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Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss

NCT02828033 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-09-13

No results posted yet for this study

Summary

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

Conditions

  • Autoimmune Neurosensory Hearing Loss (ANSHL)

Interventions

DRUG

Rilonacept

All patients will receive rilonacept with an initial loading dose of 320 mg delivered as two, 2-mL, subcutaneous injections of 160 mg each given on the same day at two different sites. The initial dose will be administered at the study site by study personnel. Dosing will then be a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection by the patient at home. Patients will be dosed for 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • Stanley B Cohen, MD · Metroplex Clinical Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-03-31
Completion
2018-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828033 on ClinicalTrials.gov