NCT06085079

Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study

A 24-week Two-armed Proof-of-concept Exploratory Analysis of Subcutaneous Ixekizumab Administration in Patients With Recalcitrant Non-infectious Intermediate, Posterior, Panuveitis, or Chronic Steroid-dependent Anterior Uveitis.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Massachusetts Eye Research and Surgery Institution · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to explore the efficacy of ixekizumab in treating patients with a diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid-dependent anterior uveitis who had failed treatment with a classic synthetic DMARD including methotrexate, mycophenolate, cyclosporin, azathioprine, cyclophosphamide and/or at least one anti-TNF agent including adalimumab, infliximab, etanercept, golimumab or certolizumab.

Detailed description

This is a 24-week open label analysis of subcutaneous ixekizumab (taltz) in patients with non-infectious intermediate, posterior, panuveitis, and chronic steroid-dependent anterior uveitis. The study visits are held at Massachusetts Eye Research and Surgery Institution (MERSI) in Waltham, Massachusetts. The study is aiming to enroll 20 subjects. This is a two-armed study in which Group A receives ixekizumab every 2 weeks and Group B receives ixekizumab every 4 weeks.

Conditions

• Uveitis, Posterior
• Uveitis, Anterior
• Uveitis, Intermediate
• Panuveitis

Interventions

Type	Name	Description
DRUG	Ixekizumab Prefilled Syringe	Ixekizumab is a humanized IgG4 monoclonal antibody that binds with high affinity and specificity to IL-17A. This medication is currently approved for the treatment of plaque Ps, ankylosing spondylitis, and psoriatic arthritis.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2023-10-16
• Last updated: 2023-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study