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    Summary
    EudraCT Number:2015-001022-42
    Sponsor's Protocol Code Number:IBD98-M-2002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-29
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-001022-42
    A.3Full title of the trial
    A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis
    Studio multicentrico di fase 2a, randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, di IBD98-M in capsule a rilascio ritardato per indurre la remissione in pazienti affetti da colite ulcerosa attiva da lieve a moderata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis
    A.4.1Sponsor's protocol code numberIBD98-M-2002
    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 SponsorHoly Stone Healthcare Co., Ltd.
    B.1.3.4CountryTaiwan
    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 supportHoly Stone Healthcare Co., Ltd.
    B.4.2CountryTaiwan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHoly Stone Biotech Co., Ltd.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressCedar House, 105 Carrow Road
    B.5.3.2Town/ cityNorwich, Norfolk
    B.5.3.3Post codeNR1 1HP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+41 22 704 0545
    B.5.5Fax number+41 22 704 0549
    B.5.6E-mailinfo@hsbiotech.co.uk
    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 nameIBD98-M Delayed-release Capsules
    D.3.2Product code IBD98-M
    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 INNSODIUM HYALURONATE
    D.3.9.1CAS number 9067-32-7
    D.3.9.3Other descriptive nameSODIUM HYALURONATE
    D.3.9.4EV Substance CodeSUB12289MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number23
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMESALAZINE
    D.3.9.1CAS number 89-57-6
    D.3.9.3Other descriptive nameMesalamine, 5-ASA
    D.3.9.4EV Substance CodeSUB08782MIG
    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 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
    Active, Mild to Moderate Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 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
    To compare the percentage of patients in UC remission at Week 6 for each of the 2 IBD98-M dose groups versus placebo (remission defined as the modified Ulcerative Colitis Disease Activity Index [UCDAI] score of ≤1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1)
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    ● To compare clinical improvement rates at Week 6 among treatment groups (defined as a ≥3 point reduction from baseline in the modified UCDAI score)
    ●To compare endoscopic improvement at Week 6 among treatment groups (defined as a ≥1 point decrease in modified UCDAI mucosal appearance subscore)
    ● To determine the change in symptoms (rectal bleeding and stool frequency) from baseline to each study visit among treatment groups
    ● To evaluate the safety and tolerability profile of IBD98-M
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age ≥18 and <75 years, suffering from UC for at least 6 months prior to screening.
    2. If the patient is a female, she is eligible to enter the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses).
    OR
    If she is of childbearing potential, she is eligible to enter the study if she has a negative serum pregnancy test at screening and, one of the following:
    a) Agrees to use hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, implants, intrauterine hormone-releasing system (IUS), intrauterine device (IUD) inserted by a qualified clinician with published data showing that the lowest expected failure rate is less than or equal to 1% per year (not all IUDs meet this criterion), for the duration of the study, plus a further 90-day period. The Investigator will be responsible for determining whether the patient is using appropriate birth control method for study participation.
    b) Has a vasectomized partner (provided that partner is the sole sexual partner and that the vasectomized partner has received medical assessment of the surgical success), or the partner agrees to use medically acceptable and highly effective method of contraception such as double barrier method of contraception, specifically, use of a condom and spermicide throughout the study period and 90-day period after the study.
    c) For non-sexually active females, abstinence may be regarded as an adequate method of birth control only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. However, if the patient becomes heterosexually active during the study treatment period, she must agree to use adequate birth control methods as defined above for the remainder of the study treatment period.
    3. If the patient is a male, he is eligible to enter the study if he is vasectomized or agrees to use medically acceptable and highly effective method of contraception such as double barrier method of contraception, specifically, use of condom and spermicide throughout the study period and 90-day period after the study.
    4. Diagnosis of active UC with modified UCDAI ≥4 and ≤10, with endoscopy score of ≥1 in the modified UCDAI mucosal appearance subscore.
    5. Patients with either newly diagnosed or relapsed UC (onset of current episode of relapse must be within 6 weeks prior to screening). In addition, the diagnosis of UC must be confirmed by endoscopic and histologic evidence in the past; if prior confirmation is not available, this must be done at the time of screening visit.
