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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

Study Summary

This study is an open label proof of concept study of rilonacept for patients with ANSHL

Eligible Conditions
  • Autoimmune Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in hearing in comparison to baseline values
Secondary outcome measures
Pt reported evaluation of auditory acuity
Quality of Life assessment
Tinnitus evaluation
+1 more

Side effects data

From 2014 Phase 4 trial • 42 Patients • NCT01663103
14%
upper respiratory infection
5%
Injection site reaction
5%
Neck abscess/pyomyositis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rilonacept
Placebo

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
616 Previous Clinical Trials
379,835 Total Patients Enrolled
Stanley CohenLead Sponsor
Stanley B Cohen, MDPrincipal InvestigatorMetroplex Clinical Research Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Otology & NeurotologyJournal
Etanercept Therapy for Immune-mediated Cochleovestibular Disorders: Preliminary Results in a Pilot Study
Rahman, Mahboob U., Dennis S. Poe, and Hyon K. Choi. 2001. “Etanercept Therapy for Immune-mediated Cochleovestibular Disorders: Preliminary Results in a Pilot Study”. Otology & Neurotology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00129492-200109000-00010.
clinicaltrials.govStudy
Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss
Stanley Cohen 2017. "Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02828033.
All > Autoimmune Hemolytic Anemia > Hearing Loss
~1 spots leftby Apr 2025
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