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    EudraCT Number:2019-000824-17
    Sponsor's Protocol Code Number:BT-11-202
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-10-21
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedCroatia - MIZ
    A.2EudraCT number2019-000824-17
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease.
    A.4.1Sponsor's protocol code numberBT-11-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03870334
    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 SponsorLandos Biopharma 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 supportLandos Biopharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation Landos Biopharma Inc.
    B.5.2Functional name of contact pointJyoti Chauhan
    B.5.3 Address:
    B.5.3.1Street Address1800 Kraft Drive, Suite 216
    B.5.3.2Town/ cityBlacksburg VA
    B.5.3.3Post code24060
    B.5.3.4CountryUnited States
    B.5.4Telephone number+15402181767
    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 BT-11
    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.3.8INN - Proposed INNBT-11
    D.3.9.1CAS number 1912399-91-7
    D.3.9.3Other descriptive nameBT-11
    D.3.9.4EV Substance CodeSUB197889
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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
    Patients with Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Inflammatory Bowel Disease
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the proof-of-concept efficacy and safety of oral BT-11 in inducing clinical remission and endoscopic response at Week 12 in subjects with moderately to severely active Crohn’s disease (CD).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the following at Week 12:
    1. The effects of BT-11 on disease activity as measured by symptoms, colonoscopy, histology, and biomarkers
    2. Health-related quality of life
    3. The pharmacokinetic (PK) parameters of BT-11

    Exploratory Objectives
    The exploratory objectives of this study are to evaluate the following through Week 30:
    1. The effects of BT-11 on disease activity measured by symptoms, colonoscopy, histology, and biomarkers
    2. Health-related quality of life
    3. The PK parameters of BT-11
    4. Target engagement and mechanism of action
    5. The association of drug exposure in colonic mucosal tissue biopsies with clinical, endoscopic, histopathologic, and molecular outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects aged 18 to 75 years, inclusive.
    2. Diagnosis of CD for at least 3 months prior to screening.
    3. Moderately to severely active CD as defined by all of the following:
    a) CDAI score of 220-450.
    b) SES-CD ≥ 6 (≥ 4 for isolated ileitis) scored by a blinded central reader.
    4. If subjects have previously received biologic therapy for CD (i.e., TNF-antagonists, vedolizumab, natalizumab, or ustekinumab), they must have a washout period of 8 weeks prior to randomization (or within 4 weeks prior to randomization, if no detectable drug levels confirmed by validated or commercial assay), and any previous failure (i.e., primary or secondary nonresponse) to biologic treatment is limited to only 1 class of biologic; prior exposure to biologics that have been discontinued for reasons other than nonresponse will not be limited. (Note: this inclusion criterion is only applicable until 75 subjects with prior exposure to biologic therapy have been randomized).
    5. If subjects are receiving the following CD treatments, they must be on a stable dose for at least 1 month prior to randomization: 5-aminosalicylates (5-ASAs) (not exceeding 4.8 g per day) or oral corticosteroids (not exceeding prednisone 20 mg/day, budesonide 9 mg/day, or equivalent).
    6. If subjects are receiving bile-salt sequestrant, they must be on a stable dose for at least 3 months prior to randomization.
    7. If subjects are receiving any nonprohibited medications, they must agree to maintain stable doses of concomitant medications for CD for the duration of the trial.
    8. Unlikely to conceive, as defined by 1 of the following: a) subject is a surgically sterilized female, b) subject is a postmenopausal female ≥ 45 years of age with clinical documentation of menopause (i.e., 12 months without menses), or c) subject is male or is a woman of childbearing potential (WOCBP), and agrees to abstain from heterosexual activity, use adequate hormonal contraception, or use double-barrier contraception for 2 weeks after the last study drug administration.
    9. For WOCBP, subject must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study medication.
    10. Able to participate fully in all aspects of this clinical trial.
    11. Written informed consent must be obtained and documented.
    E.4Principal exclusion criteria
    1. A diagnosis of UC.
    2. At imminent risk of ileocolectomy.
    3. Subjects with known current complications of CD defined as any of the following:
    a) Symptomatic bowel stricture.
    b) Ostomy or ileoanal pouch.
    c) Impassable anal or rectal stenoses.
    d) Short gut syndrome.
    e) Other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of response to therapy (CDAI and endoscopic evaluation).
    4. Any recent (within 2 months) abscess, unless it has been drained and treated at least 6 weeks prior to randomization and are not anticipated to require surgery. Subjects with nondraining perianal fistulas may be included provided there is no anticipated need for surgery and there are currently no abscesses present.
