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    Summary
    EudraCT Number:2021-000176-11
    Sponsor's Protocol Code Number:HMGLP2201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-07
    Trial 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-000176-11
    A.3Full title of the trial
    A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects with Short Bowel Syndrome-associated Intestinal Failure (SBS-IF) (DOLPHINS-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of HM15912 in subjects with Short Bowel Syndrome-associated Intestinal Failure
    A.3.2Name or abbreviated title of the trial where available
    DOLPHINS-2
    A.4.1Sponsor's protocol code numberHMGLP2201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04775706
    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 SponsorHanmi Pharmaceutical Co., Ltd.
    B.1.3.4CountryKorea, Republic of
    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 supportHanmi Pharmaceutical Co., Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHanmi Pharmaceutical Co., Ltd.
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address14, Wiryeseong-daero, Songpa-gu
    B.5.3.2Town/ citySeoul
    B.5.3.3Post code05545
    B.5.3.4CountryKorea, Republic of
    B.5.4Telephone number+822 410 9062
    B.5.5Fax number+822 410 9278
    B.5.6E-mailmhlee7@hanmi.co.kr
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2126
    D.3 Description of the IMP
    D.3.1Product nameHM15912 (LAPS GLP-2 analog)
    D.3.2Product code HM15912 (LAPS GLP-2 analog)
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNHuman glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment
    D.3.9.2Current sponsor codeHM15912
    D.3.9.3Other descriptive nameHuman glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment
    D.3.9.4EV Substance CodeSUB193715
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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) Yes
    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 Yes
    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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
    E.1.1.1Medical condition in easily understood language
    Short bowel length. With intestinal failure, the length and function of the small intestine falls below the minimum necessary for the absorption of nutrients and water to maintain good health.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10049416
    E.1.2Term Short-bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives:
    1) To assess safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks
    2) To assess the pharmacokinetic (PK) profile of HM15912
    E.2.2Secondary objectives of the trial
    To assess the pharmacodynamic (PD) profile of HM15912
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Men or women, aged 18 years of age or older with SBS resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is < 18 years).
    2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
    3. Diagnosis of SBS with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period
    4. Stable PN/IV, defined as less than 25% change in volume and energy within 4 weeks prior to screening.
    5. Willing to adhere to an individual 24-hour predefined drinking menu during 48-hours data collection periods
    6. (Only for the subjects who have a remnant part of colon) Have no colon polyps or had colon polyps removed by colonoscopy (or sigmoidoscopy) within 6 months prior to Screening
    7. Patients with jejunostomy or ileostomy and able to separate stool and urine during the 48-hour data collection period
    8. Have body weight ≥30 kg and body mass index (BMI) >18 kg/m²
    9. Have stable body weight during the last 6 months prior to Screening (±5% variations allowed)
    10. If the subject is not naïve to treatment with GLP-2 analog, the subject may be enrolled if all the following criteria are met:
    a. The duration of discontinuation of GLP-2 analog treatment should be at least 3 months prior to Screening
    b. Willing to provide medical history and/or record to recognize any medically significant events during previous GLP-2 analog treatment
    11. Sexually active female subjects of childbearing potential must use medically acceptable methods of birth control during the study and up to 60 days after the last dose of study drug (see Section 8.3.5 for a list of acceptable birth control methods).
    12. Sexually active male subjects must use medically acceptable
    methods of birth control during the study and up to 60 days after the last dose of study drug (see Section 8.3.5 for a list of acceptable birth control methods).
    E.4Principal exclusion criteria
    1. Any history of colon cancer.
    2. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years
    3. History of alcohol or drug abuse (within 1 year of Screening)
    4. Current participation in another study of an investigational agent or investigational device (catheter lock trials are allowed) within 4 weeks prior to the signing the ICF
    5. Have a body weight >100 kg
    6. Have clinically significant abnormal ECG findings (e.g., QTcF > 450 msec for males, QTcF> 470 msec for females, left bundle branch block) that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
    7. Have repeated (2 or more consecutive measurements separated by at least 15 minutes) systolic blood pressure (BP) measurements >140 mm Hg.
