Study of CYR-064 Versus Placebo in Patients.

February 16, 2024 updated by: Cyrano Therapeutics, Inc.

A Randomized, Double-Blinded, Placebo-Controlled Trial to Determine The Safety and Efficacy of CYR-064

Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine the safety and effectiveness of CYR-064 in a randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR064.

The study will take approximately 32 weeks which will include a 4-week screening period to evaluate if participants are right for the Study, followed by a 24-week Treatment Period, and a 1 week follow up after participants have completed the Study. About 150 subjects will participate in this study in about 25 research sites in the United States.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80923
        • Recruiting
        • Colorado ENT & Allergy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bryan Davis, MD
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Recruiting
        • ENTAAFL
        • Contact:
        • Contact:
          • Phone Number: 561-414-3816
        • Principal Investigator:
          • Nathan Nachlas, MD
      • Plantation, Florida, United States, 33324
        • Recruiting
        • ENTAAFL
        • Contact:
        • Principal Investigator:
          • Jon Rosenthal, MD
      • Port Saint Lucie, Florida, United States, 34952
        • Recruiting
        • ENTAAFL
        • Principal Investigator:
          • John Lanza, MD
        • Contact:
        • Contact:
          • Phone Number: 119 772-398-9911
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Active, not recruiting
        • Rush University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-8500
        • Recruiting
        • KU Medical Center-University of Kansas
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer Villwock, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40220
        • Recruiting
        • Advanced ENT and Allergy
        • Contact:
        • Principal Investigator:
          • Amy Ingram, MD
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Kentuckian ENT
        • Contact:
        • Principal Investigator:
          • Thomas Higgins, MD
    • Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Centers for Advanced ENT
        • Contact:
        • Principal Investigator:
          • Douglas Reh, MD
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina-MUSC
        • Contact:
        • Principal Investigator:
          • Rodney Schlosser, MD
        • Sub-Investigator:
          • Shaun Nguyen, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist
        • Contact:
        • Principal Investigator:
          • Mas Takashima, MD
    • Washington
      • Puyallup, Washington, United States, 98374
        • Recruiting
        • Ear Nose Throat & Allergy Associates
        • Principal Investigator:
          • Greg Davis, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Able to provide written informed consent.
  • Male or female 18-65 years of age.
  • Endoscopy of the nasal cavity showing no structural or pathologic issues leading to hyposmia (nasal polyps, sinusitis, infection, etc.) that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
  • CT scan of the nasal cavity after the onset of hyposmia (within prior 2 years) prior to Baseline showing no structural or pathologic issue leading to hyposmia that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
  • Willing and able to self-administer the study drug, follow the study drug administration instructions, comply with study procedures, and participate in the scheduled study visits specified in this protocol.

Exclusion Criteria:

  • History of traumatic brain injury, Parkinson's disease, early dementia, Alzheimer's disease, or any other condition in which hyposmia is not expected to improve in the opinion of the Investigator, such as history of congenital or idiopathic hyposmia or a surgical procedure that led to hyposmia.
  • History of surgery that led to hyposmia.
  • Concomitant Medical Conditions
  • Current symptoms or signs of an acute respiratory viral illness at Screening or Baseline.
  • Chronic viral infection or immunodeficiency condition (e.g., medical history of human immunodeficiency virus) based on medical records.
  • Any active malignancy.
  • Any concomitant medical condition that in the opinion of the Investigator, compromises patient safety or compliance with the study protocol or collected data.
  • History of moderate to severe Substance Use Disorder within the past 3 years as assessed by the Investigator.
  • History of persistent chronic sinusitis without polyps or chronic sinusitis with polyps.
  • Use or planned use of tobacco or nicotine-containing products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 3 months prior to Screening through EOS.
  • Unwilling or unable to discontinue current or planned use of over the counter or prescription medication administered intranasally, with the exception of nasal saline.
  • Use or planned use of another investigational drug within 4 weeks prior to Screening through Follow-Up.
  • Receiving any concomitant medication/therapy that would, in the opinion of the Investigator, compromise patient safety or compliance with the study protocol or collected data.
  • General Exclusions Any female who is pregnant, planning to become pregnant during the study, or who is lactating.

Vulnerable patients. Any condition or abnormality (including clinical laboratory, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator, would compromise the efficacy evaluation, safety of the patient, or would interfere with or complicate study procedures or assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CYR-064 dose 1
Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
Combination product: CYR-064
CYR-064 is a nasal solution.
Experimental: CYR-064 dose 2
Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
Combination product: CYR-064
CYR-064 is a nasal solution.
Placebo Comparator: Placebo
Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients.
Combination product: CYR-064
CYR-064 is a nasal solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome - Safety and Tolerability
Time Frame: Approximately 32 weeks
The count and percentage of patients reporting AEs, SAEs, and SUSARs will be summarized overall, by System Organ Class, Preferred Term within the System Organ Class, maximum severity, and relationship to study drug. All other safety parameters, including clinical laboratory values through blood draws, will be summarized using descriptive statistics for continuous variables and counts and percentages for categorical variables. All changes in nasal mucosal appearance will be noted.
Approximately 32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome-improvement on NRS-11 Smell-PRO
Time Frame: Approximately 24 weeks
Improvement in patient reported NRS-11 Smell-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.
Approximately 24 weeks
Secondary Outcome-improvement on NRS-11 Taste-PRO
Time Frame: Approximately 24 weeks
Improvement in patient reported NRS-11 Taste-PRO (scale of 0-10) in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.
Approximately 24 weeks
Secondary Outcome-Mean Change in NRS-11 Smell-PRO
Time Frame: Approximately 24 weeks
Mean Change in NRS-11 Smell-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 24
Approximately 24 weeks
Secondary Outcome-Mean Change in NRS-11 Taste-PRO
Time Frame: Approximately 24 weeks
Mean Change in NRS-11 Taste-PRO from Baseline to Week 24 between CYR-064 low and high dose and placebo from Baseline to Week 2
Approximately 24 weeks
Change in Visual Rating Scale (VRS) scores
Time Frame: Approximately 24 weeks

Change in Visual Rating Scale (VRS) scores in CYR-064 low dose and high dose groups as compared with placebo from Baseline to Week 24.

  • VRS high dose versus placebo
  • VRS low dose versus placebo
  • VRS low and high dose combined versus placebo
Approximately 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyrano Therapeutics, Inc.

Investigators

  • Principal Investigator: Mas Takashima, MD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYR-064-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Descriptive statistics

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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