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    Summary
    EudraCT Number:2017-000937-30
    Sponsor's Protocol Code Number:ABX464-101
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-000937-30
    A.3Full title of the trial
    A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids.
    Eine Phase-IIa-Studie zur Bewertung der Sicherheit und Wirksamkeit von einmal täglich 50 mg ABX464 im Vergelich zu Placebo bei Patienten mit mäßiger bis schwerer aktiver Colitis ulcerosa, bei denen entweder die Immunmodulatoren, Anti-TNFα, Vedolizumab und / oder Kortikosteroid Therapie versagt hat, oder die sie gegen die Wirkstoffe intolerant sind.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.
    A.3.2Name or abbreviated title of the trial where available
    Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.
    Sicherheits- und Wirksamkeitsstudie von ABX464 bei Patienten mit mäßiger bis schwerer aktiver Coliti
    A.4.1Sponsor's protocol code numberABX464-101
    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 SponsorABIVAX
    B.1.3.4CountryFrance
    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 supportAbivax
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbivax
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address5 Rue dela Baume
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 153830961
    B.5.6E-mailpaul.gineste@abivax.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 ABX464
    D.3.4Pharmaceutical form Capsule, hard
    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 INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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, hard
    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
    Moderate to severe Ulcerative Colitis.
    Colite ulcéreuse modérée à sévère.
    E.1.1.1Medical condition in easily understood language
    In Ulcerative Colitis the lining of the colon becomes inflamed and develops tiny open sores that produce pus and mucous.This causes abdominal discomfort and frequent emptying of the colon (diarrhoea).
    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 10066678
    E.1.2Term Acute 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 the study is to evaluate safety of ABX464 given at 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of ABX464 :
    -on the expression of IL-22 in serum and rectal/sigmoidal tissue compared to placebo in subjects with Moderate to Severe Active Ulcerative Colitis.
    -on miR-124 expression in whole blood (PAXgene®) and in tissue (RNA later) vs placebo in subjects with Moderate to Severe Active Ulcerative Colitis.
    -on the rectal/sigmoidal infiltrates (Geboes score) vs placebo in subjects with Moderate to Severe Active Ulcerative Colitis.
    -on the rectal microbiome compared to placebo in subjects with Moderate to Severe Active Ulcerative Colitis
    -on endoscopic remission vs placebo in subjects with Moderate to Severe Active Ulcerative Colitis.
    -on clinical remission and response vs placebo in subjects with Moderate to Severe Active Ulcerative Colitis.
    -on Quality of Life (QoL) measured by the SF-36 questionnaire vs placebo in subjects with Moderate to Severe Active Ulcerative Colitis.
    - to assess pharmacokinetic parameters in subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Men or women age 18 - 75 years;

    - Diagnosis of moderate to severe active UC confirmed by endoscopy and histology at least 12 weeks prior to screening visit. Moderate to severe active UC defined by Mayo Clinic Score (MCS) of 6 to 12 inclusive (on a scale of 0-12). Moderate to severe active UC should be confirmed at screening visit with a centrally read MCS endoscopy score of at least 2 (on a scale of 0-3);

    -Subjects receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent ≤20 mg/day) or on beclomethasone diproprionate (≤5mg/day) or on budesonide MMX (≤9mg/day), for ≥2 weeks before the screening visit;

    -Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn ≥2 weeks before the screening visit due to inefficacy or intolerance.
    -Subjects who are on oral 5-aminosalicylic acid must have been on a stable dose ≥4 weeks before the screening visit;

    -Subjects who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for 4 weeks before the screening visit. Subjects taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication;

    -Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii) must be on stable doses for 2 weeks before the screening visit;

    -Subjects on antidiarrheals (e.g., loperamide, diphenoxylate with atropine) must be on stable doses for 2 weeks before the screening visit;

    -Subjects who have previously received anti-tumor necrosis factor (TNF) therapy or vedolizumab must have discontinued therapy ≥8 weeks before the screening visit due to inefficacy or intolerance.

    -Subjects previously treated with cyclosporine or tacrolimus must have discontinued therapy ≥4 weeks before the screening visit due to inefficacy or intolerance.

