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    Summary
    EudraCT Number:2007-005166-12
    Sponsor's Protocol Code Number:HMPL-004-US-02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-01-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-005166-12
    A.3Full title of the trial
    A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine
    A.4.1Sponsor's protocol code numberHMPL-004-US-02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHutchison MediPharma Enterprises Limited
    B.1.3.4CountryChina
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameHMPL-004
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHMPL-004
    D.3.9.3Other descriptive nameANDROGRAPHIS PANICULATA (ethanol extract)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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
    active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    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 of HMPL-004 given at 1200 mg/day, or 1800 mg/day in three divided doses, compared with placebo, in patients with mild to moderate ulcerative colitis as defined by the percent of patients in each treatment group attaining clinical response at week 8, which is a decrease in the Mayo Score from the baseline by ≥ 3 points AND ≥ 30% decrease in the Mayo score along with either a decrease in the rectal bleeding score ≥ 1 OR an absolute rectal bleeding score ≤ 1.
    E.2.2Secondary objectives of the trial
    • To determine if there is a significant difference in the proportion of patients in each treatment group with a clinical remission at week 8.
    • To determine if there is a significant difference in the proportion of patients in each treatment group with a significant decrease from baseline in the Mayo endoscopy sub score ≥ 1 AND absolute score ≤ 1 (mucosal healing).
    • To determine the time to response
    • To compare the decrease in the mean and median Mayo Score at baseline and week 8 in each treatment group.
    • To determine if there is a significant difference in any of the above efficacy measurements in patients with/without Mesalamine used as a concomitant medication.
    • To assess if there is a dose response difference in any of the above efficacy measurements in patients with two dose level of the HMPL-004.
    • To assess safety in patients

    Exploratory Objective:
    To determine normalization of the CRP values in those patients entering the study with elevated values.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Have active confirmed mild to moderate ulcerative colitis defined by a Mayo score 4-10, and with activity confirmed by study colonoscopy or sigmoidoscopy within 2 weeks prior to study entry.
    2) Minimum Mayo endoscopy score of ≥1 at the time of study colonoscopy or sigmoidoscopy.
    3) Age ≥ 18 years
    4) Have adequate renal, hepatic and bone marrow function (see exclusion criteria).
    5) Female patients must be of non-childbearing potential defined as meeting at least one of the following criteria:
    • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year*.
    • Premature ovarian failure confirmed by a specialist gynaecologist.
    • Previous bilateral salpingo-oophorectomy, or hysterectomy.
    • XY genotype, Turner’s syndrome, uterine agenesis.
    *Amenorrhoea following cancer therapy does not rule out childbearing potential.
    Fertile male and their partners must agree to use one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive which has been started at least one month prior to visit one, contraceptive patch, or condom with spermicide during the study participation and within 3 months thereafter.
    6) 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
    7) May be on Mesalamine (or equivalent medications sulfasalazine, balsalazide, olsalazine) if they have been on it for at least 4 weeks prior to randomization, and the dose has been stable for ≥ 2 weeks prior to randomization
    E.4Principal exclusion criteria
    1) 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 indeterminant colitis;
    2) Severe disease with an ulcerative colitis Mayo Clinical score above 10 points at baseline.
    3) Positive stool test for pathogens on any one of three samples taken within the previous 2 weeks prior to study entry.
    4) Toxic megacolon or toxic colitis
    5) Probable requirement for intestinal surgery within 12 weeks after the start of study medication
    6) Receiving oral or rectal steroids within 1 month prior to study entry.
    7) Receiving rectal Mesalamine within one week prior to study entry
    8) Receiving Azathioprine, 6 MP, or other immunosuppressive therapy including anti-TNF-α agents at the time of screening or within the preceding 6 weeks.
    9) Receiving other investigational drugs or biologics within 1 month.
    10) Receiving antibiotics within 2 week of study entry
    11) Hemoglobin concentration < 9 g/dl
    12) WBC below 3,000/cmm, or platelets below 100,000/cmm
    13) SGOT, SGPT, alkaline phosphatase >2.5 upper limit of normal
    14) Serum creatinine >1.5 times upper limit of normal
    15) 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.
    16) Chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative) or any history of Hepatitis C.
    17) Previous colonic surgery except for simple polypectomy.
    18) History of cancer within the last 5 years other than resected cutaneous basal and squamous cell carcinomas, in situ cervical cancer and surgically removed colon polyps.
    19) Women who are pregnant or breast feeding ;
    20) Patients known to be seropositive for HIV, or who have had an AIDS defining illness, or a known immunodeficiency disorder
    21) Patients with a history of tuberculosis or exposure to tuberculosis, or a history of a chest X ray suspicious for tuberculosis, unless shown to be PPD negative.
    22) History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure;
    23) Known allergy to plants of the Acanthaceae family;
    24) Unwillingness to participate in the study;
    25) 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)
    Percentage of patients in each treatment group with a decrease in Mayo Score from baseline ≥ 3 AND ≥ 30% decrease in the Mayo score, along with either a decrease in rectal bleeding score ≥ 1 OR absolute rectal bleeding score ≤ 1 after 8 weeks of treatment with HMPL-004 given orally three times/day.
    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 No
    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 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.8.3 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 EEA15
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    N/A
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 210
    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)
    Any Grade 3 or 4 adverse event or serious adverse event is followed up until it has resolved or stabilized. Otherwise, patients will receive normal treatment.
    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 Decision2008-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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