Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04628481
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2020-11-09
Brief Title:
A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
Sponsor:
Dompé Farmaceutici SpA
Organization:
Dompé Farmaceutici SpA
Study Overview
Official Title:
Phase 3 Multicenter Randomized Double-blind Placebo-controlled Study to Assess Efficacy - Safety of 400 mg Twice a Day Oral Ladarixin in Pts With Recent Onset Type 1 Diabetes and Low Residual β-cell Function at Baseline GLADIATOR STUDY
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
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 objective of this clinical trial is to assess whether ladarixin treatment is effective in preserving beta-cell function and delaying the progression of type 1 diabetes T1D in adolescent and adult patients The safety of ladarixin in the specific clinical setting will be also evaluated
Detailed Description:
This is a phase 3 multicenter double-blind placebo-controlled study It has been designed to further evaluate whether ladarixin is effective in preserving beta-cell function and slowing-down the progression of T1D in patients with a more severe disease presentation
The study is planned to be performed at about 40 study centers in EU US and in other countries if appropriated At each study center the Principal Investigator PI will be responsible for ensuring that the investigation is conducted according to the signed Investigator agreement the protocol GCP guidelines and local regulations
The study is planned to involve -327 patients with new-onset T1D to include about 200 adolescents 14-17 years Patients will be randomly 21 assigned to receive either ladarixin treatment 400 mg bid for 13 cycles of 14 days on14 days off - treatment group or matched placebo control group The two groups will be balanced within centers
The study is planned to be performed at about 40 study centers in EU US and in other countries if appropriated At each study center the Principal Investigator PI will be responsible for ensuring that the investigation is conducted according to the signed Investigator agreement the protocol GCP guidelines and local regulations
The study is planned to involve -327 patients with new-onset T1D to include about 200 adolescents 14-17 years Patients will be randomly 21 assigned to receive either ladarixin treatment 400 mg bid for 13 cycles of 14 days on14 days off - treatment group or matched placebo control group The two groups will be balanced within centers
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 |
|---|---|---|---|
| 2020-001926-71 | EUDRACT_NUMBER | None | None |