    -Subjects previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 weeks before the screening visit;

    -Subjects with hematological and biochemical laboratory parameters as follows and within 14 days of baseline:
    o Hemoglobin > 9.0 g dL-1;
    o Absolute neutrophil count ≥ 750 mm-3;
    o Platelets ≥ 100,000 mm-3;
    o Total serum creatinine ≤ 1.3 x ULN (upper limit of normal);
    o Creatinine clearance > 50 mL min-1 by the
    Cockcroft-Gault equation within 60 days of entry;
    o Total serum bilirubin < 1.5 x ULN;
    o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 1.5 x
    ULN;

    -Subjects should be able and willing to comply with study visits and procedures as per protocol;

    -Subjects should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;

    -Subjects should be affiliated to a social security regimen (for French sites only);

    -Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 2 weeks prior to study participation. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception associated with inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the subject. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle.
    E.4Principal exclusion criteria
    -Subject with Crohn's Disease (CD), indeterminate colitis (IC) or presence or history of fistula with CD;

    -History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or is at imminent risk of colectomy;

    -History or current evidence of colonic dysplasia or adenomatous colonic polyps. Subject with severe gastrointestinal complications; e.g., short bowel syndromes, obstructing strictures, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation;
    -Subject with significant and known active infections at screening such as Infected abscess, positive for Clostridium difficile (stool antigen and toxin), CMV, TB and recent infectious hospitalization;

    - Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;

    -Acute, chronic or history of immunodeficiency or autoimmune disease;

    - History of malignancy unless there has been surgical excision that is considered to have achieved cure;

    - Active malignancy that may require chemotherapy or radiation therapy;

    - Seizure disorder or any history of prior seizure;

    - Serious illness requiring systemic treatment and/or hospitalization within 3 weeks prior to baseline;

    - Pregnant or breast-feeding woman;

    - Active drug or alcohol abuse or dependence;

    - Use of any investigational or non-registered product within 3 months preceding baseline;

    - Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Number of incidences of treatment-emergent adverse events in the ABX464 treated subjects compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of this end point from day 0 to EoS.
    E.5.2Secondary end point(s)
    Primary Efficacy endpoint:
    1.The proportion of subjects receiving ABX464 with clinical remission
    according to the Total Mayo Score at week 8 compared to placebo.
    Remission exclude friability and is based on total Mayo score ≤ 2 with no individual sub-score > 1.

    Other secondary end points :
    2.The change from screening in IL-22 expression levels in serum and rectal/sigmoidal tissue at week 8 compared to placebo.
    3.The change from baseline in microRNA-124 levels in whole blood (PAXgene®) and in tissue (RNA later) at week 4 and week 8 compared to placebo.
    4.The change from baseline in fecal calprotectin levels at week 4 and week 8 compared to placebo.
    5.The change from screening in the histopathology/infiltrate (rectal/sigmoidal biopsies) assessed by the Geboes score at week 8 compared to placebo.
    6.The change from screening in rectal microbiota using taxonomic markers at week 8 compared to placebo
    7.The change from screening in Total Mayo Score in subjects receiving ABX464 at week 8 compared to placebo.
    8.The change from baseline in Partial Mayo Score in subjects receiving ABX464 at week 4 and week 8 compared to placebo.
    9.The proportion of subjects achieving endoscopic remission at week 8. Endoscopic remission is defined as a Mayo endoscopic sub-score of 0.
    10.The proportion of subjects achieving improvement in endoscopic appearance at week 8. Improvement of endoscopic appearance is defined as a Mayo endoscopic sub-score of ≤ 1.
    11.The proportion of subjects achieving a symptomatic remission at week 8. Symptomatic remission is defined as a total Mayo Score ≤ 2 with no individual sub-score > 1 and rectal bleeding and stool frequency sub-scores of 0.
    12.The time to UC worsening after week 8.
    13.The serum concentration evaluation of ABX464 and its metabolites levels.
    14.The scores and changes from baseline in SF-36 Questionnaire scores at week 4 and week 8.
    15.The number of incidences of treatment-emergent serious adverse events.
    16.The number of incidences of treatment-emergent adverse events of special interest.
    17.The number of incidences of adverse events leading to investigational product discontinuation.
    18.The number of incidences of specific laboratory abnormalities.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At week 8 compared to placebo.
    2. At week 4 and week 8 compared to placebo.
    3. At week 4 and week 8 compared to placebo.
    4. At week 8 compared to placebo.
    5. At week 8 compared to placebo.
    6. At week 8 compared to placebo.
    7.At week 4 and week 8 compared to placebo.
    8.At week 8 compared to placebo.
    9.At week 8.
    10. At week 8.
    11. At week 8.
    12. After week 8.
    13. As per metabolite levels.
    14. At week 4 and week 8.
    15. Throughout the study.
    16. Throughout the study.
    17. Throughout the study.
    18. Throughout the study.
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days77
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days77
    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: 28
    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 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)
    Normal 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 Decision2017-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-25
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