protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03737812 | 5.3 | Prohibited Medications and Therapy | 5.3 Prohibited Medications and Therapy In addition to the medications listed in the eligibility criteria, prior exposure to any of the following is NOT allowed: - 1. No prior treatment with the any of the following: - Total lymphoid irradiation - Cladribine or mitoxantrone - T cell or T cell receptor vaccination - Stem... | [] |
NCT03737812 | 5.4 | Prior and Concomitant Therapy | 5.4 Prior and Concomitant Therapy Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, and/or herbal supplements) that the subject received since 30 days before Screening or receives during the study must be recorded through the post-treatment visit (Week 76). Non-immunomodulatory ... | [] |
NCT03737812 | 5.5 | Withdrawal of Subjects and Discontinuation of Study | 5.5 Withdrawal of Subjects and Discontinuation of Study A subject may voluntarily withdraw or be withdrawn from the study at any time for reasons including, but not limited to, the following:  - Clinically significant abnormal laboratory results or AEs, which rule out continuation of the study d... | [
"COVID-19 Pandemic-Related Acceptable Protocol Modifications",
"Interruption/Discontinuation of Study Drug Due to COVID-19 Infection"
] |
NCT03737812 | 5.6 | Follow-Up After Subject Discontinuation of Study Drug or from Study | 5.6 Follow-Up After Subject Discontinuation of Study Drug or from Study If a subject prematurely discontinues study participation (withdrawal of informed consent), the procedures outlined for the Early-Discontinuation (ED) Visit should be completed as soon as possible, preferably within 2 weeks. In addition, if subject... | [] |
NCT03737812 | 5.7 | Study Drug | 5.7 Study Drug Elezanumab (ABT-555) is manufactured by AbbVie as shown in [Table](#page-20-1) 1, below. For subjects randomized to the treatment arms, the solution contained in the study vial(s) of ABT-555 will be diluted in the 0.9% Sodium Chloride Injection/Solution for Infusion.  Table 1. Stu... | [
"Treatment Administration",
"Table 2. Study Drug Administration Schedule",
"Packaging and Labeling",
"Storage and Disposition of Study Drug",
"Subject Identifier Assignment",
"Timing of Dose for Each Subject",
"Study Drug Accountability",
"Study Blinding"
] |
NCT03737812 | 5.8 | Randomization/Drug Assignment | 5.8 Randomization/Drug Assignment Subjects will be randomized in a 1:1:1 ratio to one of two doses of elezanumab or placebo according to the randomization schedule generated by the Abbvie statistics department. An IRT system will be used to assign subject numbers and drug kits in accordance with the subject's assigned ... | [] |
NCT03737812 | 5.9 | Protocol Deviations | 5.9 Protocol Deviations AbbVie does not allow intentional/prospective deviations from the protocol except when necessary to eliminate an immediate hazard to study subjects. The investigator is responsible for complying with all protocol requirements, written instructions, and applicable laws regarding protocol deviatio... | [] |
NCT03737812 | 6 | SAFETY CONSIDERATIONS | 6 SAFETY CONSIDERATIONS | [] |
NCT03737812 | 6.1 | Complaints and Adverse Events | 6.1 Complaints and Adverse Events
Complaints A complaint is any written, electronic, or oral communication that alleges deficiencies related to the physical characteristics, identity, quality, purity, potency, durability, reliability, safety, effectiveness, or performance of a product/device. Complaints associated wit... | [
"Complaints",
"Product Complaint",
"Medical Complaints/Adverse Events and Serious Adverse Event",
"Adverse Event Severity and Relationship to Study Drug",
"Adverse Events of Special Interest",
"Pregnancy"
] |
NCT03737812 | 7 | STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE | 7 STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE | [] |