    8. Have a hospital admission within 1 month prior to Screening visit
    9. Females who are pregnant, breastfeeding, or expect to become pregnant within the projected duration of the study, starting with the Screening visit through 60 days after the final dose of study drug
    10. Males who plan to father children within the projected duration of the study, starting with the Screening visit through 60 days after the final dose of study drug
    11. Have any of the following conditions:
    a. Radiation enteritis,
    b. Scleroderma,
    c. Celiac disease (based on the review of medical history; subjects with normalized antibodies and histology can be considered for enrollment),
    d. Refractory/tropical sprue,
    e. Pseudo-obstruction,
    f. Cystic fibrosis,
    g. Pre-malignant/malignant change in colonoscopy biopsy or polypectomy,
    h. Surgery scheduled during the study period,
    i. Positive Human immunodeficiency virus (HIV) test,
    j. Active (chronic or acute) hepatitis B or C test,
    k. Positive syphilis test,
    l. Significant, active, uncontrolled, untreated systemic diseases
    12. Cannot maintain clinical remission of inflammatory bowel disease (IBD) prior to 3 months of Screening demonstrated by clinical assessment
    Note: Ulcerative Colitis (UC) Mayo Score < 2, Crohn's Disease (CD): Crohn's Disease Active Index (CDAI) <150
    13. Have more than 4 hospitalizations related to PN/IV volume adjustments within 12 months of Screenings
    14. Have cardiac disease defined as decompensated heart failure (New York Heart Association Class III- IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to Screening
    15. Have estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m² by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) 2021 or require hemodialysis.
    16. Clinically significant laboratory abnormalities at the time of Screening, defined as having:
    a. Platelet count < 100 × 10³/µL
    b. White blood cell count < 3.5 × 10³/µL
    c. Neutrophil count < 1.5 × 10³/µL
    d. Hemoglobin level < 8 g/dL
    17. Persistent hepatic impairment defined by two of the following laboratory tests meeting the criteria below. Repeat tests done within 2 weeks apart must confirm the results.
    a. Total bilirubin ≥ 2 × the upper limit of normal (ULN), or
    b. Aspartate aminotransferase (AST) ≥ 5 × ULN, or
    c. Alanine aminotransferase (ALT) ≥ 5× ULN
    18. Have any use of GLP-1, dipeptidyl peptidase 4 (DPP-4) inhibitor, growth hormone, glutamine, or analogs thereof within 3 months prior to Screening.
    19. Subject deemed by the Investigator to be inappropriate for participation in the study (e.g., any condition or circumstance which, in the Investigator's opinion, would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results).
    20. History of any serious adverse reaction or hypersensitivity to study drug components (polyethylene glycol or human IgG Fc fragment) or excipients (see Section 6.1 for detailed lists)
    E.5 End points
    E.5.1Primary end point(s)
    1) Primary endpoints to "assessment of safety and tolerability of HM15912 after multiple subcutaneous (SC) doses for 24 weeks:
    • Incidence of adverse events (AEs)
    • Incidence of injection site reactions
    • Incidence of clinical laboratory abnormalities
    • Clinically significant findings on physical examination
    • Changes from baseline in vital signs and 12-lead
    electrocardiogram (ECG) parameters

    2) Primary endpoints to "assessment of the pharmacokinetic (PK) profile of HM15912":
    • Maximum serum concentration (Cmax)
    • Time to maximum serum concentration (tmax)
    • Elimination half-life (t1/2)
    • Volume of distribution (Vd/F)
    • Clearance (CL/F)
    • Area under the concentration-time curve from time zero to the last
    observable concentration (AUClast), AUC from time zero over the
    dosing interval at the 1st and 6th dosing, respectively (AUCtau and
    AUCtau,ss), and AUC extrapolated to infinity (AUC0-∞)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout trial treatment/follow-up period.
    E.5.2Secondary end point(s)
    • Change in weekly parenteral nutrition/intravenous fluid (PN/IV) volume from baseline to Week 25
    Note: The baseline PN/IV volume (L/week) is the average of actual PN/IV volume received during the last 2 weeks of the Stabilization period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For time-point(s) see section E.5.2.
    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 Yes
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open label extension (only study drug)
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    United States
    Belgium
    Denmark
    France
    Germany
    Poland
    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
    A subject will be considered as having completed the study when:
    • Subject completes the Week 56 Visit
    OR
    • Subject completes the Follow-up Visit after End of Treatment
    Note: Subjects who are ADA positive any time between Week 41 and
    Week 53 will have an additional follow-up visit 4 months after the End
    of Treatment visit. In this case, End of Study is defined as subject
    completed the additional follow-up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days19
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 18
    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)
    The investigator is responsible for ensuring that consideration has been given to the post- trial care of the subject's medical condition.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medical Research Network (MRN)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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