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    Summary
    EudraCT Number:2014-002052-84
    Sponsor's Protocol Code Number:STX-01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-18
    Trial results Removed from public view
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-002052-84
    A.3Full title of the trial
    An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Mild to Moderate Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate what effects FX125L (taken by mouth) has on adults with mild to moderate asthma
    A.4.1Sponsor's protocol code numberSTX-01
    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 SponsorSTX Pharma
    B.1.3.4CountryUnited Kingdom
    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 supportSTX Pharma
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSTX Pharma
    B.5.2Functional name of contact pointChief Operating Officer
    B.5.3 Address:
    B.5.3.1Street AddressBabraham Research Campus, Babraham,
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223834510
    B.5.6E-mailbob@stxpharma.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 nameFX125L
    D.3.2Product code FX125L
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeFX125L
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    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
    To estimate the effect of FX125L on forced expiratory volume in one second (FEV1) following oral delivery of FX125L for 8 weeks.
    E.2.2Secondary objectives of the trial
    • To determine the safety of once daily oral dosing with FX125L 600 mg for up to 8 weeks in patients with asthma
    • To estimate the effect of FX125L on additional markers of asthma symptoms and disease activity: Asthma Control Days and frequency of inhaled β-agonist rescue medication; Asthma Control Test score; Patient and Physician Global Assessment using a Visual Analog Scale; and sputum eosinophilia following oral delivery of FX125L for 8 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to give written informed consent and to comply with the requirements of the study.
    2. Male or female aged 18–77 years, inclusive.
    3. Body mass index 18–35 kg/m2, inclusive.
    4. Females of child-bearing potential must be using an adequate and medically acceptable contraception method as outlined in the protocol.
    5. Females of child-bearing potential must not be lactating or pregnant (negative serum beta-human chorionic gonadotropin on Screening or urine pregnancy test at Day -1 visit).
    6. Male patients must agree not to donate sperm, and to take appropriate precautions to avoid fathering a child, throughout the study and until 90 days after the end of treatment.
    7. Documented medical history of asthma at least 3 months prior to Screening, or equivalent that confirms the diagnosis meets this criteria.
    8. Forced expiratory volume in 1 second (FEV1) ≤90% of predicted at Screening and ≤92% of predicted on (Day -1).
    E.4Principal exclusion criteria
    1. Any condition, including findings in the medical history or in the pre-study assessments, which, in the opinion of the Investigator, constitute a risk or contraindication for the participation of the subject in the study, or that could interfere with the study objectives, conduct, or evaluation including, but not limited to:
    i. Any clinically significant abnormality in the results of screening safety laboratory tests.
    ii. Positive test for drugs of abuse at screening or Day -1.
    iii. Positive alcohol breath test at screening or Day -1.
    iv. Positive results from serum tests for hepatitis B surface antigen (HbAg) (except if due to vaccination), hepatitis C (HCV), or human immunodeficiency virus (HIV).
    v. History or presence of liver disease.
    vi. History or presence of endocrine disorders or diseases affecting the hypothalamic-pituitary-adrenal axis, including acromegaly, growth hormone deficiency, adrenal insufficiency, Cushing’s syndrome, Grave’s Disease, Hashimoto’s Disease, uncontrolled diabetes mellitus, with the exception of idiopathic hypothyroidism in patients over the age of 60 years.
    vii. History of hypofertility (males only)
    viii. History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and squamous cell carcinoma in situ of the skin)
    2. History or presence of drug or alcohol abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision.
    3. History of active manifestation of a serious psychiatric illness that in the opinion of the PI would deem a subject to be unsuitable for inclusion in the study including acute depression, suicidal ideation or psychosis.
    4. Positive test for latent tuberculosis.
    5. Requirement for immunisations or vaccinations within 7 days of any visit during the entire study period (including the screening, treatment and follow-up phases).
    6. Previous participation in the current study, or administration of any investigational product within 12 weeks (or at least 5 times the half-life of the product, if longer) prior to entry into the study.
    7. Acute infection requiring a visit to a doctor or hospital, or treatment with a prescription-only medication, within 2 weeks prior to Day 1.
    8. Any condition that may affect the absorption of an orally administered drug, for example, but not limited to, ulcerative colitis or resection of the stomach or small bowel.
    9. Required to take a proscribed drug (as defined in the protocol) during the study.
    10. History of treatment with corticosteroids within 1 month of screening, including inhaled steroids (with the exception of topical steroid creams containing 2% or less hydrocortisone).
    11. History of treatment with a biological anti-inflammatory therapy within 6 months of screening.
    12. History of exposure to FX125L.
    13. Received treatment with inhaled or oral asthma or allergy medications except β-agonists (e.g., corticosteroids, anti-histamines, leukotriene receptor antagonists, methylxanthines) within 4 weeks prior to Screening
    14. Suffer from respiratory diseases, other than asthma or allergic rhinitis, which would interfere with asthma disease assessments.
    15. Respiratory infections within 8 weeks prior to Day 1.
    16. Asthma exacerbation leading to hospitalisation for more than 2 days within the last 6 months or a hospital accident and emergency visit due to asthma exacerbation in the last 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean forced expiratory volume in one second (FEV1) from both pre-treatment visits (Screening and Day -1) compared to the mean from Day 10, Day 42 and Day 56 visits.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Forced expiratory volume in one second (FEV1): Screening, Day -1, Day 1, Day 10, Day 42, Day 56 and Day 84 (optional).
    E.5.2Secondary end point(s)
    • Full differential leukocyte count in blood
    • Full differential leukocyte count in sputum plugs
    • Asthma Control Days and frequency of inhaled β-agonist rescue medication throughout the study
    • Asthma Control Test score
    • Patient and Physician Global Assessment using a Visual Analog Scale

    Safety
    • Physical examination, vital signs, 12-lead Electrocardiogram (ECG), clinical laboratory assessments
    • Adverse events (AEs) throughout the study

    Endocrine
    Markers of endocrine function, including Total IGF-1, free T4, free T3, ACTH, TSH and FSH.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Full differential leukocyte count (blood): Screening, Day (D) -1, 10, 42, 56, & 84 & optionally at other time points
    • Full differential leukocyte count (sputum): Screening, D-1, 42 & 56 & optionally at D84
    • Asthma Control Days & freq of inhaled β-agonist rescue medication: Screening, D1, 10, 42 & 56
    • Asthma Control Test score: Screening, D -1, 42 & 56 & optionally at D84
    • Patient & Physician Global Assessment: Screening, D-1, 10, 42 & 56 & optionally at D84

    Safety
    • Physical examination, vital signs, 12-lead ECGs, clinical lab assessments: Screening, Day -1 (excl vitals & ECG), Day 1 (vitals & ECG only), Day 10, 42, 56 & 84
    • Adverse Events throughout the study

    Endocrine
    Markers of endocrine function: Screening, Day 10, 56 & 84
    Total IGF-1: Screening, Day -1, 42 & 56
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.6Cross over No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    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 months9
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state52
    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)
    Once they have completed the study, care of the subjects will return to either their GP or consultant and they will be treated as seems best according to these medical professionals. FX125L will not be provided after the study ends, however, subjects may be enrolled in future studies of this compound if they are eligible.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-12
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