NCT03737812 | 7.1 | Statistical and Analytical Plans | 7.1 Statistical and Analytical Plans Complete and specific details of the statistical analysis will be described and fully documented in the statistical analysis plan (SAP). The SAP will be finalized before the interim database lock. The statistical analyses will be performed using SAS (SAS Institute Inc., Cary, North ... | [] |
NCT03737812 | 7.2 | Definition for Analysis Sets | 7.2 Definition for Analysis Sets The Modified ITT (mITT) Set includes all randomized subjects who received at least 1 dose of study drug. Subjects will be grouped according to treatment as randomized. Multiple sclerosis expert(s) will confirm which subjects experienced a clinical relapse(s) through adjudication of stud... | [] |
NCT03737812 | 7.3 | Statistical Analyses for Efficacy | 7.3 Statistical Analyses for Efficacy The ORS scores will be summarized descriptively (including n, mean, standard deviation, minimum, median, and maximum) along with the 95% confidence interval at each visit. The frequency and percentage of ORS for –4 to +4 will also be provided by treatment group at each visit. The O... | [
"Sample Size Estimation"
] |
NCT03737812 | 7.4 | Statistical Analyses for Safety | 7.4 Statistical Analyses for Safety Analysis of the following safety evaluations will be performed during the study: Adverse events and SAEs; vital signs, laboratory tests, ECG, physical and neurologic examinations, and C-SSRS assessments. Complete and specific details of the statistical analysis of safety evaluations ... | [] |
NCT03737812 | 7.5 | Interim Analysis | 7.5 Interim Analysis There are no interim efficacy or futility analyses. | [] |
NCT03737812 | 7.6 | Subgroup Analysis | 7.6 Subgroup Analysis The primary efficacy analyses will also be performed in the following subgroups to assess the consistency of the treatment effect: - Sex (male, female) - Age (≤ 40 years, > 40 years) - EDSS baseline (≤ median, > median) - Diagnosis of MS form (primary-progressive [PPMS], SPMS) - Presence of backgr... | [] |
NCT03737812 | 8 | ETHICS | 8 ETHICS | [] |
NCT03737812 | 8.1 | Independent Ethics Committee/Institutional Review Board | 8.1 Independent Ethics Committee/Institutional Review Board The protocol, informed consent form(s), recruitment materials, and all subject materials will be submitted to the Independent Ethics Committee/Institutional Review Board (IEC/IRB) for review and approval. Approval of both the protocol and the informed consent ... | [] |
NCT03737812 | 8.2 | Ethical Conduct of the Study | 8.2 Ethical Conduct of the Study The study will be conducted in accordance with the protocol, Operations Manual, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, applicable regulations, and guidelines governing clinical study conduct and the ethical p... | [] |
NCT03737812 | 8.3 | Subject Confidentiality | 8.3 Subject Confidentiality To protect subjects' confidentiality, all subjects and their associated samples will be assigned numerical study identifiers or "codes." No identifiable information will be provided to AbbVie. | [] |
NCT03737812 | 9 | SOURCE DOCUMENTS AND CASE REPORT FORM COMPLETION | 9 SOURCE DOCUMENTS AND CASE REPORT FORM COMPLETION The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported. All source documents should be attributable, legible, contemporaneous, original, accurate, and complete to ensure accurate interpretation of data. ... | [] |
NCT03737812 | 10 | DATA QUALITY ASSURANCE | 10 DATA QUALITY ASSURANCE AbbVie will ensure that the clinical trial is conducted with a quality management system that will define quality tolerance limits in order to ensure human subject protection and reliability of study results. Data will be generated, documented, and reported in compliance with the protocol, ICH... | [] |
NCT03737812 | 11 | COMPLETION OF THE STUDY | 11 COMPLETION OF THE STUDY The end-of-study is defined as the date of the last subject's last visit. | [] |
NCT03737812 | 12 | REFERENCES | 12 REFERENCES 1. AbbVie. Elezanumab Investigator's Brochure. 
