Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440525
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
A Study of RSLV-132 in Females with Primary Sjögren39s Syndrome
Sponsor:
Resolve Therapeutics
Organization:
Resolve Therapeutics
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants with Primary Sjögrens Syndrome pSS with Moderate to Severe Symptom Burden
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The goal of this clinical study is to learn if RSLV-132 improves the symptoms of pSS in adults It will also learn about the safety of RSLV-132 The main questions it aims to answer are
Does RSLV-132 improve the cardinal symptoms of Sjogrens including fatigue dryness and pain
Does RSLV-132 improve the tirednessfatigue caused by Sjogrens
What are the blood levels of RSLV-132 over time
What is the immune antibody response in the body to RSLV-132
What is the safety profile of RSLV-132
Researchers will compare RSLV-132 to a placebo a look-alike substance that contains no drug to see if RSLV-132 improves the symptoms of pSS
Participants will
Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks then every 2 weeks until the end of treatment and then for a final time 4 weeks later Day 211 for check-ups tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device
Does RSLV-132 improve the cardinal symptoms of Sjogrens including fatigue dryness and pain
Does RSLV-132 improve the tirednessfatigue caused by Sjogrens
What are the blood levels of RSLV-132 over time
What is the immune antibody response in the body to RSLV-132
What is the safety profile of RSLV-132
Researchers will compare RSLV-132 to a placebo a look-alike substance that contains no drug to see if RSLV-132 improves the symptoms of pSS
Participants will
Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks then every 2 weeks until the end of treatment and then for a final time 4 weeks later Day 211 for check-ups tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device
Detailed Description:
None
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