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    Summary
    EudraCT Number:2013-002116-27
    Sponsor's Protocol Code Number:HMPL-004-03
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-06-26
    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 ConcernedLatvia - SAM
    A.2EudraCT number2013-002116-27
    A.3Full title of the trial
    A Phase III, Randomized, Multi-Centre, Double-Blind,
    Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis
    A.4.1Sponsor's protocol code numberHMPL-004-03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01805791
    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 SponsorNutrition Science Partners Limited
    B.1.3.4CountryHong Kong
    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 supportNutrition Science Partners Limited
    B.4.2CountryHong Kong
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNutrition Science Partners Limited
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street Address22nd Floor, Hutchison House, 10 Harcourt Road,
    B.5.3.2Town/ cityHong Kong
    B.5.3.4CountryHong Kong
    B.5.6E-mail004Team@hmplglobal.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.3.2Product code HMPL-004
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 8000051-24-3
    D.3.9.2Current sponsor codeHMPL-004
    D.3.9.3Other descriptive nameANDROGRAPHIS PANICULATA
    D.3.9.4EV Substance CodeSUB12898MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 5508-58-7
    D.3.9.3Other descriptive nameAND (Andrographolide)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 27215-14-1
    D.3.9.3Other descriptive nameNAND (Neoandrographolide)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 4176-97-0
    D.3.9.3Other descriptive nameDAND (14-Deoxyandrographolide)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 42895-58-9
    D.3.9.3Other descriptive nameDDAND (14-deoxy-11,12-didehydroandrographolide)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 327-97-9
    D.3.9.3Other descriptive nameCLA (Chlorogenic acid)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 29741-09-1
    D.3.9.3Other descriptive nameAODG (Apigenin-7-O-glucuronide)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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 placeboTablet
    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
    Ulcerative Colitis (UC)
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis (UC) is a disease where inflammation develops in the large intestine (the colon and rectum).
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy as defined by the percentage of patients attaining clinical remission following 8 weeks of induction treatment of HMPL-004 given at a dosing level of either 1800 mg/day or 2400 mg/day as compared with placebo in patients with mild to moderate ulcerative colitis that currently have a sub-optimal response to their current regimen of mesalamine.
    E.2.2Secondary objectives of the trial
    Secondary endpoints of this study include clinical response and mucosal healing. In this study, each of the colon segments (cecum/ascending, transverse, descending, sigmoid, and rectum) will be reviewed endoscopically and centrally evaluated at the beginning of the study (screening phase) and at end of study to observe the extent of colonic involvement before and after treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients must be currently receiving mesalamine ≥ 2.4 g/day (or the equivalent) for at least 6 weeks prior to randomization and on a stable dosage for at least 2 weeks prior to entering the screening phase of the study to ensure a stable dose is established at least 2 weeks prior to the
    endoscopic procedures.
    2) Have active mild to moderate ulcerative colitis defined by a modified Mayo Score 4-10, and with endoscopy score activity of 2-3 points confirmed by a full colonoscopy within 2 weeks prior to randomization. Activity can be in any of the 5 colon segments.
    3) Age ≥ 18 years.
    4) Patients have no prior exposure to HMPL-004.
    5) Have adequate renal, hepatic and bone marrow function (see exclusion criteria).
    6) All fertile male and female subjects must agree to use one of the following types of contraception: intrauterine device, implantable progesterone device, and progesterone intramuscular injection, oral contraceptive which has been started at least one month prior to visit one and continues for the duration of the trial, contraceptive patch, or condom with spermicide.
    7) Show evidence of a personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial
    E.4Principal exclusion criteria
    1) Subjects with intolerance or adverse reactions to mesalamine (or equivalent medications).
    2) Diagnosed with Crohn’s disease or with lesions such as fistulas or granulomas on biopsy noted either in history or at baseline endoscope, which would be suspicious for Crohn’s disease, or with a diagnosis of indeterminate colitis.
    3) Severe disease with an ulcerative colitis modified Mayo Clinic score above 10 points at baseline.
    4) Positive stool test for pathogens for sample taken within the previous 2 weeks prior to study entry.
    5) Active Clostridium difficile (C. diff) infection.
    6) Use of IBD related herbal supplements including supplements containing andrographis and probiotics two weeks prior to study entry or during the study.
    7) Toxic megacolon or toxic colitis.
    8) Probable requirement for intestinal surgery within 12 weeks after the start of study medication.
    9) Receiving oral or rectal steroids within 1 month prior to study entry.
    10) Receiving rectal mesalamine within one week prior to study entry.
    11) Receiving azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, or other immunosuppressive therapy at the time of screening or within the preceding 6 weeks.
    12) Receiving anti-TNF-α agents such as infliximab, adalimumab, golimumab, or certolizumab pegol at the time of screening or within the preceding 8 weeks.
    13) Receiving other investigational drugs or biologics within 1 month or five half lives.
    14) Receiving antibiotics within 2 weeks of study entry.
    15) Hemoglobin concentration < 9 g/dl.
    16) WBC below 3,000/ cm3, or platelets below 100,000/ cm3.
    17) SGOT, SGPT, alkaline phosphatase >2.5 upper limit of normal.
    18) Serum creatinine >1.5 times upper limit of normal.
    19) Significant concurrent medical diseases including: active peptic ulcer disease; uncompensated congestive heart disease; myocardial infarction within the last 12 months; unstable angina pectoris; uncontrolled hypertension; pulmonary disease requiring oxygen therapy.
    20) Chronic Hepatitis B any history of Hepatitis C.
    21) Previous colonic surgery except for simple polypectomy.
    22) History of cancer within the last 5 years other than resected cutaneous basal and squamous cell carcinomas, and in situ cervical cancer.
    23) Patients with a history of or concurrent colonic dysplasia associated with UC, except those with completely excised sporadic colorectal polyps.
    24) Women who are pregnant or breast feeding.
    25) Patients known to be seropositive for HIV, or who have had an AIDS defining illness, or a known immunodeficiency disorder.
    26) History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
    27) Known allergy to plants of the Acanthaceae family.
    28) Unwillingness to participate in the study.
    29) Any underlying medical condition that in the Investigator’s opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission will be measured by the modified Mayo Score (also known as the Clinical Mayo Score or the disease activity index [DAI]), which serves as the current leading measurement of disease and is used in many of the ulcerative colitis trials.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    1) The proportion of patients with clinical response at Week 8 in each HMPL-004 group compared with the placebo group.
    2)The proportion of patients with mucosal healing at Week 8 in each HMPL-004 group compared with the placebo group.
    3) To determine the time to response as measured by the first assessment at which there was a significant difference between the proportion of patients in either treatment group and placebo who showed a decrease in the partial Mayo Score of ≥ 2 as compared to baseline at Weeks 2, 4, 6 and 8.
    4) Decrease in the mean and median modified Mayo Score at baseline and Week 8 in each treatment group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 8
    2) Week 8
    3) Weeks 2, 4, 6, 8
    4) Week 8
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 trial3
    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 EEA38
    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
    Bulgaria
    Czech Republic
    Hungary
    Korea, Republic of
    Latvia
    Lithuania
    Poland
    Ukraine
    United States
    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 visit of the Last Subject (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 months6
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 187
    F.4.2.2In the whole clinical trial 420
    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 Decision2013-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-08-13
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