APPENDIX A. STUDY-SPECIFIC ABBREVIATIONS AND TERMS Abbreviation Definition ADA Anti-drug antibody AE Adverse event AESI Adverse events of special interest ALT Alanine transaminase ANC Absolute neutrophil count ATEMS AbbVie Temperatur... | [
"APPENDIX A. STUDY-SPECIFIC ABBREVIATIONS AND TERMS",
"APPENDIX B. RESPONSIBILITIES OF THE INVESTIGATOR",
"APPENDIX C. LIST OF PROTOCOL SIGNATORIES",
"APPENDIX D. ACTIVITY SCHEDULE",
"APPENDIX E. PROTOCOL SUMMARY OF CHANGES",
"Previous Protocol Versions",
"Protocol Summary of Changes",
"Rationale:"
] |
NCT03738475 | 3 | 3. f T | 3. 3. f T y o - 0D[LPDOREVHUYHGFRQFHQWUDWLRQ&PD[ - 7LPHRIPD[LPDOREVHUYHGFRQFHQWUDWLRQ7PD[ - \$UHDXQGHUWKHFRQFHQWUDWLRQWLPHFXUYH\$8& IURPWLPH]HURDQGH[WUDSRODWHGWRLQILQLW\ \$8&LQI \$8&IURPWLPH]HURWRWLPHRIWKHODVWPHDVXUDEOHFRQFHQWUDWLRQ\$8&ODVW Property of Takeda: For -commerci JOLDGLQ 'HFHPEHU 3DJHRI
Safety: - AEs and se... | [
"Safety:",
"Statistical Methods:",
"Analyses:",
"Efficacy/Pharmacodynamics:",
"PK:",
"Safety:",
"LIST OF ABBREVIATIONS",
"1 INTRODUCTION",
"1.1 Background on Indication",
"1.2 Limitations of Current Treatments",
"1.3 TIMP-GLIA",
"1.4 Nonclinical Pharmacology and Toxicology Studies",
"1.4.1 N... |
NCT03738475 | 3.2.2 | Selection of Population | 3.2.2 Selection of Population The study population consists of patients with biopsy-confirmed, asymptomatic CD and following a GFD. This study population reflects a population most likely to respond to a gluten challenge. | [] |
NCT03738475 | 3.2.3 | Selection of Dose | 3.2.3 Selection of Dose In the Phase 1 study (Section 1.5) the TIMP-GLIA dose of 8 mg/kg up to a maximum of 650 mg was the highest dose tolerated, thus will be evaluated for pharmacodynamics and efficacy in this study. | [] |
NCT03738475 | 3.3 | Date Monitoring Committee | 3.3 Date Monitoring Committee An independent DMC will be commissioned for this study. The DMC will be comprised of 3 physicians with expertise in CD, immunology, and interventional clinical trials. The DMC safety monitoring plan will be detailed in the DMC Charter. The primary responsibility of the DMC is to safeguard ... | [] |
NCT03738475 | 3.4 | Subject Participation and Study Duration | 3.4 Subject Participation and Study Duration The total duration of enrollment is estimated to be 3-4 months. The duration of each subject's participation (including Screening) is approximately 78 days (11 weeks). Thus, the study is expected to last approximately 7 months. 10 December 2018 Page 22 of 62 | [] |
NCT03738475 | 4 | SUBJECT POPULATION | 4 SUBJECT POPULATION Approximately 30 subjects who meet the eligibility criteria will be enrolled. | [] |
NCT03738475 | 4.1 | Inclusion Criteria | 4.1 Inclusion Criteria - 1. Male or nonpregnant female, ages 18 to 70 years inclusive, at Screening Visit. - 2. Biopsy-confirmed CD (intestinal histology showing villous atrophy). - 3. Positive for HLA-DQ2 or HLA-DQ2/DQ8 results will be obtained at Screening if unknown or results are not available. - 4. Self-reported t... | [] |
NCT03738475 | 4.2 | Exclusion Criteria | 4.2 Exclusion Criteria 1. Positive for only HLA-DQ8. 10 December 2018 Page 23 of 62 - 2. History of clinically confirmed immunoglobulin E (IgE)-mediated reaction and/or anaphylaxis to wheat (i.e., "wheat allergy"), barley or rye. - 3. Uncontrolled CD and/or active signs/symptoms of CD, in the opinion of the investigato... | [] |
NCT03738475 | 4.3 | Subject and Study Discontinuation | 4.3 Subject and Study Discontinuation A clear distinction will be made between subjects who are withdrawn from dosing and those who prematurely discontinue from the study. Only those subjects who withdraw consent or refuse any further contact with respect to the study will be discontinued from the study. Subjects withd... | [] |
NCT03738475 | 4.3.1 | Screening Failures | 4.3.1 Screening Failures Subjects who sign and date the informed consent form (ICF) but who fail to meet the inclusion and exclusion criteria are defined as screen failures. A screening log, which documents the subject's initials and reason(s) for screen failure, is to be maintained for all screen failures. A copy of t... | [] |
