Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss

Overseen By Cindy Cabrera

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanley Cohen

Must be taking: Prednisone

Must not be taking: Immunosuppressants, CYP3A4 inhibitors

Disqualifiers: Infections, Diabetes, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

10 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you stop taking certain medications, including systemic immunosuppressants and specific drugs like strong CYP3A4 inhibitors and long-acting opiates, before starting the study. There are also restrictions on certain vaccines and steroid injections during the study.

What is the purpose of this trial?

This trial is testing rilonacept, a drug that reduces inflammation, on patients with progressive hearing loss in both ears. The goal is to see if reducing inflammation can help improve or stabilize their hearing.

Research Team

Stanley B Cohen, MD

Principal Investigator

Metroplex Clinical Research Center

Eligibility Criteria

Inclusion Criteria

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.

Able and willing to give written informed consent and comply with the requirements of the study protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a loading dose of 320 mg of rilonacept followed by a once-weekly injection of 160 mg for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Rilonacept

Participant Groups

Group I: Rilonacept Experimental Treatment 1 Intervention

A loading dose of 320 mg the first dose then be a once-weekly injection of 160 mg for 24 weeks

Who Is Running the Clinical Trial?

Stanley Cohen

Lead Sponsor

Trials

1

Recruited

10+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School