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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

NEPTUNE Trial Summary

This trial will test a new drug, brepocitinib, for treating uveitis, a painful inflammation of 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.Check my eligibility

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.See study design

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.

NEPTUNE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24

NEPTUNE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Priovant Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

225 Total Patients Enrolled

Brendan Johnson, PhDStudy DirectorSVP, Early Development

Media Library

Intermediate Uveitis Clinical Trial 2023: Brepocitinib Highlights & Side Effects. Trial Name: NCT05523765 — Phase 2

Frequently Asked Questions

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

Could I possibly be a candidate for this program?

"This study is investigating polyarteritis nodosa and thus requires participants that have been diagnosed with the condition. Furthermore, individuals must be between 18-74 years old to qualify. In total, the clinical trial needs 24 patients."

Answered by AI

Is this research looking for more participants?

"That is accurate. As of right now, the study detailed on clinicaltrials.gov is recruiting patients. This trial was originally posted on November 1st, 2022 and updated just a few days ago on the 4th. They are looking for 24 individuals to participate at 12 different locations."

Answered by AI

Are there any documented risks associated with Brepocitinib?

"Since this is a Phase 2 trial, there is only preliminary data supporting the safety of Brepocitinib. It received a score of 2."

Answered by AI

Does this research only include middle-aged adults?

"According to the study's eligibility requirements, people aged 18-74 are able to apply to participate. There are 12 separate trials for individuals younger than 18 and 33 different ones for seniors."

Answered by AI

Is this clinical trial being conducted at multiple hospitals in Canada?

"There are 15 total sites for this trial, but the primary locations are Retina Associates of Utah in Salt Lake City, UT; Retina Consultants of Texas an RCA Company in Plano, TX; and Massachusetts Eye Research and Surgery Institute (MERSI) in Bellaire, NJ."

Answered by AI

How many people are signing up for this clinical trial?

"In order to carry out this study, 24 individuals that fit the specified profile are required. The sponsor - Priovant Therapeutics, Inc.- will be managing the clinical trial from various locations, two of which being Retina Associates of Utah in Salt Lake City and Retina Consultants of Texas an RCA Company based in Plano."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis

2022. "A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05523765.

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