NCT03738475 | 4.3.2 | Premature Discontinuation from Investigational Product | 4.3.2 Premature Discontinuation from Investigational Product A subject may be prematurely discontinued from IP dosing for any of the following reasons: - Safety, including AEs or development of clinically significant laboratory abnormalities. The subject must be followed clinically until the event is resolved or deemed... | [] |
NCT03738475 | 4.3.3 | Premature Discontinuation from Study | 4.3.3 Premature Discontinuation from Study A subject may be prematurely discontinued from the study for any of the following reasons: 10 December 2018 Page 25 of 62 - Subject wishes to withdraw consent for reasons other than an AE. - Subject is lost to follow-up. - Subject non-compliance or unwillingness to comply with... | [] |
NCT03738475 | 4.3.4 | Replacement of Subjects | 4.3.4 Replacement of Subjects Subjects who do not complete all study procedures, per protocol, through Day 29 (complete 14 day gluten challenge and second biopsy) may be replaced. | [] |
NCT03738475 | 4.3.5 | Study or Site Termination | 4.3.5 Study or Site Termination Conditions may arise during the study that could prompt the study to be halted or the study site to be terminated. Conditions that may prompt such considerations include, but are not limited to, the following: Property of Takeda: For non-commercial use only and subject to the applicable ... | [] |
NCT03738475 | 5 | INVESTIGATIONAL PRODUCT | 5 INVESTIGATIONAL PRODUCT | [] |
NCT03738475 | 5.1 | TIMP-GLIA | 5.1 TIMP-GLIA TIMP-GLIA is comprised of gliadin extract within a negatively charged (-35mV to -50mV) polymer matrix of PLGA particles with an average size between 400 nm – 800 nm. There is approximately 10 μg of refined gliadin per mg of PLGA particles. Prior to IV administration, TIMP-GLIA is reconstituted in sterile ... | [] |
NCT03738475 | 5.1.1 | Packaging and Labeling | 5.1.1 Packaging and Labeling TIMP-GLIA is manufactured, packaged, and labeled by the Sponsor's designee(s) in accordance with legal and regulatory requirements. TIMP-GLIA is supplied as a lyophilized powder in a single-use, 20-mL glass vial containing approximately 1 mg refined gliadin and 100 mg of PLGA particles. Via... | [] |
NCT03738475 | 5.1.2 | Storage | 5.1.2 Storage TIMP-GLIA vials should be stored at 2°C to 8℃ (36°F to 46°F) and protected from light in a secure, temperature-monitored, limited access location. A daily temperature log must be maintained and temperature excursions documented. | [] |
NCT03738475 | 5.2 | Placebo | 5.2 Placebo The placebo for this study is 0.9% Sodium Chloride Injection USP (normal saline). Placebo should be stored at ambient room temperature in accordance with the product label. | [] |
NCT03738475 | 5.3 | Preparation of Investigational Product | 5.3 Preparation of Investigational Product Preparation of the TIMP-GLIA and placebo must be performed by a designated unblinded site pharmacist (or otherwise qualified personnel) in accordance with the Pharmacy Manual provided by the Sponsor. Dose will be determined by subject weight on Day 1. | [] |
NCT03738475 | 5.4 | Blinding and Unblinding | 5.4 Blinding and Unblinding Investigators, subjects, and all study staff with direct subject contact will be blinded to treatment assignment. A designated unblinded pharmacist (or otherwise qualified personnel) at each site 10 December 2018 Page 27 of 62 will prepare each dose. That individual should have no contact wi... | [] |
NCT03738475 | 5.5 | Administration of Investigational Product | 5.5 Administration of Investigational Product TIMP-GLIA or placebo will be administered by unblinded, trained study personnel. TIMP-GLIA or placebo will be administered at the following escalating rates: - 20 mL per hour for 15 minutes, then - 40 mL per hour for the next 15 minutes, then - 80 mL per hour for the durati... | [] |
NCT03738475 | 5.6 | Management of Infusion Reactions | 5.6 Management of Infusion Reactions Subjects must be monitored closely for signs and symptoms of an IR. In the event of an IR, the infusion should be slowed, or stopped and restarted at a slower rate at the discretion of the Investigator. If a severe IR occurs (Grade 3 or 4 signs or symptoms), discontinue infusion and... | [] |
