Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04457336
Status:
TERMINATED
Last Update Posted:
2024-06-10
First Post:
2020-06-25
Brief Title:
A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH
Sponsor:
Spruce Biosciences
Organization:
Spruce Biosciences
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 Tildacerfont in Adult Subjects With Classic Congenital Adrenal Hyperplasia
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study SPR001-203 did not meet its primary and secondary endpoints therefore Spruce Biosciences has decided to terminate the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline on their current GC regimen Optional open label treatment extension period up to 240 weeks with 200mg Tildacerfont QD
Detailed Description:
This is a study that will test the efficacy and safety of Tildacerfont The first 12-weeks will be a double-blind placebo controlled dose ranging study The following 58-weeks will assess the long term safety of Tildacerfont Optional open label treatment extension period up to 240 weeks with 200mg Tildacerfont QD
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 |
|---|---|---|---|
| CAHmelia 203 | OTHER | Spruce Biosciences | None |