The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease (NCT01950312) | Clinical Trial Compass
CompletedPhase 2
The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
United States10 participantsStarted 2013-08
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score)