NCT03738475 | 5.7 | Gluten Challenge | 5.7 Gluten Challenge Bob's Red Mill Vital Wheat Gluten (75-80% Protein) powder will be used for the gluten challenge. It will be supplied by the sponsor in individual foil packets, each containing approximately 6 g gluten (approximately 8.5 g of powder) per packet. Subjects will consume 12 g of gluten for the first 3 d... | [] |
NCT03738475 | 5.8 | Investigational Product and Wheat Gluten Accountability, Dispensing, and Destruction | 5.8 Investigational Product and Wheat Gluten Accountability, Dispensing, and Destruction The Investigator (or designee) will maintain an accurate record of the receipt of the IP and wheat gluten as shipped by the Sponsor (or designee), including the date received. In addition, an accurate IP/wheat gluten disposition re... | [] |
NCT03738475 | 5.9 | Prior and Concomitant Medications | 5.9 Prior and Concomitant Medications Subjects may not receive a live vaccine within 28 days prior or a subunit vaccine within 14 days prior to Day 1 or planned vaccination prior to Day 35. All prior and concomitant medications, including prescription and nonprescription medicines, will be reported in the eCRF beginnin... | [] |
NCT03738475 | 5.10 | Other Study Restrictions | 5.10 Other Study Restrictions | [] |
NCT03738475 | 5.10.1 | Food and Fluid Intake | 5.10.1 Food and Fluid Intake With the exception of the gluten challenge (Days 15-28) subjects must adhere to a gluten free diet throughout the study. There are no other restrictions on food or fluid intake during the 10 December 2018 Page 29 of 62 study. Because of the large volume of whole blood drawn for isolation of... | [] |
NCT03738475 | 5.10.2 | Subject Activity Restrictions | 5.10.2 Subject Activity Restrictions To reduce the occurrence of exercise induced elevated creatine kinase, subjects should be instructed to refrain from excessive physical activity (as defined by the Investigator) for 48 hours before each study visit. | [] |
NCT03738475 | 5.10.3 | Birth Control | 5.10.3 Birth Control Men and WOCBP must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal me... | [] |
NCT03738475 | 5.11 | Treatment Compliance | 5.11 Treatment Compliance To ensure compliance with the dosing regimen, all doses will be administered at the investigational site by trained study personnel who have been delegated that responsibility by the Investigator. Subjects will be observed consuming the wheat gluten on the first day of the challenge and report... | [] |
NCT03738475 | 6 | STUDY PROCEDURES | 6 STUDY PROCEDURES Refer to Appendix 1 for the Schedule of Events. | [] |
NCT03738475 | 6.1 | Definitions and Descriptions of Assessments and Procedures | 6.1 Definitions and Descriptions of Assessments and Procedures CD history – CD history should include date of diagnosis, date of biopsy proven diagnosis,, and date subject started GFD. A copy of the biopsy must be maintained in the subject's medical record. CSI-M – modified celiac symptoms index (Appendix 3); to be use... | [] |
NCT03738475 | 6.2 | Screening | 6.2 Screening Subjects will be screened to assess eligibility criteria within 45 days prior to Study Day 1 (first dose of IP). Prior to performing the assessments below, it is important to obtain the Subject ID from iMedNet eCRF. The following assessments and procedures will be performed: - Written informed consent - M... | [] |
NCT03738475 | 6.3 | Randomization | 6.3 Randomization Upon determination that a subject meets all eligibility criteria, the subject will be randomized to treatment assignment. Randomization should occur via eCRF on Study Day 1 just prior to IP administration. Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use | [] |
NCT03738475 | 6.4 | On-Study Procedures | 6.4 On-Study Procedures | [] |
NCT03738475 | 6.4.1 | Study Days 1 (Dose 1) and 2 | 6.4.1 Study Days 1 (Dose 1) and 2 This visit will take approximately 5 hours, including observation for 2 hours after dosing. The following procedures will be performed prior to IP administration: - Weight to be used to calculate dose - Symptom-driven physical exam - Vital signs - Laboratory Assessments, including: - S... | [] |
