The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

XOMA

Status and phase: Completed; Phase 2

Conditions: Autoimmune Inner Ear Disease

Treatments: Drug: gevokizumab

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01950312

X052180

R33DC011827 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Autoimmune Inner Ear Disease with active deterioration in at least one ear
• Failure to respond to a trial of high-dose corticosteroid therapy
• Contraceptive measures adequate to prevent pregnancy during the study

Exclusion criteria

• Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct)
• History of active or chronic infections
• Currently receiving, or having received treatment for a malignancy in the past three years
• Hearing loss that coincides with significant, disabling episodes of vertigo
• History of allergic or anaphylactic reactions to monoclonal antibodies
• Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

gevokizumab

Experimental group

Description:

Solution for subcutaneous injection

Treatment:

Drug: gevokizumab