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    Summary
    EudraCT Number:2020-002833-13
    Sponsor's Protocol Code Number:AMT-101-203
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-19
    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 number2020-002833-13
    A.3Full title of the trial
    A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of AMT-101 in combination with Adalimumab in patients with Ulcerative Colitis.
    A.4.1Sponsor's protocol code numberAMT-101-203
    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 SponsorApplied Molecular Transport Inc.
    B.1.3.4CountryUnited States
    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 supportApplied Molecular Transport Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApplied Molecular Transport Inc.
    B.5.2Functional name of contact pointClinical Trial AMT-101-202
    B.5.3 Address:
    B.5.3.1Street Address450 East Jamie Court
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number1650392 0420
    B.5.6E-mailCT101@appliedmt.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.3.1Product nameAMT-101
    D.3.4Pharmaceutical form Gastro-resistant 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.3.8INN - Proposed INNNot yet assigned
    D.3.9.3Other descriptive nameAMT-101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeADALIMUMAB
    D.3.9.3Other descriptive nameHUMIRA
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 placeboGastro-resistant tablet
    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
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation and ulcers in the colon resulting in abdominal pain and bloody diarrhea
    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 evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity as measured by symptoms, endoscopy, histology, and biomarkers
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    - To evaluate the safety and tolerability of AMT-101 over 8 weeks
    - To assess the pharmacokinetic (PK) parameters of AMT-101 in combination with adalimumab
    - To assess health-related quality of life (HRQOL)
    - To assess the pharmacodynamic (PD) effect of AMT-101 on biomarkers
    - To assess target engagement and mechanism of action


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study will enroll male and female adult subjects with moderate to severe UC.
    Inclusion criteria (subjects must meet the following criteria to be randomized into the study):
    1. Male and female subjects aged 18 to 75 years, inclusive.
    2. Diagnosis of UC for at least 3 months prior to screening.
    3. Moderate to severe UC, as defined by a total MCS of 6 to 12 inclusive at baseline, with a MES ≥ 2 (confirmed by central reader).
    4. Eligible for adalimumab therapy.
    5. Naïve to therapy with approved or investigational biologics/tofacitinib including any anti-tumor necrosis factor (TNF) therapy, vedolizumab, or ustekinumab.
    6. If subjects are receiving the following treatments, they must be on a stable dose for at least 4 weeks prior to randomization:
    a. 5-aminosalicylates (5-ASAs) (not exceeding 4.8 g per day).
    b. Oral corticosteroids (not exceeding prednisone 20 mg, budesonide 9 mg, or equivalent).
    c. 6-mercaptopurine (6-MP) (any stable dose).
    d. Azathioprine (AZA) (any stable dose).
    e. Methotrexate (MTX) (any stable dose).
    Note: subjects may be using 5-ASA and only 1 of the other medications listed (oral corticosteroids/6 MP/AZA/MTX).
    7. If subjects are receiving bile-salt sequestrant, they must be on a stable dose for at least 3 months prior to randomization.
    8. If subjects are receiving any nonprohibited medications, they must agree to maintain stable doses of concomitant medications for UC until the end of the safety follow-up period.
    9. Unlikely to conceive.
    10. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit prior to the first dose of study drug.
    11. Able to participate fully in all aspects of this clinical trial.
    12. Written informed consent must be obtained and documented.
    E.4Principal exclusion criteria
    Exclusion criteria (subjects who exhibit any of the following criteria are to be excluded from the study):
    1. A diagnosis of Crohn’s disease (CD), indeterminate colitis, or presence or history of fistula with CD.
    2. Disease activity limited to distal 15 cm (proctitis).
    3. Current evidence of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma.
    4. History or current evidence of colonic dysplasia or adenomatous colonic polyps.
    5. Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile;; known active cytomegalovirus infection; known infection with hepatitisB or C virus; known infection with human immunodeficiency virus; infection requiring hospitalization or intravenous (IV) antimicrobial therapy, or opportunistic infection within 6 months prior to screening; any infection requiring antimicrobial therapy within 2 weeks prior to screening; history of more than 1 episode of herpes zoster or any episode of disseminated zoster.
    6. A positive diagnostic tuberculosis (TB) test at screening (defined as a positive QuantiFERON test). In cases where the QuantiFERON test is indeterminate, the participant may have the test repeated once and if their second test is negative, they will be eligible. In the event a second test is also indeterminate, or QuantiFERON is unavailable, the investigator has the option to perform a purified protein derivative (PPD) skin test. If the PPD reaction is < 5 mm, then the subject is eligible. If the reaction is ≥ 5 mm, or PPD testing is not done, the subject is not eligible. An exception is made for subjects with a history of latent TB who are currently receiving treatment for latent TB, will initiate treatment for latent TB before the first dose of study treatment, or have documentation of completing appropriate treatment for latent TB within 3 years prior to the first dose of study treatment.
    7. Live virus vaccination within 1 month prior to screening.
    8. Any prior treatment with an approved or investigational biologic/tofacitinib, including anti-TNF therapy, vedolizumab, or ustekinumab.
    9. Treatment with sirolimus, cyclosporine, mycophenolate, or tacrolimus within 8 weeks prior to randomization.
    10. Treatment with IV corticosteroids, rectal corticosteroids, or rectal 5-ASA within 4 weeks prior to randomization.
    11. Fecal microbiota transplantation within 1 month prior to screening.
    12. A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject’s ability to participate fully in the study.
    13. A diagnosis of multiple sclerosis or optic neuritis, or history of a demyelinating disorder.
    14. Known primary or secondary immunodeficiency.
    15. History of myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (New York Heart Association Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening.
    16. Clinically meaningful laboratory abnormalities at screening that would affect subject safety, as determined and documented by the investigator.
    17. Pregnant or lactating females.
    18. Any surgical procedure requiring general anesthesia within 1 month prior to screening, or planned elective surgery during the study.
    19. History of malignant neoplasms or carcinoma in situ within 5 years prior to screening.
    20. Current or recent history of alcohol dependence or illicit drug use that, in the opinion of the investigator, may interfere with the subject’s ability to comply with the study procedures.
    21. Mental or legal incapacitation or a history of clinically significant psychiatric disorders at the time of the screening visit that would impact the ability to participate in the trial according to the investigator.
    22. Unable to attend study visits or comply with procedures.
    23. Concurrent participation in any other interventional study or received any investigational therapy within 1 month of randomization.
    24. Previous exposure to AMT-101 or recombinant human interleukin-10 (rhIL-10).
    25. A known hypersensitivity to AMT-101, adalimumab, or their respective excipients.
    26. Current treatment with antimotility medications or antidiarrheals (except for bile-salt sequestrants).

