What side effects are associated with this type of intervention?

Common treatments for intermediate uveitis include corticosteroids, immunosuppressive agents, and biologics such as anti-TNF-α agents and tocilizumab. Corticosteroids can cause side effects like increased intraocular pressure, cataracts, and systemic effects with long-term use. Immunosuppressive agents may lead to increased infection risk and liver toxicity. Anti-TNF-α agents and tocilizumab can cause injection site reactions, increased risk of infections, and potential liver enzyme abnormalities. Janus Kinase Inhibitors like Brepocitinib, while still under study, may have side effects including infections, gastrointestinal disturbances, and potential blood count abnormalities.

What prior FDA approvals exist?

FDA-approved treatments for intermediate uveitis include corticosteroids, immunosuppressive agents like methotrexate, and biologics such as adalimumab. While specific JAK inhibitors like brepocitinib are being studied, they are not yet approved for this indication. However, JAK inhibitors have shown promise in treating other inflammatory conditions, suggesting potential efficacy in uveitis.

What other types of research exist?

Promising novel alternatives to Brepocitinib for Intermediate Uveitis patients include Tofacitinib, which is another JAK inhibitor, and other newly approved agents like Tralokinumab, Abrocitinib, and Upadacitinib. These agents have shown efficacy in treating various inflammatory conditions and may offer potential benefits for uveitis patients.

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Janus Kinase (JAK) Inhibitor

Brepocitinib for Uveitis (NEPTUNE Trial)

Phase 2

Waitlist Available

Research Sponsored by Priovant Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening up to 28 days after the last dose of study drug at 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a pill called brepocitinib in people with a type of eye inflammation that isn't caused by an infection. The pill works by calming the immune system to reduce swelling and irritation in the eye.

Who is the study for?

Adults aged 18-74 with active non-infectious uveitis (intermediate, posterior, or panuveitis) can join. They must have certain levels of eye inflammation and may be on one non-corticosteroid treatment. Weight over 40 kg and BMI under 40 are required. Those with isolated anterior uveitis, recent cancers except some skin or localized cancers, high thrombosis risk, active infections, or herpes zoster risk cannot participate.

What is being tested?

The trial is testing the safety and effectiveness of an oral medication called Brepocitinib for adults with specific types of eye inflammation known as intermediate, posterior, or panuveitis that isn't caused by an infection.

What are the potential side effects?

Potential side effects of Brepocitinib could include risks related to immune system suppression such as increased likelihood of infections. Specific side effects will be monitored throughout the study but are not detailed in the provided information.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening up to 28 days after the last dose of study drug at 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening up to 28 days after the last dose of study drug at 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to 28 days after the last dose of study drug at 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Brepocitinib Dose Level 2 PO QDExperimental Treatment1 Intervention

Group II: Brepocitinib Dose Level 1 PO QDExperimental Treatment1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Intermediate Uveitis include corticosteroids, immunosuppressive agents, and Janus Kinase (JAK) inhibitors like Brepocitinib. Corticosteroids work by reducing inflammation through the suppression of multiple inflammatory pathways, which helps to control the immune response and decrease ocular inflammation. Immunosuppressive agents, such as methotrexate or cyclosporine, inhibit the activity of immune cells that contribute to inflammation, thereby reducing the immune system's attack on ocular tissues. JAK inhibitors, like Brepocitinib, block the activity of Janus kinases, which are enzymes involved in the signaling pathways that lead to inflammation. By inhibiting these pathways, JAK inhibitors can effectively reduce inflammation and immune responses. These treatments are crucial for Intermediate Uveitis patients as they help to control inflammation, prevent vision loss, and improve overall ocular health.