Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss

Status unconfirmed · Early Phase 1

Conditions studied: Autoimmune Neurosensory Hearing Loss (ANSHL)

In brief

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

Key facts

Study ID

NCT02828033

Run by

Stanley Cohen

People needed

10

Starts

2017-02-01

Expected to finish

2018-03-01

Last updated by the study team

2017-09-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The presence of progressive sensironeural hearing loss greater than or equal to 30 dB in both ears at one or more frequencies (250, 500, 1000, 2000, 3000, 4000, 6000 or 8000 Hz) and idiopathic-based on clinical evaluation, blood tests, and radiographic imaging.
• Documented improvement in hearing by audiogram after 30 days of treatment with high dose prednisone 40-60 mg/d. Improvement is defined by 10 dB improvement in pure tone average (500-3000 dB) or an improvement in word identification score of at least 12% in either ear (both relative to baseline). Prednisone could be started at screening but patients may have received prednisone prior to screening and the pre prednisone audiogram will be used as the screening audiogram for this study. It is expected the majority of these patients will screen for the study in this fashion as they are referred from otoloaryngology after initial treatment.
• 18-75 years of age
• Able and willing to give written informed consent and comply with the requirements of the study protocol
• Negative serum pregnancy test (for women of child bearing potential). Males and Females of child bearing potential must agree to consistently use 2 forms of highly effective birth control (at least 1 of which must be a barrier method) starting at screening and throughout the study period and for 3 months after the final study drug administration.

You may not qualify if…

• Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug
• Have a known or suspected current active infection or a history of chronic or recurrent infectious disease including, but not limited to, chronic renal infection, chronic chest infections, chronic sinusitis, recurrent urinary tract infections, an open, draining, infected skin wound.
• Within 2 months of first study drug administration, have had a serious infection, have been hospitalized for an infection, have been treated with PO antibiotics for longer than 2 weeks, or have been treated with intravenous (IV) antibiotics for an infection
• Uncontrolled diabetes at the baseline visit (defined as HbA1c ≥9.0%)
• Patients requiring dialysis
• Patients who have had an organ transplant
• Treatment with any systemic {non-glucocorticoid} immunosuppressants (e.g. methotrexate, azathioprine, cyclosporine, mercaptopurine, mycophenolate mofetil, tacrolimus, sirolimus within 4 weeks of baseline rilonacept administration. No leflunomide treatment within 8 weeks prior to baseline administration. No etanercept, adalimumab, infliximab, tocilizumab, abatacept, or natalizumab, within 2 months prior to baseline visit; No rituxan for 12 months prior to baseline and evidence of normal B cell count required. Patients previously treated with anakinra for ANSHL cannot be enrolled.
• Prohibited Medications:
• Strong CYP3A4 inhibitors, protease inhibitors or P-gp inhibitors.
• Long-acting or extended release forms of opiates.
• Live or live-attenuated vaccines are excluded during the course of the study
• IA and IM glucocorticoid injections. Long-acting steroid preparations are not allowed during study (this includes suspensions and all forms of dexamethasone).
• History of a demyelinating disease or symptoms suggestive of multiple sclerosis
• Treatment with a live or live-attenuated virus vaccine during the 3 months prior to baseline
• Estimated glomerular filtration rate (eGFR) of <20 mL/min/1.73m2 or patients planning to start dialysis within a year from the screening visit
• Baseline laboratory test results meeting any of the following criteria:
• Hemoglobin (Hgb)<8.5 g/dL (85 g/L)
• Neutrophil count<1.5 x 103/μL
• Platelet count<100 x 103/μL
• Total bilirubin exceeding 1.5 times the upper limit of normal (ULN) unless consistent with Gilbert's syndrome
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 2 times the ULN
• Positive history of human immunodeficiency virus (HIV) by clinical or serological testing.
• Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (HCV) by serologic testing
• History of active TB prior to screening or chest x-ray showing evidence of malignancy or any abnormalities suggestive of prior tuberculosis (TB) infection, including, but not limited to, apical scarring, apical fibrosis, or multiple calcified granulomata.
• A positive intradermal skin tuberculin test (purified protein derivative [PPD] 5 tuberculin unit [TU]) of ≥5 mm induration read at 48 to 72 hours or positive QuantiFERON-gold testing. Signs or symptoms suggestive of active TB (e.g. new cough lasting >14 days or a change in chronic cough, persistent fever, unintentional weight loss, night sweats) upon review of medical history and/or physical examination. If the patient is thought to have a false-positive PPD because of prior BCG vaccination and it is known that the patient has been negative on testing obtained outside the protocol for M. tuberculosis infection using a cell-based interferon gamma assay the patient is eligible for enrollment.

Where it is running

• Metroplex Clinical Research Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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