Etanercept for Tinnitus

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen by Jinsheng Zhang, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Wayne State University

Must not be taking: Immunomodulatory biologics, Cyclophosphamide, Sulfonylureas, others

Disqualifiers: Diabetes, Seizure disorder, Auto-immune disease, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if Etanercept injections can help adults with noise-induced tinnitus by reducing inflammation. The study aims to see if it can lower tinnitus distress and loudness, and improve hearing.

Will I have to stop taking my current medications?

The trial requires a four-week period without any other tinnitus treatments before starting. Some medications, like cyclophosphamide, sulfasalazine, and certain diabetes and immunomodulatory drugs, are not allowed during the study.

What data supports the effectiveness of the drug Etanercept for treating tinnitus?

Etanercept has been shown to be effective in reducing inflammation in conditions like rheumatoid arthritis and psoriatic arthritis by blocking a protein called TNF-alpha, which is involved in inflammation. While there is no direct evidence for tinnitus, its success in other inflammatory conditions suggests potential benefits. ^{1 2 3 4 5}

Is Etanercept generally safe for humans?

Etanercept has been shown to be generally safe in humans, with minor side effects like injection site reactions and upper respiratory infections. However, caution is advised as it may reactivate tuberculosis and there are concerns about a potential link to lymphoma. ^{2 4 5 6 7}

How does the drug Etanercept differ from other treatments for tinnitus?

Etanercept is unique because it is a fusion protein that targets and binds to tumor necrosis factor-alpha (TNF-alpha), a molecule involved in inflammation, which is not a common approach for treating tinnitus. It is typically used for inflammatory conditions like rheumatoid arthritis, and its use for tinnitus is novel, as there are no standard treatments specifically targeting TNF-alpha for this condition. ^{2 4 5 6 8}

Research Team

Jinsheng Zhang, Ph.D.

Principal Investigator

Wayne State University

Eligibility Criteria

Adults with moderate to severe tinnitus from noise or blast exposure, or associated with traumatic brain injury (TBI) or concussion. Participants must be stable enough psychologically for the study, not have used other tinnitus treatments in the last four weeks, and able to consent. All hearing levels are included but those with profound loss can't do certain tests.

Inclusion Criteria

Able to provide written informed consent.

People with any level of hearing ability can join the study. However, individuals with severe hearing loss won't be able to do certain hearing tests.

Able to provide written informed consent

Exclusion Criteria

I am not currently taking abatacept, cyclophosphamide, sulfasalazine, or similar medications.

You currently have a problem with drugs or alcohol.

I am a woman of child-bearing age not using contraception or I am breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Etanercept or placebo injections weekly

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Exploratory

Exploratory investigations to identify factors influencing therapeutic effects

36 weeks

Treatment Details

Interventions

• Etanercept (Cytokine Inhibitor)

Trial Overview The trial is testing Etanercept (Enbrel), a medication given through injections, against a placebo (saline solution). The goal is to see if Etanercept can reduce the severity of tinnitus caused by loud noises or blasts. Participants will be randomly assigned to receive either Etanercept or placebo.

Participant Groups

Group I: Etanercept Injection Group Experimental Treatment 1 Intervention

Subjects will receive 2 X 25mg/ 1ml etanercept injection (experimental) weekly for 12 weeks.

Group II: Placebo Injection Group Placebo Group 1 Intervention

Subjects will receive 2 X 1ml saline injection (placebo) weekly for 12 weeks.

Etanercept is already approved in Canada for the following indications:

Approved in Canada as Enbrel for:

• Rheumatoid Arthritis
• Juvenile Idiopathic Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Plaque Psoriasis

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Amanda Bryant-Friedrich

Wayne State University

Chief Executive Officer since 2023

PhD in Pharmaceutical Sciences

Dr. Polsky

Wayne State University

Chief Medical Officer since 2023

MD from Wayne State University

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Dr. Afable

University of Iowa

Chief Medical Officer since 2005

MD from Loyola Stritch School of Medicine, MPH from the University of Illinois

Joel Harris

University of Iowa

Chief Executive Officer since 2023

B.A. in Economics from the University of Iowa, Post-baccalaureate Certificate in Narrative Communications from Northwestern University

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

Captain Morlock

United States Naval Medical Center, San Diego

Chief Executive Officer since 2023

Bachelor of Science in Biology from the University of South Dakota, MBA in 2001

Captain Elizabeth M. Adriano

United States Naval Medical Center, San Diego

Chief Medical Officer since 2023

MD

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Michigan Ear Institute

Collaborator

Trials

1

Recruited

90+

Madigan Army Medical Center

Collaborator

Trials

52

Recruited

17,600+

Portland VA Medical Center

Collaborator

Trials

44

Recruited

7,800+

Findings from Research

In a randomized, double-blind, placebo-controlled trial involving 234 patients with active rheumatoid arthritis, etanercept demonstrated significant improvements in disease activity over 6 months, with 59% of patients achieving a 20% improvement compared to only 11% in the placebo group.

Etanercept was well tolerated and showed a dose-dependent effect, with no dose-limiting toxic effects, confirming its safety and efficacy as a treatment for rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Moreland, LW., Schiff, MH., Baumgartner, SW., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Construction and purification of the murine p75-murine IgG1 fusion protein. [2016]

3. China pubmed.ncbi.nlm.nih.gov

[Recombinant human tumor necrosis factor receptor type Ⅱ-IgG Fc fusion protein for treatment of occupational medicamentosa-like dermatitis induced by trichloroethylene]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Etanercept in arthritis. [2015]

6. Italy pubmed.ncbi.nlm.nih.gov

Etanercept and urticaria in patients with juvenile idiopathic arthritis. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Pharmacodynamic effects of the murine p75-Fc fusion protein in mice. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Use of etanercept in human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) patients. [2015]