Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-01 @ 11:19 PM
Study NCT ID:
NCT05286567
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa.
Sponsor:
Aarhus University Hospital
Organization:
Study Overview
Official Title:
An Investigator Initiated, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Proof-Of-Concept Study to Assess the Safety and Efficacy of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Suppurativa
Status:
COMPLETED
Status Verified Date:
2023-01
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:
This is a 16-week treatment, randomized, double-blind, proof-of-concept study designed to assess the safety and efficacy of RGRN-305 compared to placebo for use in future efficacy Phase 2 trials.
Male or female subjects aged 18 years or older with moderate to severe hidradenitis suppurativa will be included in this study.
Objectives are to determine the efficacy and safety of RGRN-305 in patients with moderate to severe hidradenitis supppurativa.
Male or female subjects aged 18 years or older with moderate to severe hidradenitis suppurativa will be included in this study.
Objectives are to determine the efficacy and safety of RGRN-305 in patients with moderate to severe hidradenitis supppurativa.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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 |
|---|---|---|---|---|
| 2021-000881-13 | EUDRACT_NUMBER | None | View |