NCT03738475 | 6.4.2 | Study Days 8 (Dose 2) and 9 | 6.4.2 Study Days 8 (Dose 2) and 9 This visit will take approximately 5 hours, including observation for 2 hours after dosing. The following procedures will be performed prior to IP administration: Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use - Symptom-driven physical exam -... | [
"IP administration"
] |
NCT03738475 | 6.4.3 | Study Day 15 – Beginning of Gluten Challenge | 6.4.3 Study Day 15 – Beginning of Gluten Challenge This visit will take approximately 2 hours, including observation for 1 hour after consuming the wheat gluten. The following procedures will be performed prior to consuming wheat gluten. Property of Takeda: For non-commercial use only and subject to the applicable Term... | [] |
NCT03738475 | 6.4.4 | Study Day 20 | 6.4.4 Study Day 20 This visit will take approximately 1 hour and after the subject has consumed their daily wheat gluten. The following procedures will be performed: - Assessment of adherence to gluten challenge - Symptom-driven physical exam - Vital signs - Laboratory Assessments, including: - Serum chemistries - Hema... | [] |
NCT03738475 | 6.4.5 | Study Day 29 | 6.4.5 Study Day 29 This visit will take approximately 3 hours, including the biopsy. The following procedures will be performed: Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use - Small bowel biopsy the biopsy may be performed on Day 28 or Day 29 - Assessment of adherence to gl... | [] |
NCT03738475 | 6.4.6 | Study Day 35 (± 1 day) or Early Termination | 6.4.6 Study Day 35 (± 1 day) or Early Termination This visit will take approximately 1 hour. The following procedures will be performed: 10 December 2018 Page 35 of 62 - Symptom-driven physical exam - Vital signs - Laboratory Assessments, including: - Serum chemistries - Hematology - Serum pregnancy test for WOCBP - C1... | [] |
NCT03738475 | 6.5 | Research Storage Samples | 6.5 Research Storage Samples Approximately 3 mL of blood will be collected on Days 1, 2, 8, and 9, frozen and stored. In addition, 4 biopsy samples will be collected at the time of each biopsy. These stored samples may be used by the Sponsor or its research partners for celiac or celiac-related disease, for retesting o... | [] |
NCT03738475 | 7 | ADVERSE EVENTS | 7 ADVERSE EVENTS AEs will be reported in a manner consistent with the FDA Guidance for Industry and Investigators, "Safety Reporting Requirements for IND and BA/BE Studies," December 2012 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM227351.pdf). | [] |
NCT03738475 | 7.1 | Reporting Responsibilities | 7.1 Reporting Responsibilities All AEs will be recorded in the eCRF, from Study Day 1 through Study Day 35. It is the responsibility of the Investigator or Subinvestigator(s) to perform periodic assessment of all AEs. Data describing AEs, including SAEs, will be entered in the subject's medical record and eCRF. SAEs wi... | [] |
NCT03738475 | 7.2 | Definitions | 7.2 Definitions | [] |
NCT03738475 | 7.2.1 | Adverse Event | 7.2.1 Adverse Event An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory fi... | [] |
NCT03738475 | 7.2.2 | Serious Adverse Event | 7.2.2 Serious Adverse Event An AE or suspected adverse reaction is considered "serious" (SAE) if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: - Death - Life-threatening - An AE is considered "life-threatening" if, in the view of either the Investigator or Sponsor, its... | [] |
NCT03738475 | 7.2.3 | Relatedness (Causality) | 7.2.3 Relatedness (Causality) Causality assessment is required for AEs (and SAEs) that occur during clinical investigations. There is currently no standard international nomenclature to describe the degree of causality or relatedness of an AE with the IP. The following terms will be used during this study: - Likely Rea... | [] |
NCT03738475 | 7.2.4 | Severity | 7.2.4 Severity Severity will be reported in accordance with the Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (Appendix 2, Toxicity Grading Scale). Property of Takeda: For n[on-co](#page-52-0)mmercial use only and subject to the... | [] |
