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    Summary
    EudraCT Number:2012-003147-30
    Sponsor's Protocol Code Number:1103-CT02
    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:2012-11-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003147-30
    A.3Full title of the trial
    A Phase II Randomised, Open-Label, Parallel Group Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Two Subcutaneous Dosing Regimens of ATL1103 in Adult Patients with Acromegaly.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to assess whether the new drug ATL1103 is safe and effective in patients who have acromegaly
    A.4.1Sponsor's protocol code number1103-CT02
    A.5.4Other Identifiers
    Name:Australian New Zealand Clinical Trials RegistryNumber:ACTRN12612000989842
    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 SponsorAntisense Therapeutics Ltd
    B.1.3.4CountryAustralia
    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 supportAntisense Therapeutics Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntisense Therapeutics Ltd
    B.5.2Functional name of contact pointScientific Project Manager
    B.5.3 Address:
    B.5.3.1Street Address6 Wallace Avenue
    B.5.3.2Town/ cityToorak
    B.5.3.3Post code3142
    B.5.3.4CountryAustralia
    B.5.4Telephone number4439827 8999
    B.5.6E-mailinfo@antisense.com.au
    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 nameATL1103
    D.3.2Product code ATL1103
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATL1103
    D.3.9.1CAS number 872063-57-5
    D.3.9.2Current sponsor codeATL1103
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acromegaly
    E.1.1.1Medical condition in easily understood language
    Growth disorder
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000599
    E.1.2Term Acromegaly
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of ATL1103 in patients with acromegaly.

    To evaluate the single dose and multiple dose pharmacokinetic profiles of ATL1103 via the subcutaneous route in patients with acromegaly.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of two dosing regimens of ATL1103 on serum IGF-I levels in patients with acromegaly.

    To explore the effects of ATL1103 on the following parameters in patients with acromegaly:
    -GH, GHBP
    -IGFBP-3, ALS, IGF-II
    -Ring size assessment
    -Signs and Symptoms Scale
    -Acromegaly Quality-of-Life questionnaire
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who:
    1. Provide written informed consent in accordance with local regulations.

    2. Are 18 to 80 years of age inclusive.

    3. Have acromegaly due to pituitary adenoma (micro or macro adenoma) identified by Magnetic Resonance Imaging (MRI).

    4. Have serum Insulin-like growth factor-1 (IGF-1) levels at Screening >1.3 times the upper limit of normal.

    5. Have nadir serum Growth Hormone (GH) levels > 1ng/mL at all test time points within the 2 hours post oral glucose load for an oral glucose tolerance test.

    6. Are acromegaly treatment naïve, or who have not taken other acromegaly medications for the following periods of time prior to IGF-1 and GH Screening tests:
    • Bromcriptine: 6 weeks
    • Carbergoline: 8 weeks
    • Quinagolide: 8 weeks
    • Octreotide (subcutaneous): 4 weeks
    • Pegvisomant: 8 weeks
    • Octreotide LAR: 4 months
    • Lanreotide (all presentations): 4 months
    Note: patients on medications may washout after consenting.

    7. Have a body mass index (BMI) ≥19 kg/m2.

    8. Have adequate venous access to allow collection of multiple blood samples during the study.

    9. Are female of non-child-bearing potential (i.e. either surgically sterilised or at least one year post-menopausal), or if of child-bearing potential, must agree to use two approved methods of contraception for the duration of the study and for three months after administration of the last dose of study drug

    OR

    Are male and surgically sterilized or agree to use an approved method of contraception for the duration of the study and until three months after administration of the last dose of the study medication.

    10. Are willing and able to self-administer subcutaneous injections.
    E.4Principal exclusion criteria
    Patients who:
    1. Have acromegaly due to reasons other than pituitary adenoma.

    2. Have a pituitary adenoma that is less than 3mm distance from the optic chiasm.

    3. Have undergone pituitary surgery within the 3 months preceding the Screening visit.

    4. Have received pituitary radiotherapy within the 3 years preceding the Baseline visit.

    5. Have insulin-treated diabetes.

    6. Have congestive heart failure, unstable angina, clinically significant cardiac arrhythmia, or a history of acute myocardial infarction within the 3 months preceding the Baseline visit.

    7. Have abnormal hepatic function at Screening defined as aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, prothrombin time or total bilirubin above 2 x the upper limit of normal.

    8. Have hepatitis B, hepatitis C, or chronic liver disease.

    9. Are pregnant or lactating.

    10. Have known human immunodeficiency virus (not tested specifically for this protocol), or history of immunodeficiency that may compromise their safety or affect results from this study.

    11. Have a history of alcohol or drug abuse in the 6 month period preceding the Baseline visit.

    12. Have participated in any clinical investigation with an investigational drug within 3 months (4 months if the drug is a new chemical entity) preceding the Baseline visit or during the washout period.

    13. Have renal impairment with serum creatinine > or = 2.0 mg/dl (177 µmol/L).

    14. Have a history of clinically relevant gastrointestinal, hepatic, renal, endocrine (other than acromegaly), haematological, metabolic, neurologic or psychiatric disease that in the investigator’s opinion may compromise their safety or effect results from this study.

    15. Have a history of clinically significant coagulation abnormalities or complement fragment Bb abnormalities.

    16. Have a history of severe or life-threatening drug allergy and/or known drug hypersensitivity.

    17. Are unable to communicate or cooperate with the Investigator due to language problem, poor mental development or impaired cerebral function.

    18. Have any other medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study, or are otherwise unsuitable for participation.

    19. Are unable to have a MRI performed due to metal residing in the body e.g. implants, cardiac pacemaker, valves, cochlear implants, central nervous system vascular clips etc.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability Endpoints
    - Incidence of Adverse Events
    - Safety laboratory parameters, including haematology, biochemistry, coagulation, Complement Bb, GH, urinalysis
    - Changes in vital signs
    - Changes in 12-lead ECGs
    - Pituitary tumour size changes
    - Incidence and severity of injection site reactions

    Pharmacokinetic Endpoints
    - Determination of Cmax, Cmin, Tmax ,T1/2 and AUC of ATL1103
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety
    - throughout treatment period (Day 1 to Week 14)
    - during follow up period (Week 14 - Week 21)

    Pharmacokinetics
    - from pre and post dose serum samples at various dosing time points during 21 week study period
    E.5.2Secondary end point(s)
    Primary Efficacy Endpoints
    - Percentage change in IGF-I levels at Week 14 compared with Baseline

    Secondary Efficacy Endpoints
    - The proportion of patients whose IGF-I levels are normalised at Week 14.
    - The proportion of patients whose IGF-I levels are normalised at any time point after baseline.
    - The mean change in IGF-I from baseline to week 14.
    - Change in GHBP, IGFBP-3, ALS, and IGF-II levels compared with Baseline.
    - Change in Signs and Symptoms questionnaire compared with Baseline.
    - Change in size of finger (as measured by the ring size assessment) at Week 14 compared to Baseline.
    - Change in AcroQoL questionnaire at Week 14 compared to Baseline.
    - Changes in GH, glucose and insulin from Screening OGTT to Week 14 OGTT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 14 compared to Baseline
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different treatment schedule of the same investigational product (ATL1103)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-12
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