter an observational treatment-free period for 1 year If the CSU symptoms return during the observational period the participants can switch to the treatment period at any time decided by the doctor At the end of the 24-week treatment period if CSU is controlled participants will enter the 1-year observational period otherwise they can continue with another cycle of 24-week remibrutinib treatment The number of remibrutinib treatment or observational cycles will be limited to 6 times each Total duration from 1 year to approximately 3 years and number of visits from 3 to 15 depending on the CSU symptoms
3 an optional long-term treatment-free follow-up period proposed to all participants who completed at least 4 months treatment in the OLE period No treatment will be given Duration 3 years with 1 site visit and up to 4 phone call follow-up visits
The primary clinical question of interest is what is the effect of remibrutinib treatment versus placebo on the change from baseline in UAS7 ISS7 and HSS7 scores after 12 weeks of treatment
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 |
|---|---|---|---|
| 2022-502159-78-00 | OTHER | EU CT Number | None |
| 2022-502159-78 | EUDRACT_NUMBER | None | None |