    5. Any history of bowel resection or diversion within 3 months prior to screening.
    6. Treatment with total parenteral nutrition within 2 weeks of screening.
    7. Treatment with an immunosuppressant (azathioprine, 6-mercaptopurine [6-MP], methotrexate) within 25 days prior to randomization.
    8. Treatment with efalizumab, or agents that deplete B or T cells (rituximab, alemtuzumab, or visilizumab) within 6 months of screening, or if after receiving these agents at any time prior to the study, evidence is available at screening of persistent depletion of the targeted lymphocyte population.
    9. Regular daily use of opioids for medical reasons within 3 months prior to randomization.
    10. Treatment with rectal 5-ASA compounds or intravenous or rectal corticosteroids within 4 weeks prior to randomization.
    11. Treatment with oral corticosteroids prednisone equivalent dose > 20 mg/day, or > 9 mg/day of budesonide, or any changes to dose within the 4 weeks prior to randomization.
    12. Treatment with antibiotics for CD within 1 month prior to screening.
    13. Treatment with any investigational or approved biologic for CD within 8 weeks prior to randomization (or within 4 weeks prior to randomization, if no detectable drug levels confirmed by validated or commercial assay).
    14. Treatment with any investigational or approved nonbiologic therapies for CD within 4 weeks prior to randomization.
    15. Use of apheresis (e.g., Adacolumn apheresis) ≤ 2 weeks prior to screening.
    16. Current bacterial or parasitic pathogenic enteric infection, including Clostridioides difficile, known infection with hepatitis B or C virus, known infection with human immunodeficiency virus, infection requiring hospitalization or intravenous 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.
    17. Any live bacterial or viral vaccination within 12 weeks prior to randomization. Patients must agree not to receive a live virus or bacterial vaccination during the study or up to 12 months after the last administration of study drug.
    18. Bacille Calmette–Guérin vaccination within 12 months of screening.
    19. Current or previous colonic dysplasia, with the exception of completely resected adenomatous polyps.
    20. Fecal microbiota transplantation within 1 month prior to screening.
    21. A concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder.
    22. Known primary or secondary immunodeficiency.
    23. History of myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (New York Heart Association [NYHA] Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, stroke, uncontrolled hypertension, or uncontrolled diabetes within 6 months of screening.
    24. Clinically significant laboratory abnormalities at screening, as determined and documented by the investigator.
    25. Pregnant or lactating females.
    26. History of major surgery within 3 months prior to screening or planned major surgery during the study
    27. History of malignant neoplasms or carcinoma in situ (except for basal cell or in situ squamous cell carcinomas of the skin that have been excised or resolved) within 5 years prior to screening
    28. Current or recent history of alcohol dependence or illicit drug use.
    29. Mental or legal incapacitation at the time of screening visit or a history of clinically significant psychiatric disorders
    30. Unable to attend study visits or comply with procedures.
    31. Concurrent participation in any other interventional study.
    32. Received any investigational therapy within 30 days of initiation of study drug.
    33. Previous exposure to BT-11.
    34. Prior enrollment in the current study and had received study treatment.
    35. Treatment with sirolimus within 4 weeks prior to randomization.
    36. A positive COVID-19 test, or exposure to COVID-19 patients.

    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoints:
    1. Proportion of subjects achieving clinical remission at Week 12, defined by CDAI < 150;
    2. Frequency and severity of AEs compared to placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At weeks R, 2, 6, 12 ,18, 24, 30
    2. Record adverse events from the time of the signing of the informed consent until the end of the study
    E.5.2Secondary end point(s)
    Key (ranked) secondary endpoints:
    1. Proportion of subjects with an endoscopic response at Week 12, defined by a 50% reduction from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD) score
    2. Endoscopic remission (SES-CD of 0-2 or SES-CD ≤ 4, a ≥ 2-point improvement from baseline, and no subscore > 1) at Week 12
    3. Proportion of subjects achieving histologic remission (Geboes score < 2B.1 [with absence of neutrophils in lamina propria]) at Week 12
    4. Clinical response (CDAI reduction from baseline ≥ 100 points or CDAI < 150) at Week 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Screening, Week 12, 30
    2. Screening, Week 12, 30
    3. Screening, Week 12, 30
    4. Week R, 2, 6, 12 ,18, 24, 30
    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. 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Bosnia and Herzegovina
    North Macedonia
    Moldova, Republic of
    United States
    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
    The End-of-Study is defined as the end of the posttreatment safety follow-up visit, 2 weeks after the last dose of study drug at the end of the maintenance period (or after the last dose in the induction period for subjects who do not continue in the maintenance period).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 150
    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)
    The investigator will ensure that poststudy care of the participant is considered.
    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 Decision2021-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-10
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