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

NCT06085079 | Unknown Phase 4 FDA Drug

• 1 other identifier: IXE-1001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis

Outcome Measures

Primary Outcomes (1)

• Clinical response

  The four components of the composite endpoint will each be graded dichotomously (i.e., yes, or no for success), and include visual acuity, control of inflammation, tapering of medication therapy, and reduction of cystoid macular edema. Clinical response will be defined by improvement in at least one parameter with worsening in none, and well controlled intraocular inflammation.

  Assessed around week 10

Secondary Outcomes (3)

• Intraocular pressure

  This will be measured and assessed throughout the entire 24-week study period up until the patient's final visit.

• Subjective Visual Benefit

  This will be measured and assessed throughout the entire 24-week study period up until the patient's final visit.

• Adverse Event frequency

  This will be monitored and assessed throughout the entirety of the 24-week study period and through 30 days following the last administration of study treatment.

Study Arms (2)

2-week dosing

EXPERIMENTAL

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.

Drug: Ixekizumab Prefilled Syringe

4-week dosing

EXPERIMENTAL

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.

Drug: Ixekizumab Prefilled Syringe

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.

2-week dosing; 4-week dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid dependent anterior uveitis
• Failure of at least one classic synthetic DMARD including Methotrexate, Mycophenolate, Cyclosporin, Azathioprine, Cyclophosphamide, and/or at least one anti-TNF agent including Adalimumab, Infliximab, Etanercept, Golimumab or Certolizumab
• Active disease at screening visit
• At least 1 of the following parameters in at least one eye:
• active inflammatory chorioretinal and/or inflammatory retinal vascular lesions
• ≥ 1+ vitreous haze (Nussenblatt criteria)
• ≥ 2+ anterior chamber cells (National Eye Institute/Standardization of Uveitis Nomenclature criteria)
• Cystoid macular edema, seen on optical coherence tomography and/or fluorescein angiography
• FA leakage pattern deemed by investigators to be suggestive of active intermediate, posterior, and panuveitis, including optic disc, retinal vascular, and macular leakages
• Active snowbanking

You may not qualify if:

• The presence of only acute anterior uveitis.
• Serpiginous choroidopathy
• Subject with prior inadequate response to high-dose oral corticosteroids (\> 60 mg of prednisone)
• Subject with confirmed or suspected infectious uveitis
• Patients with intraocular pressure of ≥ 25 mmHg or evidence of optic nerve injury
• Corneal or lens opacity that precludes adequate ophthalmic evaluation.
• Patients likely to undergo cataract surgery during the duration of the trial.
• Patients with Best Corrected Visual Acuity (BCVA) less than 20 letters (Early Treatment Diabetic Retinopathy Study)
• Dose of concomitant immunosuppressive therapy at the baseline visit:
• Methotrexate (MTX) ˃ 25 mg per week
• Cyclosporine ˃ 4 mg/kg per day
• Mycophenolate mofetil ˃ 3 grams per day or an equivalent drug to mycophenolate mofetil (e.g. mycophenolic acid) at an equivalent dose approved by the medical monitor.
• Azathioprine ˃ 175 mg per day
• Tacrolimus (oral formulation) \> 8 mg per day
• If entering the study on 1 concomitant immunosuppressive therapy, dose has been increased within the last 28 days prior to Baseline visit.

Sponsors & Collaborators

• Massachusetts Eye Research and Surgery Institution: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Massachusetts Eye Research and Surgery Institution

Waltham, Massachusetts, 02451, United States

RECRUITING

MeSH Terms

Conditions

Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis

Condition Hierarchy (Ancestors)

Uveitis; Uveal Diseases; Eye Diseases

Study Officials

• C. Stephen Foster, MD, FACS, FACR

  Founder of research site

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tate Valerio, BA

CONTACT

781-891-6377; tvalerio@mersi.com

Yasmin Massoudi, BA

CONTACT

781-891-6377; ymassoudi@mersi.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: 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. Arm 2: 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.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: October 16, 2023
• Study Start: June 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (1)