Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04210843
Status:
TERMINATED
Last Update Posted:
2024-06-20
First Post:
2019-12-17
Brief Title:
Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Multi-center Double-blinded and Open-label Extension Study to Evaluate the Efficacy and Safety of Ligelizumab as Retreatment Self-administered Therapy and Monotherapy in Chronic Spontaneous Urticaria Patients Who Completed Studies CQGE031C2302 CQGE031C2303 CQGE031C2202 or CQGE031C1301
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to a strategic decision by Novartis to discontinue development of ligelizumab in CSU This decision was not based on any safety concerns
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 extension study was to establish efficacy and safety of ligelizumab This was assessed in adult and adolescent chronic spontaneous urticaria CSU patients who had completed a preceding ligelizumab study and have relapsed following treatment in these preceding studies despite standard of care H1-antihistamine H1-AH treatment
This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies CQGE031C2302 NCT03580369 CQGE031C2303 NCT03580356 CQGE031C2202 NCT03437278 or CQGE031C1301 NCT03907878
This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies CQGE031C2302 NCT03580369 CQGE031C2303 NCT03580356 CQGE031C2202 NCT03437278 or CQGE031C1301 NCT03907878
Detailed Description:
This was a Phase IIIb multi-center double-blinded and open-label extension study to evaluate efficacy and safety of ligelizumab retreatment with H1-AHs background therapy with an option for ligelizumab monotherapy ie discontinuation of background H1-AH in adult and adolescent CSU participants who had completed one of the preceding studies in the setting of retreatment and self-administration
Participants with weekly urticaria activity score UAS7 16 during screening entered the first investigational treatment-free observation period OBS1 with a duration up to 36 weeks
Participants with UAS7 16 during screening or OBS1 were assigned to 1 of the 2 treatment arms and entered the treatment period first half treatment period referred to as TRT1 The first half treatment period TRT1 was 52 weeks from Week 0 to Week 52 Participants remained on the same H1-AH background medication they were taking in the preceding studies TRT1 was divided into
The first 12 weeks in TRT1
i participants transitioning from CQGE031C2302 NCT03580369 and CQGE031C2303 NCT03580356 previously treated with ligelizumab 72 mg liquid in vial subcutaneously sc every 4 weeks Q4W were treated with the same dose regimen in a double-blind manner in this extension study ii all other participants transitioning from CQGE031C2302 NCT03580369 and CQGE031C2303 NCT03580356 were treated with ligelizumab 120 mg liquid in vial sc Q4W in a double-blind manner in this extension study iii participants transitioning from CQGE031C1301 NCT03907878 and CQGE031C2202 NCT03437278 were treated with ligelizumab 120 mg liquid in vial sc Q4W in an open-label manner in this extension study
After the first 12 weeks in TRT1 and up to Week 52 all participants were switched to ligelizumab 120 mg sc pre-filled syringe PFS Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab outside the clinic
The second half of the treatment period TRT2 was 52 weeks from Week 52 to Week 104 Participants with UAS76 and 16 or with UAS7 16 for whom the benefit-risk was deemed as positive by the investigator at Week 52 of TRT1 were transitioned to the TRT2 ligelizumab 120 mg sc Q4W PFS unless a decision to stop treatment was made based on a risk-benefit assessment They were not allowed to discontinue H1- AH background medication
Participants with UAS7 6 at Week 52 of TRT1 entered the second investigational treatment-free observation period OBS2 for up to 52 weeks and remained on the same H1-AH background medication they were taking in the preceding studies Participants with UAS7 6 at Week 52 of TRT1 who entered the second observation period OBS2 and relapsed UAS7 16 were transitioned to the TRT2 and were also offered the opportunity to discontinue their H1-AH background medication ie ligelizumab 120 mg sc q4w PFS monotherapy after 12 weeks in TRT2 Participants who entered the OBS2 and did not relapse UAS716 exited the study at the end of the OBS2 period
Finally participants who were in TRT2 entered the post-treatment follow-up period after treatment discontinuation with duration of 12 weeks for participants who did not complete a continuous 104-week treatment or 52 weeks for participants who completed the full 104-week treatment period without interruption Participants who decided to remain on H1-AH background medication continued to use H1-AH background medication Participants who decided to go off H1- AH background medication continued to remain off
Participants with weekly urticaria activity score UAS7 16 during screening entered the first investigational treatment-free observation period OBS1 with a duration up to 36 weeks
Participants with UAS7 16 during screening or OBS1 were assigned to 1 of the 2 treatment arms and entered the treatment period first half treatment period referred to as TRT1 The first half treatment period TRT1 was 52 weeks from Week 0 to Week 52 Participants remained on the same H1-AH background medication they were taking in the preceding studies TRT1 was divided into
The first 12 weeks in TRT1
i participants transitioning from CQGE031C2302 NCT03580369 and CQGE031C2303 NCT03580356 previously treated with ligelizumab 72 mg liquid in vial subcutaneously sc every 4 weeks Q4W were treated with the same dose regimen in a double-blind manner in this extension study ii all other participants transitioning from CQGE031C2302 NCT03580369 and CQGE031C2303 NCT03580356 were treated with ligelizumab 120 mg liquid in vial sc Q4W in a double-blind manner in this extension study iii participants transitioning from CQGE031C1301 NCT03907878 and CQGE031C2202 NCT03437278 were treated with ligelizumab 120 mg liquid in vial sc Q4W in an open-label manner in this extension study
After the first 12 weeks in TRT1 and up to Week 52 all participants were switched to ligelizumab 120 mg sc pre-filled syringe PFS Q4W in an open-label manner and they were offered an opportunity to self-administer ligelizumab outside the clinic
The second half of the treatment period TRT2 was 52 weeks from Week 52 to Week 104 Participants with UAS76 and 16 or with UAS7 16 for whom the benefit-risk was deemed as positive by the investigator at Week 52 of TRT1 were transitioned to the TRT2 ligelizumab 120 mg sc Q4W PFS unless a decision to stop treatment was made based on a risk-benefit assessment They were not allowed to discontinue H1- AH background medication
Participants with UAS7 6 at Week 52 of TRT1 entered the second investigational treatment-free observation period OBS2 for up to 52 weeks and remained on the same H1-AH background medication they were taking in the preceding studies Participants with UAS7 6 at Week 52 of TRT1 who entered the second observation period OBS2 and relapsed UAS7 16 were transitioned to the TRT2 and were also offered the opportunity to discontinue their H1-AH background medication ie ligelizumab 120 mg sc q4w PFS monotherapy after 12 weeks in TRT2 Participants who entered the OBS2 and did not relapse UAS716 exited the study at the end of the OBS2 period
Finally participants who were in TRT2 entered the post-treatment follow-up period after treatment discontinuation with duration of 12 weeks for participants who did not complete a continuous 104-week treatment or 52 weeks for participants who completed the full 104-week treatment period without interruption Participants who decided to remain on H1-AH background medication continued to use H1-AH background medication Participants who decided to go off H1- AH background medication continued to remain off
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 |
|---|---|---|---|
| 2019-001792-37 | EUDRACT_NUMBER | None | None |