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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

Must not have

Subjects with active renal or central nervous system involvement due to SLE or a BILAG A in any organ system

Subject has a history of congestive heart failure of class III or IV as per the New York Heart Association (NYHA) classification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lupus affects my kidneys, brain, or has severely impacted another organ.

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I have severe heart failure (NYHA class III or IV).

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I have had two or more untreated blood clots in my veins.

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I have a history of diverticulitis.

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I have used antibiotics through an IV in the last 2 weeks.

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I have a history of liver disease or high liver function tests.

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My liver function is moderately or severely impaired.

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My cholesterol or triglyceride levels are high based on a recent test.

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I am not on strong medications that affect liver enzymes CYP3A4 or CYP2C19.

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I am not on medications that strongly affect certain liver enzymes or drug transporters.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I haven't had major surgery in the last 8 weeks and don't plan any during the study.

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I tested positive for hepatitis B, C, HIV, or BK virus.

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I have active tuberculosis or a positive TB test.

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I have not received a live vaccine recently and won't during the study.

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My blood pressure is not well-managed with my current medications.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.