Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238531
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-02-01
Brief Title:
A Clinical Trial to Evaluate Safety of Gusacitinib in Patients With Systemic Lupus Erythematosus SLE or Lupus
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase Ib Study to Evaluate the Safety Tolerability And Pharmacokinetics of Gusacitinib in Subjects With Systemic Lupus Erythematosus SLE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-13
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:
Background
Systemic lupus erythematosus SLE also called lupus is a disease that causes the body s immune system to attack healthy tissue Lupus causes swelling and inflammation in the skin skin joints kidneys brain blood vessels and other organs There is no cure for lupus Current treatments do not help everyone and may have adverse effects Better treatments are needed
Objective
To test a study drug Gusacitinib in people with lupus
Eligibility
People aged 18 years and older with lupus
Design
Participants will be screened They will have a physical exam with blood and urine tests and a test of their heart function They will have a chest X-ray They will have tests that use blood pressure cuffs to measure blood flow and pressure throughout the body
Participants will have 9 clinic visits and 6 phone visits over about 7 months
The study has 3 parts
Part 1 Gusacitinib is a tablet taken by mouth Participants will be divided into 3 groups One group will receive the study drug and a second group will get a placebo The placebo looks like the study drug but does not contain any medicine Both of these groups will take their tablets once a day for 12 weeks The third group will continue to take their usual medications for lupus throughout the study
Part 2 All participants who took the study drug or placebo in part 1 will take the study drug once a day for 12 weeks
Part 3 All participants who took the study drug will stop taking it for 4 weeks
Systemic lupus erythematosus SLE also called lupus is a disease that causes the body s immune system to attack healthy tissue Lupus causes swelling and inflammation in the skin skin joints kidneys brain blood vessels and other organs There is no cure for lupus Current treatments do not help everyone and may have adverse effects Better treatments are needed
Objective
To test a study drug Gusacitinib in people with lupus
Eligibility
People aged 18 years and older with lupus
Design
Participants will be screened They will have a physical exam with blood and urine tests and a test of their heart function They will have a chest X-ray They will have tests that use blood pressure cuffs to measure blood flow and pressure throughout the body
Participants will have 9 clinic visits and 6 phone visits over about 7 months
The study has 3 parts
Part 1 Gusacitinib is a tablet taken by mouth Participants will be divided into 3 groups One group will receive the study drug and a second group will get a placebo The placebo looks like the study drug but does not contain any medicine Both of these groups will take their tablets once a day for 12 weeks The third group will continue to take their usual medications for lupus throughout the study
Part 2 All participants who took the study drug or placebo in part 1 will take the study drug once a day for 12 weeks
Part 3 All participants who took the study drug will stop taking it for 4 weeks
Detailed Description:
STUDY DESCRIPTION
This is a phase Ib study of Gusacitinib a dual inhibitor of JAK and SYK kinases that can simultaneously target multiple signaling pathways responsible for the SLE disease pathogenesis This study will compare the safety of Gusacitinib 80 mg with placebo initially in a double-blind period and then 80 mg daily in an open label period followed by an off-drug period
In addition we will have a comparator group of SLE subjects receiving standard of care treatment We hypothesize that Gusacitinib will be safe and well tolerated in subjects with SLE
OBJECTIVES
Primary Objective The primary Objective of the study is to determine safety and tolerability of Gusacitinib 80 mg in subjects with SLE
Secondary Objectives Pharmacokinetics of Gusacitinib in SLE Effects of Gusacitinib on plasma lipid profile vascular stiffness and endothelial dysfunction Efficacy of Gusacitinib in controlling SLE disease activity Exploratory objectives to understand the effects of dual JAK and SYK inhibition on Interferon Gene Signature Serum Cytokines NET formation and Immune cells phenotype
ENDPOINTS
Primary Endpoint Adverse Events severity as defined by AEs equal or greater than grade 3 as per the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE v50 and frequency as compared to placebo at week 12
Secondary Endpoints Change in the proportion of patients achieving SLE Responder Index-4 SRI 4 response at week 24 compared to baseline Another efficacy analysis will be done by comparing subjects treated with Gusacitinib vs placebo at week 12 SRI-4 response is defined as
Reduction of 4 points from baseline in SLEDAI-2K score
No new BILAG A or no more than 1 new BILAG B disease activity scores
No worsening defined as an increase of 03 points 10 mm from baseline in the Physician s Global Assessment of Disease Activity
Change in SLEDAI-2K total score at week 24
This is a phase Ib study of Gusacitinib a dual inhibitor of JAK and SYK kinases that can simultaneously target multiple signaling pathways responsible for the SLE disease pathogenesis This study will compare the safety of Gusacitinib 80 mg with placebo initially in a double-blind period and then 80 mg daily in an open label period followed by an off-drug period
In addition we will have a comparator group of SLE subjects receiving standard of care treatment We hypothesize that Gusacitinib will be safe and well tolerated in subjects with SLE
OBJECTIVES
Primary Objective The primary Objective of the study is to determine safety and tolerability of Gusacitinib 80 mg in subjects with SLE
Secondary Objectives Pharmacokinetics of Gusacitinib in SLE Effects of Gusacitinib on plasma lipid profile vascular stiffness and endothelial dysfunction Efficacy of Gusacitinib in controlling SLE disease activity Exploratory objectives to understand the effects of dual JAK and SYK inhibition on Interferon Gene Signature Serum Cytokines NET formation and Immune cells phenotype
ENDPOINTS
Primary Endpoint Adverse Events severity as defined by AEs equal or greater than grade 3 as per the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE v50 and frequency as compared to placebo at week 12
Secondary Endpoints Change in the proportion of patients achieving SLE Responder Index-4 SRI 4 response at week 24 compared to baseline Another efficacy analysis will be done by comparing subjects treated with Gusacitinib vs placebo at week 12 SRI-4 response is defined as
Reduction of 4 points from baseline in SLEDAI-2K score
No new BILAG A or no more than 1 new BILAG B disease activity scores
No worsening defined as an increase of 03 points 10 mm from baseline in the Physician s Global Assessment of Disease Activity
Change in SLEDAI-2K total score at week 24
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 |
|---|---|---|---|
| 001700-AR | None | None | None |