26 Participants Needed

Brepocitinib for Uveitis

(NEPTUNE Trial)

Recruiting at 21 trial locations
CT
Overseen ByClinical Trial Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Priovant Therapeutics, Inc.
Must be taking: Immunomodulatory therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial allows participants to be on one non-corticosteroid, non-biologic, immunomodulatory therapy, so you may need to adjust your current medications to meet this requirement.

What data supports the effectiveness of the drug Brepocitinib for treating uveitis?

Research shows that other drugs like tofacitinib and certolizumab pegol have been effective in treating uveitis, suggesting that similar treatments targeting inflammation might also be beneficial for this condition.12345

How is the drug Brepocitinib unique for treating uveitis?

Brepocitinib is unique because it is a janus kinase inhibitor (JAK-I), which is a type of drug that blocks specific enzymes involved in inflammation, potentially offering a new approach for treating uveitis compared to traditional treatments like corticosteroids or other immunosuppressants.26789

What is the purpose of this trial?

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.

Research Team

BJ

Brendan Johnson, PhD

Principal Investigator

SVP, Early Development

Eligibility Criteria

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.

Inclusion Criteria

I weigh more than 40 kg and my BMI is less than 40.
I have been diagnosed with a type of uveitis that is not caused by an infection.
I have active inflammation in my eye, confirmed by a doctor.
See 1 more

Exclusion Criteria

I have inflammation in the front part of my eye.
I am at high risk for shingles reactivation.
I have a history of cancer.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral brepocitinib for the treatment of non-infectious uveitis

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Brepocitinib
Trial Overview 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Brepocitinib Dose Level 2 PO QDExperimental Treatment1 Intervention
Group II: Brepocitinib Dose Level 1 PO QDExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Priovant Therapeutics, Inc.

Lead Sponsor

Trials
4
Recruited
570+

Findings from Research

In a study of 7 patients with chronic-relapsing uveitis who had previously failed other treatments, 71.4% achieved quiescence after 10.4 months of treatment with certolizumab pegol (CZP).
Visual acuity improved significantly after 1 and 6 months of treatment, and no adverse events were reported, indicating that CZP is a safe and effective option for refractory uveitis.
Certolizumab Pegol, a New Anti-TNF-α in the Armamentarium against Ocular Inflammation.Llorenç, V., Mesquida, M., Sainz de la Maza, M., et al.[2022]
Tofacitinib was successfully used to treat two patients with refractory uveitis and scleritis, conditions that did not respond to multiple steroid-sparing therapies.
The treatment resulted in a durable resolution of both uveitis and scleritis, suggesting that tofacitinib could be a promising new option for managing severe inflammatory eye diseases.
Tofacitinib for refractory uveitis and scleritis.Paley, MA., Karacal, H., Rao, PK., et al.[2022]
A 61-year-old woman experienced recurrent uveitis after starting treatment with the cancer drugs dabrafenib and pembrolizumab for metastatic melanoma, highlighting a potential safety concern with these therapies.
This case is notable as it documents the occurrence of acute uveitis in the same patient after sequential treatment with both a targeted therapy (dabrafenib) and an immune checkpoint inhibitor (pembrolizumab), suggesting a need for monitoring eye health in patients receiving these medications.
A case of recurrent bilateral uveitis independently associated with dabrafenib and pembrolizumab therapy.Taylor, SC., Hrisomalos, F., Linette, GP., et al.[2022]

References

Certolizumab Pegol, a New Anti-TNF-α in the Armamentarium against Ocular Inflammation. [2022]
Tofacitinib for refractory uveitis and scleritis. [2022]
A case of recurrent bilateral uveitis independently associated with dabrafenib and pembrolizumab therapy. [2022]
Efficacy and safety of certolizumab pegol and golimumab in the treatment of non-infectious uveitis. [2019]
Anti-interleukin 6 receptor tocilizumab in refractory uveitis associated with Behçet's disease: multicentre retrospective study. [2018]
Mycophenolate mofetil for the treatment of uveitis. [2022]
Vogt-Kayanagi-Harada-Like Uveitis Induced by Dabrafenib/Trametinib Therapy for Cutaneous Malignant Melanoma. [2023]
Mycophenolate mofetil as an immunomodulator in refractory noninfectious uveitis. [2022]
Beneficial Effect of Upadacitinib in an Adult Patient with Juvenile Idiopathic Arthritis-associated Uveitis after Unsatisfactory Response to Tofacitinib: A Case Report. [2023]
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