Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT06444867
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 158968
Sponsor:
LEO Pharma
Organization:
Study Overview
Official Title:
An Open-label, Phase 1b, Multi-site Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following a Single Dose of LEO 158968 in Subjects With Gout Flares
Status:
COMPLETED
Status Verified Date:
2025-11
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 main objective of the study is to evaluate the effect on pain of a single, subcutaneous (SC) dose of LEO 158968 in participants with gout flares.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-508793-29-00 | CTIS | None | View |