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Interleukin-1 inhibitor
Rilonacept for Autoimmune Hearing Loss
Phase < 1
Waitlist Available
Led By Stanley B Cohen, MD
Research Sponsored by Stanley Cohen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing rilonacept, a drug that reduces inflammation, on patients with progressive hearing loss in both ears. The goal is to see if reducing inflammation can help improve or stabilize their hearing.
Eligible Conditions
- Autoimmune Hearing Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement in hearing in comparison to baseline values
Secondary study objectives
Pt reported evaluation of auditory acuity
Quality of Life assessment
Tinnitus evaluation
+1 moreSide effects data
From 2014 Phase 4 trial • 42 Patients • NCT0166310314%
upper respiratory infection
5%
Injection site reaction
5%
Neck abscess/pyomyositis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rilonacept
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: RilonaceptExperimental Treatment1 Intervention
A loading dose of 320 mg the first dose then be a once-weekly injection of 160 mg for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rilonacept
FDA approved
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsIndustry Sponsor
667 Previous Clinical Trials
386,003 Total Patients Enrolled
Stanley CohenLead Sponsor
Stanley B Cohen, MDPrincipal InvestigatorMetroplex Clinical Research Center
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