NCT03738475 | 7.3 | Clinical Laboratory Abnormalities | 7.3 Clinical Laboratory Abnormalities Any laboratory abnormality deemed clinically significant by the Investigator should be reported as an AE. A clinically significant abnormality is a confirmed abnormality (by repeat test) that is 10 December 2018 Page 38 of 62 changed sufficiently from Screening/Baseline so that in ... | [] |
NCT03738475 | 7.4 | Physical Exam Abnormalities | 7.4 Physical Exam Abnormalities Any physical exam abnormality deemed clinically significant by the Investigator at Day 1 should be reported as medical history. Any new physical exam abnormality deemed clinically significant by the Investigator during the study should be reported as an AE. | [] |
NCT03738475 | 7.5 | Pregnancy | 7.5 Pregnancy No additional doses should be administered to a subject who becomes pregnant during the conduct of the trial. All remaining safety assessments should be performed. All pregnancies that occur –including female partners of male subjects – during the study must be reported to the Sponsor and followed to conc... | [] |
NCT03738475 | 7.6 | Reporting of Serious Adverse Events | 7.6 Reporting of Serious Adverse Events SAEs must be reported to the Sponsor or designee within 1 business day of becoming aware of the event by entering the data on the AE eCRF. If at the time the Investigator submits an initial SAE report the event has not resolved, the Investigator must provide a follow-up as soon a... | [] |
NCT03738475 | 7.7 | Toxicity Management | 7.7 Toxicity Management All clinical and clinically significant laboratory AEs (i.e., toxicities) will be managed as outlined below. - Clinical and clinically significant laboratory abnormalities will be graded according to the Toxicity Grading Scale in Appendix 2. - Grade 3 and 4 clinically significant laboratory abno... | [] |
NCT03738475 | 7.7.1 | Suspected Drug-Induced Liver Injury | 7.7.1 Suspected Drug-Induced Liver Injury - For any ALT or AST > 3x the upper limit of normal (ULN), the results will be confirmed by repeat testing within 3 calendar days of receipt of results and prior to further administration of IP. Testing for AP, TBL, direct bilirubin, and international normalized ratio (INR) wil... | [] |
NCT03738475 | 7.7.2 | Other Grades 1 and 2 Laboratory Abnormality or Clinical Event | 7.7.2 Other Grades 1 and 2 Laboratory Abnormality or Clinical Event Administer IP at the discretion of the Investigator. If the event is an IR, follow instructions outlined in Section 5.6. | [] |
NCT03738475 | 7.7.3 | Other Grade 3 Laboratory Abnormality or Clinical Event | 7.7.3 Other Grade 3 Laboratory Abnormality or Clinical Event - For Grade 3 clinically significant laboratory abnormality or clinical event, IP may be administered if the event is considered to be Unlikely related to IP. - For a Grade 3 clinical event, or clinically significant laboratory abnormality confirmed by repeat... | [] |
NCT03738475 | 7.7.4 | Other Grade 4 Laboratory Abnormality or Clinical Event | 7.7.4 Other Grade 4 Laboratory Abnormality or Clinical Event For a Grade 4 clinical event or clinically significant Grade 4 laboratory abnormality confirmed by repeat testing that is considered to be Likely related to IP, IP will be permanently discontinued and the subject managed according to local practice. The subje... | [] |
NCT03738475 | 8 | STATISTICAL CONSIDERATIONS | 8 STATISTICAL CONSIDERATIONS | [] |
NCT03738475 | 8.1 | Sample Size | 8.1 Sample Size For the primary efficacy endpoint, using a 2-sided 0.05 significance level, a statistical power of ~70%, and assuming an increase in mean IFN- ɣ SFUs in the placebo group of 75 (standard deviation [SD] 100) and in the TIMP-GLIA group of 5 (SD 10), 15 subjects per group will allow detection of a differen... | [] |
NCT03738475 | 8.2 | Analysis Conventions | 8.2 Analysis Conventions Planned statistical analyses will be detailed in the Statistical Analysis Plan (SAP). This plan will be finalized prior to locking of the final data set and unblinding of results. The general principles are outlined below. Ad hoc exploratory analyses may be performed in addition to those specif... | [] |
