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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 below

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My lupus activity is low, with a SLEDAI score of 0-6.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Lead Sponsor

483 Previous Clinical Trials

1,086,880 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being accepted for enrollment in this clinical trial?

"As per clinicaltrials.gov, this investigation is not presently open for participant enrollment. Originally shared on 2/7/2024 and last modified on 2/1/2024, the trial's recruitment phase has ceased. Nonetheless, there are currently 146 alternative studies actively seeking participants."

Answered by AI

What are the safety implications of Gusacitinib for individuals receiving treatment?

"Our team at Power rated the safety of Gusacitinib a 1 on our scale, as this Phase 1 trial has minimal data supporting both its safety and effectiveness."

Answered by AI

Is the clinical trial open to individuals above the age of 85?

"To be considered for this research study, individuals aged between 18 and 99 are eligible. It is noteworthy that there are separate trials available specifically designed for those under 18 years old (26 trials) and over 65 years old (124 trials)."

Answered by AI