Gusacitinib for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
It depends on the medication. If you're on immunosuppressants, you'll need to stop them 2 weeks before starting the study drug and remain off them during the trial. If you're on glucocorticoids or hydroxychloroquine, you can continue them if the doses are stable. Other medications like those for diabetes, hypertension, or statins can also be continued if stable. The protocol does not specify for other medications, so check with the study team.
What safety data is available for Gusacitinib in treating lupus?
The provided research does not contain specific safety data for Gusacitinib (also known as ASN-002, ASN002, EN-3351, EN3351, WHO 10976) in the treatment of lupus. The studies mentioned focus on other treatments such as GSK2586184, baricitinib, deucravacitinib, and voclosporin, which are different drugs. Therefore, no relevant safety data for Gusacitinib is available in the provided research.12345
Is the drug Gusacitinib a promising treatment for Lupus?
What data supports the idea that Gusacitinib for Lupus is an effective treatment?
The available research does not provide any specific data on Gusacitinib for treating Lupus. Instead, it discusses other drugs like Baricitinib, Pacritinib, Deucravacitinib, and GSK2586184. These studies focus on their effects on Lupus, but none mention Gusacitinib. Therefore, there is no data here to support the effectiveness of Gusacitinib for Lupus.135710
Who Is on the Research Team?
Sarfaraz A Hasni, M.D.
Principal Investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with lupus, a condition where the immune system attacks healthy tissue. Participants will undergo various tests including physical exams, blood and urine analysis, heart function tests, chest X-rays, and blood flow measurements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive either Gusacitinib or placebo once a day for 12 weeks
Treatment Part 2
All participants who took the study drug or placebo in part 1 will take Gusacitinib once a day for 12 weeks
Off-drug Period
Participants who took the study drug will stop taking it for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gusacitinib
Gusacitinib is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Lead Sponsor