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

Part of paid clinical trials in Waltham, Massachusetts.

Sponsor
Massachusetts Eye Research and Surgery Institution
Study ID
NCT06085079
Phase
PHASE4
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ixekizumab Prefilled Syringe — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Oct 2023
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2-week dosing
    Subjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q2 weeks for 24-weeks.
  • Experimental: 4-week dosing
    Subjects will self-administer subcutaneous injection of ixekizumab during the baseline week (Week 0) using a loading dose of 160 mg of subcutaneous ixekizumab (Taltz), followed by 80 mg of subcutaneous ixekizumab Q4 weeks for 24-weeks.

Primary Outcome Measure

Clinical response [ Time Frame: Assessed around week 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye Research and Surgery InstitutionWalthamMassachusetts02451
Tate Valerio, BA
[email protected]
781-647-1431
Yasmin Massoudi, BS
[email protected]
7816471431
C. Stephen Foster (PRINCIPAL_INVESTIGATOR)
Stephen D Anesi (SUB_INVESTIGATOR)
Peter Y Chang (SUB_INVESTIGATOR)

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Massachusetts Eye Research and Surgery Institution· Waltham, MA

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