NCT03738475 | 8.3 | Analysis Populations | 8.3 Analysis Populations The following populations will be used for analysis of the study data. Safety population: All randomized subjects who receive at least 1 dose of IP. Subjects will be analyzed according to the treatment actually received. PK population: All randomized subjects who receive 2 doses of IP. Subjects... | [] |
NCT03738475 | 8.4 | Demographic Data and Baseline Characteristics | 8.4 Demographic Data and Baseline Characteristics Demographic and baseline characteristics will be summarized by treatment group and consist of (but not limited to) the following: age, height, weight, sex, ethnicity/race, and CD history. 10 December 2018 Page 42 of 62 Additionally, the number and percent of subjects wi... | [] |
NCT03738475 | 8.5 | Pharmacodynamic Analyses | 8.5 Pharmacodynamic Analyses The mean changes from baseline in IFN-γ SFUs within and between treatment groups will be compared using a Wilcoxon Signed Rank Test and a Wilcoxon Rank Sum Test, respectively. The proportion of subjects with a 2-fold increase from baseline (and an increase of at least 10) in IFN-γ SFUs in t... | [] |
NCT03738475 | 8.6 | Histology Analyses | 8.6 Histology Analyses The mean changes from baseline in villus height, crypt depth, and their ratio (Vh:Cd) within and between treatment groups will be compared using a Wilcoxon Signed Rank Test and a Wilcoxon Rank Sum Test, respectively. The proportion of subjects with a decrease of ≥ 0.4 in Vh:Cd in the placebo and ... | [] |
NCT03738475 | 8.7 | Celiac Signs and Symptoms | 8.7 Celiac Signs and Symptoms Subject responses to the CSI-M will be summarized using descriptive statistics. | [] |
NCT03738475 | 8.8 | Pharmacokinetic Analyses | 8.8 Pharmacokinetic Analyses Individual subject TIMP-GLIA concentrations and derived PK parameters will be summarized using descriptive statistics, including coefficient of variation.. | [] |
NCT03738475 | 8.9 | Safety Analyses | 8.9 Safety Analyses | [] |
NCT03738475 | 8.9.1 | Adverse Events | 8.9.1 Adverse Events All AEs will be coded using the Medical Dictionary for Regulatory Affairs (MedDRA). Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to discontinu... | [] |
NCT03738475 | 8.9.2 | Laboratory Evaluations and Vital Signs | 8.9.2 Laboratory Evaluations and Vital Signs Quantitative data (e.g. clinical lab results) will be summarized by mean, median, SD, and range. Laboratory abnormalities will be analyzed as safety outcomes by summarizing frequency, severity, and changes from baseline. Other analyses may include but are not limited to the ... | [] |
NCT03738475 | 8.9.3 | Concomitant Medications | 8.9.3 Concomitant Medications Concomitant medications will be coded using the most current World Health Organization (WHO) drug dictionary and summarized by drug class and medication term, with results presented by treatment group. | [] |
NCT03738475 | 8.10 | Interim Analysis | 8.10 Interim Analysis An interim analysis will be performed when Day 29 data are available for the 30 subjects. The analysis will involve looking at results for change from baseline in IFN-γ SFUs and change from baseline in Vh:Cd. The final sample size will be determined based on the operating characteristics for a dec... | [] |
NCT03738475 | 9 | ETHICAL AND ADMINISTRATIVE RESPONSIBILITIES | 9 ETHICAL AND ADMINISTRATIVE RESPONSIBILITIES | [] |
NCT03738475 | 9.1 | Ethical Conduct of the Study | 9.1 Ethical Conduct of the Study The procedures set out in this study protocol, pertaining to the conduct, evaluation, and documentation of this study, are designed to ensure that the Sponsor, its authorized US representative and Investigator abide by good clinical practice (GCP) as described in the ICH guideline E6, a... | [] |
NCT03738475 | 9.2 | Institutional Review Board Approval | 9.2 Institutional Review Board Approval This protocol and the ICF and any subsequent modifications will be reviewed and approved by the relevant IRB responsible for oversight of the study. A letter from the IRB indicating approval of the study to be conducted by the Investigator will be provided to the Sponsor prior to... | [] |
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