    E.5 End points
    E.5.1Primary end point(s)
    Mean change in UC-100 score from baseline


    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    - Mean change in Robarts Histopathology Index (RHI) from baseline
    - Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline
    - Mean change in fecal calprotectin from baseline
    - Mean change in high-sensitivity C-reactive protein (hs CRP) from baseline
    - Endoscopic remission rate (defined as a MES of 0 or 1)
    - Endoscopic response rate (defined as a decrease from baseline in MES of at least 1 point)
    - Mucosal healing rate (defined as MES of 0 or 1 and a Geboes Histologic Index score of ≤ 3.1)
    - Histologic remission rate (defined as Geboes Histologic Index score of ≤ 2B.0; or Robarts Histopathology Index [RHI] ≤ 3 with subscores of 0 for lamina propria neutrophils and 0 for neutrophils in epithelium)
    - Proportion of subjects who achieve a 50% reduction in RHI
    - Clinical remission rate (defined as total MCS ≤ 2 with all subscores ≤ 1)
    - Clinical response rate (defined as decrease from baseline in MCS of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1)
    - Clinical remission rate (alternative definition of Mayo stool frequency subscore of 0 or 1 and Mayo rectal bleeding subscore of 0 and MES of 0 or 1)

    Secondary Safety Endpoints:
    - Frequency and severity of adverse events (AEs)
    - Changes in clinical chemistry and hematology from baseline
    - Changes in vital signs and physical examinations from baseline
    - Electrocardiogram (ECG) findings

    Secondary Exploratory Endpoints:
    - Concentrations of AMT-101, AMT-101 antidrug antibodies (ADAs), total interleukin-10 (IL-10), adalimumab, and adalimumab ADAs in serum
    - Concentrations of AMT-101, AMT-101 ADAs, and total IL-10 in mucosal tissue biopsies
    - Mean change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline
    - Change in white blood cell count
    - Change in fecal matrix metalloproteinase 9 (MMP-9)
    - Change in fecal lactoferrin
    - Change in interleukin-1 receptor antagonist (IL-1Ra)
    - Change in serum and mucosal tissue protein levels
    - Change in mucosal tissue gene expression
    - Change in mucosal tissue cell populations
    - Change in fecal microbiome

    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4, and 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 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 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 concerned8
    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
    Georgia
    Netherlands
    Poland
    Ukraine
    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
    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 months3
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days29
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 24
    F.4.2.2In the whole clinical trial 50
    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)
    Once clinical trial participants have completed the 4 week follow-up visit, the participants will no longer receive study drug. The study doctor will talk to them about how best to continue their medical 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 Decision2021-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-13
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