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    Summary
    EudraCT Number:2020-004715-27
    Sponsor's Protocol Code Number:NOC100-C-201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2020-004715-27
    A.3Full title of the trial
    A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Two-Part Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetic Profiles of Inhaled Doses of NOC-100 in Adult Participants with Chronic Cough or Acute Cough, including Cough due to Postinfectious COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the effect of NOC-100 in terms of efficacy, safety, tolerability and drug levels in the blood in patients with acute and chronic cough.
    A.4.1Sponsor's protocol code numberNOC100-C-201
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNocion Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNocion Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNocion Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address100 Beaver Street, Suite 308
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA02453
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617803 2445
    B.5.6E-mailclinicaltrials@nociontx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNOC-100
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNTX-1175
    D.3.9.2Current sponsor codeNTX-1175
    D.3.9.3Other descriptive nameNTX-1175 chloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cough
    E.1.1.1Medical condition in easily understood language
    Cough
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011224
    E.1.2Term Cough
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1:
    To evaluate the safety and tolerability of escalating nebulised inhaled doses of NOC 100 (single and 2 consecutive QD doses) in participants with CC.

    Part 2:
    To evaluate the treatment effect of nebulised inhaled doses of NOC 100 as determined by VAS score for cough severity in participants with AC.

    To evaluate the safety and tolerability of nebulised inhaled doses of NOC 100 in participants with AC.
    E.2.2Secondary objectives of the trial
    Part 1:
    To evaluate the treatment effect of escalating nebulised inhaled doses of NOC 100 (single and 2 consecutive QD doses) as determined by awake-coughs per hour in participants with CC.

    To evaluate the treatment effect of escalating nebulised inhaled doses of NOC 100 (single and 2 consecutive QD doses) as determined by 24-hour coughs per hour in participants with CC.

    To characterise the PK profile of NOC 100 following escalating nebulised inhaled doses (single and 2-consecutive QD doses) in participants with CC.

    To identify the dose level and NOC 100 schedule for future development and administration in patients with CC.

    Part 2:
    To evaluate the treatment effect of nebulised inhaled doses of NOC 100 as determined by awake-coughs per hour and 24-hour coughs per hour in participants with AC.

