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JAK Inhibitor
Gusacitinib for Lupus
Phase 1
Waitlist Available
Led By Sarfaraz A Hasni, M.D.
Research Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has no to mild disease activity defined as a SLEDAI 2K score between 0-6
Stable doses of immunosuppressant for the 12 weeks prior to the screening visit. The subject will be taken off these immunosuppressant medications 2 weeks prior to administration of study medication and will be kept off these medications for the duration of the study. Any subject experiencing worsening of SLE disease activity will be treated by a single dose of intra-muscular corticosteroid. A second flare during each period requiring treatment would lead to withdrawal of the subject. The subjects in comparator group will continue on standard of care treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Study Summary
"This trial is testing a new drug called Gusacitinib in people with lupus, a disease where the immune system attacks healthy tissue. The study will involve participants aged 18 and older and will
Who is the study for?
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.Check my eligibility
What is being tested?
The drug Gusacitinib is being tested in people with lupus. The study has three parts: initially comparing Gusacitinib to a placebo for 12 weeks; then all participants take Gusacitinib for another 12 weeks; finally, those on the drug stop it for four weeks to observe effects.See study design
What are the potential side effects?
Potential side effects of Gusacitinib are not detailed here but may include typical drug reactions such as nausea, headaches, possible allergic reactions or specific impacts related to its action on the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lupus activity is low, with a SLEDAI score of 0-6.
Select...
I've been on a steady dose of immunosuppressants for the last 12 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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) v5.0) and frequency as compared to placebo at week 12
Secondary outcome measures
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.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: ControlActive Control1 Intervention
Subjects will remain on their usual SLE medications
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive a placebo that looks similar to the interventional drug.
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Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Lead Sponsor
485 Previous Clinical Trials
1,086,849 Total Patients Enrolled
2 Trials studying Lupus
270 Patients Enrolled for Lupus
Sarfaraz A Hasni, M.D.Principal InvestigatorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
8 Previous Clinical Trials
10,125 Total Patients Enrolled
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