Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT02915835
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2016-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Riociguat in Scleroderma Associated Digital Ulcers
Sponsor:
Dinesh Khanna, MD, MS
Organization:
Study Overview
Official Title:
A Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital Ulcers
Status:
COMPLETED
Status Verified Date:
2019-09
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:
RESCUE
Brief Summary:
The primary objective of this study is to provide preliminary data on the efficacy (digital ulcer net burden) and safety of riociguat administered 3 times daily (TID) in comparison to placebo in patients with scleroderma-associated digital ulcers
Detailed Description:
This clinical trial is a US, multicenter, double-blind, randomized placebo-controlled, parallel- group study with a total of 20 participants planned to be randomized (approximately 10 participants to the riociguat group and 10 to the placebo group). In addition, a standardized wound care protocol will be followed by the investigators and digital photography will be taken of the cardinal ulcer.
The study will allow standard of care medications for the management of DU as background therapy. These may include calcium channel blockers, low dose aspirin, angiotensin enzyme inhibitors, etc. and will be determined by the participant's local physician.
The study design consists of three phases:
* Screening phase: up to 2 weeks
* Double-blind Treatment phase: 16 weeks of double-blind treatment, consisting of:
* Dose titration period of up to 8 weeks, and
* Stable dosing period of up to 8 weeks
* Open-label Extension phase for participants with active DU at the end of the double- blind treatment phase or development of an active DU within a month of completing double-blind phase, consisting of:
* Dose titration phase of up to 8 weeks
* Stable dosing period for 8 weeks
The study will allow standard of care medications for the management of DU as background therapy. These may include calcium channel blockers, low dose aspirin, angiotensin enzyme inhibitors, etc. and will be determined by the participant's local physician.
The study design consists of three phases:
* Screening phase: up to 2 weeks
* Double-blind Treatment phase: 16 weeks of double-blind treatment, consisting of:
* Dose titration period of up to 8 weeks, and
* Stable dosing period of up to 8 weeks
* Open-label Extension phase for participants with active DU at the end of the double- blind treatment phase or development of an active DU within a month of completing double-blind phase, consisting of:
* Dose titration phase of up to 8 weeks
* Stable dosing period for 8 weeks
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: