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Study of CYR-064 Versus Placebo in Patients.

Primary Purpose

Hyposmia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CYR-064
Sponsored by
Cyrano Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyposmia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Placebo Comparator

    Arm Label

    CYR-064 dose 1

    CYR-064 dose 2

    Placebo

    Arm Description

    Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.

    Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.

    Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients.

    Outcomes

    Primary Outcome Measures

    Primary Outcome - Safety and Tolerability
    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.

    Secondary Outcome Measures

    Secondary Outcome-improvement on NRS-11 Smell-PRO
    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.
    Secondary Outcome-improvement on NRS-11 Taste-PRO
    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.
    Secondary Outcome-Mean Change in NRS-11 Smell-PRO
    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
    Secondary Outcome-Mean Change in NRS-11 Taste-PRO
    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
    Change in Visual Rating Scale (VRS) scores
    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

    Full Information

    First Posted
    May 11, 2023
    Last Updated
    August 24, 2023
    Sponsor
    Cyrano Therapeutics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06019000
    Brief Title
    Study of CYR-064 Versus Placebo in Patients.
    Official Title
    A Randomized, Double-Blinded, Placebo-Controlled Trial to Determine The Safety and Efficacy of CYR-064
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 6, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    January 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cyrano Therapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyposmia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study treatment of CYR-064 is administered for a 24-week Treatment Period. Patients who meet all study criteria and have consented to participation will be randomized (1:1:1) to three parallel study arms, with two different dose strengths and a placebo group over 24 weeks. CYR-064 dose 1 CYR-064 dose 2 Placebo
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    There will be a placebo match and blinded randomization.
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CYR-064 dose 1
    Arm Type
    Active Comparator
    Arm Description
    Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
    Arm Title
    CYR-064 dose 2
    Arm Type
    Experimental
    Arm Description
    Treatment with nasal solution of CYR-064 twice a day for 24 weeks. CYR-064 will be self-administered by patients.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Treatment with Placebo nasal solution for 24 weeks. CYR-064 will be self-administered by patients.
    Intervention Type
    Combination Product
    Intervention Name(s)
    CYR-064
    Intervention Description
    CYR-064 is a nasal solution.
    Primary Outcome Measure Information:
    Title
    Primary Outcome - Safety and Tolerability
    Description
    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.
    Time Frame
    Approximately 32 weeks
    Secondary Outcome Measure Information:
    Title
    Secondary Outcome-improvement on NRS-11 Smell-PRO
    Description
    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.
    Time Frame
    Approximately 24 weeks
    Title
    Secondary Outcome-improvement on NRS-11 Taste-PRO
    Description
    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.
    Time Frame
    Approximately 24 weeks
    Title
    Secondary Outcome-Mean Change in NRS-11 Smell-PRO
    Description
    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
    Time Frame
    Approximately 24 weeks
    Title
    Secondary Outcome-Mean Change in NRS-11 Taste-PRO
    Description
    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
    Time Frame
    Approximately 24 weeks
    Title
    Change in Visual Rating Scale (VRS) scores
    Description
    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
    Time Frame
    Approximately 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Descriptive statistics
    Citations:
    Citation
    Henkin RI. Growth Factors in Olfaction. In: Preedy VR, editor. Handbook of Growth and Growth Monitoring in Health and Disease. New York, NY: Springer New York; 2012. p. 1417-36.
    Results Reference
    background
    Citation
    Henkin RI, Abdelmeguid M. Improved Smell and Taste Dysfunction with Intranasal Theophylline. Am J Otolaryngol Head Neck Surg. 2019;2(9):1070.
    Results Reference
    background
    PubMed Identifier
    23731850
    Citation
    Henkin RI, Levy LM, Fordyce A. Taste and smell function in chronic disease: a review of clinical and biochemical evaluations of taste and smell dysfunction in over 5000 patients at The Taste and Smell Clinic in Washington, DC. Am J Otolaryngol. 2013 Sep-Oct;34(5):477-89. doi: 10.1016/j.amjoto.2013.04.006. Epub 2013 Jun 2.
    Results Reference
    result
    PubMed Identifier
    22377744
    Citation
    Henkin RI. Comparative monitoring of oral theophylline treatment in blood serum, saliva, and nasal mucus. Ther Drug Monit. 2012 Apr;34(2):217-21. doi: 10.1097/FTD.0b013e3182492a20.
    Results Reference
    result
    PubMed Identifier
    27923495
    Citation
    Henkin RI, Hosein S, Stateman WA, Knoppel AB, Abdelmeguid M. Improved smell function with increased nasal mucus sonic hedgehog in hyposmic patients after treatment with oral theophylline. Am J Otolaryngol. 2017 Mar-Apr;38(2):143-147. doi: 10.1016/j.amjoto.2016.11.010. Epub 2016 Nov 23.
    Results Reference
    result
    PubMed Identifier
    23165381
    Citation
    Henkin RI, Schultz M, Minnick-Poppe L. Intranasal theophylline treatment of hyposmia and hypogeusia: a pilot study. Arch Otolaryngol Head Neck Surg. 2012 Nov;138(11):1064-70. doi: 10.1001/2013.jamaoto.342.
    Results Reference
    result
    PubMed Identifier
    18377764
    Citation
    Henkin RI, Velicu I. cAMP and cGMP in nasal mucus related to severity of smell loss in patients with smell dysfunction. Clin Invest Med. 2008;31(2):E78-84. doi: 10.25011/cim.v31i2.3367.
    Results Reference
    result
    PubMed Identifier
    19359985
    Citation
    Henkin RI, Velicu I, Schmidt L. An open-label controlled trial of theophylline for treatment of patients with hyposmia. Am J Med Sci. 2009 Jun;337(6):396-406. doi: 10.1097/MAJ.0b013e3181914a97.
    Results Reference
    result
    PubMed Identifier
    21191261
    Citation
    Henkin RI, Velicu I, Schmidt L. Relative resistance to oral theophylline treatment in patients with hyposmia manifested by decreased secretion of nasal mucus cyclic nucleotides. Am J Med Sci. 2011 Jan;341(1):17-22. doi: 10.1097/MAJ.0b013e3181f1fdc8.
    Results Reference
    result

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    Study of CYR-064 Versus Placebo in Patients.

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