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Monoclonal Antibodies

Ixekizumab for Refractory Uveitis

Phase 4

Recruiting

Led By C. Stephen Foster, MD, FACS, FACR

Research Sponsored by Massachusetts Eye Research and Surgery Institution

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Diagnosis of non-infectious intermediate, posterior, panuveitis, or chronic steroid dependent anterior uveitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial evaluates a new treatment for certain types of uveitis that haven't responded to other drugs.

Who is the study for?

Adults with non-infectious uveitis (intermediate, posterior, panuveitis, or chronic steroid-dependent anterior uveitis) who didn't respond to certain DMARDs or anti-TNF drugs. Participants must have active eye inflammation and not be planning cataract surgery soon. They can't join if they've had recent corticosteroid implants/injections, certain eye conditions/surgeries, severe infections, other clinical trial participation recently, major surgeries planned/just done, live vaccine received within a month before the trial starts.Check my eligibility

What is being tested?

The study is testing Ixekizumab Prefilled Syringe's effectiveness in treating refractory non-infectious uveitis compared to previous treatments that failed such as classic synthetic DMARDs and anti-TNF agents. It aims to see if this new treatment can manage the condition better.See study design

What are the potential side effects?

Ixekizumab may cause allergic reactions similar to other humanized monoclonal antibodies; it could also potentially affect organ systems leading to symptoms like fatigue or digestive issues. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a type of eye inflammation not caused by an infection.

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I have tried and not responded to at least one standard rheumatoid arthritis medication or one anti-TNF drug.

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My disease is currently active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Clinical response

Secondary outcome measures

Adverse Event frequency

Intraocular pressure

Subjective Visual Benefit

Side effects data

From 2015 Phase 3 trial • 204 Patients • NCT01777191

Upper respiratory tract infection

Injection site reaction

Supraventricular tachycardia

Colitis

Gastric ulcer haemorrhage

Cardio-respiratory arrest

Cholecystitis

Cellulitis

Diverticulitis

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

80 mg Ixe Prefilled Syringe Optional Safety Extension

Follow Up Period

80 mg Ixekizumab Prefilled Syringe Treatment Period

80 mg Ixekizumab Auto-Injector Treatment Period

Trial Design

2Treatment groups

Experimental Treatment

Group I: 4-week dosingExperimental Treatment1 Intervention

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.

Group II: 2-week dosingExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixekizumab Prefilled Syringe

2013

Completed Phase 3

~210

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts Eye Research and Surgery InstitutionLead Sponsor

Eli Lilly and CompanyIndustry Sponsor

2,620 Previous Clinical Trials

3,216,579 Total Patients Enrolled

C. Stephen Foster, MD, FACS, FACRPrincipal InvestigatorFounder of research site

Frequently Asked Questions

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

Are there any unfilled positions available for participants in this trial?

"According to clinicaltrials.gov, this research is seeking participants with the trial first published on June 1st 2022 and last edited October 11th 2023."

Answered by AI

What adverse effects are associated with a two-week course of treatment?

"The two-week dosing regimen has been sanctioned by the relevant medical board, and thus earned a rating of 3 on our team's safety scale."

Answered by AI

How many volunteers are being recruited to participate in this clinical research?

"Affirmative. Clinicaltrials.gov provides evidence that, since its inception on June 1st 2022, this clinical trial is actively seeking participants for recruitment. Twenty individuals are required to partake in the experiment at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085079.

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