    6. Patients must have up-to-date surveillance colonoscopy for malignancy, per treatment guideline.
    7. Willing and able to provide signed informed consent
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria are ineligible to participate in this study:
    1. Patients diagnosed with Crohn’s disease, indeterminate colitis, ischaemic colitis, or active gastric or active duodenal ulcers.
    2. Female patients who are pregnant or breastfeeding
    3. Ulcerative proctitis with ≤15 cm of disease
    4. Patients with infectious colitis, as determined by assessment for Clostridium difficile (C. difficile) and fecal pathogens at screening, or treatment for C. difficile within 30 days prior to screening
    5. History of or current evidence of toxic megacolon, fulminant colitis (e.g., Lichtiger score of ≥10), colonic perforation
    6. Any previous colonic surgery (except appendectomy) or short bowel syndrome
    7. Patients who required doses of mesalamine higher than 2.4 g/day for maintenance.
    8. Hypersensitivity to salicylates/aspirin
    9. Use of the following medications:
    a - Use of oral or rectal 5 aminosalicylic (5-ASA) within 11 days prior to randomization.
    b - Use of systemic or rectal corticosteroid within 4 weeks prior to or during screening.
    c - Use of anti-tumor necrosis factor-alpha (anti TNF-α) agents or other biologics such as vedolizumab within 90 days prior to or during screening.
    d - Use of immunosuppressants (e.g., azathioprine, mercaptopurine) within 6 weeks prior to or during screening.
    e - Use of antibiotics for UC within 7 days prior to or during screening.
    10. Clinically significantly abnormal ECG at screening
    11. Liver cirrhosis or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels >2 times the upper limit of normal (ULN)
    12. Serum creatinine >2X ULN
    13. Known history of drug or alcohol abuse within the last 3 years prior to screening
    14. Participation in another clinical trial involving an investigational agent within 3 months prior to screening (Visit 1). Patients cannot participate in any other investigational medication or medical device trial while participating in this study (participation in a registry or observational study without an additional therapeutic intervention is allowed)
    15. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator, would confound the study results or compromise patient safety
    16. Had any surgical procedure requiring general anesthesia within 30 days prior to screening or is planning to undergo major surgery during the study period
    17. Any active malignancy within the last 5 years, except for basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised
    18. Patient has a history of hepatitis B or C (HVB or HVC) or human immunodeficiency virus (HIV). HVB-HVC positive is defined as positive hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb; also referred to as anti-HBc), and/or hepatitis C antibody (HCVAb) with confirmation by hepatitis C virus ribonucleic acid (HCV RNA). For HIV, patient’s verbal confirmation that he/she is HIV negative is acceptable.
    19. In the opinion of the Investigator, the patient is unable to adhere to the requirements of the study

    E.5 End points
    E.5.1Primary end point(s)
    ● Percentage of patients in remission at Week 6
    Remission as defined by modified UCDAI score of ≤1, with a score of 0 for rectal bleeding and stool frequency, no mucosal friability, and sigmoidoscopy score not exceeding 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are as follows:
    • Proportion of patients with clinical improvement at Week 6 (defined as a ≥3 point reduction from baseline in the modified UCDAI score)
    • Proportion of patients with endoscopic improvement at Week 6 (defined as a ≥1 point decrease in modified UCDAI mucosal appearance subscore)
    • Change in symptoms (rectal bleeding and stool frequency) from baseline to each study visit
    The safety endpoints are as follows:
    • Incidence and severity of all TEAEs
    • Incidence and severity of SAEs
    • Systemic tolerance (physical examination, vital signs, electrocardiograms [ECGs], and laboratory assessments of safety parameters)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints for secondary efficacy endpoints are as follows:

    • Proportion of patients with clinical improvement at Week 6 (defined as a ≥3 point reduction from baseline in the modified UCDAI score)
    • Proportion of patients with endoscopic improvement at Week 6 (defined as a ≥1 point decrease in modified UCDAI mucosal appearance subscore)
    • Change in symptoms (rectal bleeding and stool frequency) from baseline to each study visit
    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 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) 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 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 concerned11
    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
    LSLV
    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 months8
    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 months8
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state51
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 51
    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)
    standard of care
    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 Decision2015-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
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