    To characterise the PK profile of NOC 100 following nebulised inhaled doses in participants with AC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1:
    1. Male and female participants between the ages of 18 to 80 years, inclusive.
    2. Has had CC for ≥ 12 months and a diagnosis of refractory or unexplained CC (Per CHEST chronic cough diagnosis guidelines, Irwin et al, 2018).
    3. Chest radiograph or CT thorax within the timeframe supporting the diagnosis of CC, and within the last 60 months, not demonstrating any abnormality considered to be significantly contributing to the CC.
    4. If a female of childbearing potential, must be either sexually inactive (abstinent as a lifestyle*) for 28 days prior to the first dosing and throughout the study or using one of the following highly effective birth control methods:
    a. hormonal oral contraceptives, transdermal patch, or hormone-releasing intrauterine device for at least 3 months prior to the first dosing and with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study.
    b. Depot/implantable hormone (e.g., Depo Provera®, Implanon®) for at least 3 months prior to the first dosing and throughout the study.
    In addition, female participants of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 14 days after the last dose of study drug. Females will also be advised not to donate ova during the trial for at least 30 days after the last dose.
    *abstinence should only be used as a contraceptive method if it is in line with the participants’ usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception.
    5. If a female of non-childbearing potential, must have undergone one of the following sterilisation procedures at least 6 months prior to the first dosing:
    a. hysteroscopic sterilisation;
    b. bilateral salpingectomy;
    c. hysterectomy;
    d. bilateral oophorectomy or
    e. or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
    6. A non-vasectomised, male participant must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing. (No restrictions are required for a vasectomised male provided his vasectomy has been performed 4 months or more prior to the first dosing. A male who has been vasectomised less than 4 months prior to the first dosing must follow the same restrictions as a non-vasectomised male).
    7. If male, must agree not to donate sperm from the first dosing until 90 days after the last dosing.
    8. Understands the study procedures in the Informed Consent Form (ICF) and be willing and able to comply with the protocol. Participants must have signed and dated an IRB/IEC approved written ICF including all authorisations required by local law (e.g., collection and handling of personal data, especially health information). The ICF must be obtained before the performance of any protocol related procedures that are not part of the normal standard of care.
    9. Aspartate transaminase (AST) and alanine aminotransferase (ALT) <2 x upper limit of normal (ULN); alkaline phosphatase (ALP) and bilirubin ≤1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    10. Creatinine clearance ≥50 mL/min.
    11. Awake-cough frequency of ≥10 per hour (average) at Screening.
    12. Score of ≥40 mm on the Cough Severity VAS at Screening.
    E.4Principal exclusion criteria
    Part 1:
    1. Current smoker or individuals who have given up smoking within the past 6 months prior to screening, or those with >20 pack-year smoking history.
    2. Current diagnosis of COPD, bronchiectasis, unexplained pulmonary fibrosis, or asthma.
    3. History of concurrent malignancy or recurrence of malignancy in the 2 years prior to the screening visit, participants with adequately treated non-melanomatous skin carcinoma will be permitted.
    4. History of recent respiratory tract infection (including SARS-CoV-2 infection) or recent significant change in pulmonary status within 4 weeks of the screening visit.
    5. Is currently or has at any time had severe symptoms related to SARS-CoV-2 and required hospitalisation.
    6. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
    7. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
    8. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
    9. History of recent (within the past 6 months) acute myocardial infarction, acute thromboembolic event, myocarditis, hospitalization for unstable angina or heart failure; history or presence of a clinically important arrhythmia; Wolff-Parkinson-White syndrome or bundle branch block.
    10. History or presence of alcohol or drug use disorder, per DSM-5, within the past 2 years prior to screening.
    11. History or presence of hypersensitivity to the study drugs or related compounds.
    12. Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
    13. Current opiate/opioid use in the past 7 days prior to screening, or medical history of opiate/opioid use disorder (OUD).
    14. Unable to refrain from the use of:
    a. Gabapentin, pregabalin, and/or amitryptline or other tricyclics within 4 weeks prior to screening and throughout the study.
    b. Chronic, systemic corticosteroid use within 4 weeks prior to screening and throughout the study.
    c. Inhalers including long-acting and short acting beta 2 agonists (LABA, SABA) and ICS within 12 weeks prior to screening and throughout the study.
    d. Lidocaine or related compounds of any form within 14 days prior to screening and throughout the study.
    e. Medication or remedies to aid sleeping 14 days prior to screening and throughout the study.
    f. ACE-inhibitor within 12 weeks prior to screening and throughout the study.
    g. Antitussives 7 days prior to screening and throughout the study.
    h. Speech and language therapy for CC within 4 weeks prior to screening and throughout the study.
    i. Food and beverages containing xanthines/caffeine for 12 hours prior to screening (small amounts of caffeine derived from normal foodstuffs e.g., 250 mL/8 oz./1 cup decaffeinated coffee or other decaffeinated beverage, per day, with the exception of espresso; 45 g/1.5 oz. chocolate bar, per day, would not be considered a deviation to this restriction).
    j. Food and beverages containing alcohol for 24 h prior to screening.
    15. Donation of blood or plasma within 90 days prior to the first dosing.
    16. Participation in another clinical study involving an investigational drug within 60 days prior to the first dosing. The 60-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
    17. FEV1/FVC <the LLN at screening.
    18. Baseline ECG with QTcF interval with heart rate <40bpm, PR ≥ 220msec, QRS ≥120msec, ≥ 460 msec (males) or ≥470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening.
    19. Female participant with a positive pregnancy test at screening or positive pregnancy test at Baseline or lactating.
    20. Positive urine drug (not explained by current medical history or medications) or alcohol results at screening or Baseline.
    21. Positive cotinine results at screening or Baseline.
    22. Positive results at screening for HIV, hepatitis B surface antigen (HBsAg), or HCV (participants successfully treated for HCV may be permitted at the discretion of the PI).
    23. Seated BP is less than 90/40 mmHg or greater than 160/95 mmHg at screening. Vital signs may be repeated twice.
    24. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening. Vital signs may be repeated twice.
    25. Participant is unable to tolerate the bitter sensitivity solution mouthwash.
    26. Received the COVID-19 vaccine (any administration) within 14 days prior to the first dose of NOC-100. Participants scheduled for the COVID-19 vaccine (1st, 2nd, or booster administrations) during the study may be excluded at the discretion of the PI.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    Incidence of:
    - TEAEs,
    - SAEs,
    - severe AEs,
    AEs leading to study and/or treatment discontinuation.


    Part 2:
    Relative reduction in VAS score for cough severity
    Incidence of:
    - TEAEs,
    - SAEs,
    - severe AEs,
    - AEs leading to study and/or treatment discontinuation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to protocol for timepoints.
    E.5.2Secondary end point(s)
    Part 1:
    Relative reduction in awake cough frequency as determined by VitaloJAK®.
    Relative reduction in 24-hour cough frequency as determined by VitaloJAK®
    PK parameters following single doses within each dose level: AUC0 t, AUC0 inf, AUC%extrap, Cmax, Tmax, Kel, t½, CL/F (as appropriate), and Vz/F (as appropriate)
    NOC-100 dose and regimen for CC

    Part 2:
    Relative reduction in awake-cough and 24 hour cough frequency as determined by VitaloJAK®
    PK parameters following single doses within each dose level: AUC0 t, AUC0 inf, AUC%extrap, Cmax, Tmax, Kel, t½, CL/F (as appropriate), and Vz/F (as appropriate)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol for timepoints.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last scheduled study procedure.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-06
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