protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03738475 | 9.3 | Informed Consent | 9.3 Informed Consent The ICF document must be signed and dated prior to the initiation of study-related tests, and prior to administration of IP. The original signed ICF for each participating subject shall be filed with records kept by the Investigators. A copy of the ICF must be provided to the subject. If applicable... | [] |
NCT03738475 | 9.4 | Confidentiality | 9.4 Confidentiality Personal study subject data collected and processed for the purposes of this study should be managed by the Investigator and his/her staff with adequate precautions to ensure the confidentiality of those data, and in accordance with applicable national and/or local laws and regulations on personal d... | [] |
NCT03738475 | 9.5 | Protocol Amendments | 9.5 Protocol Amendments Any changes to the protocol will be made in writing by the Sponsor in the form of a protocol amendment. All protocol amendments will be sent to the Investigator, who is responsible for submitting the amendment to the IRB for approval. 10 December 2018 Page 45 of 62 | [] |
NCT03738475 | 9.6 | Case Report Forms | 9.6 Case Report Forms An eCRF will be used to record subject data specified by this protocol. The eCRF must be completed by designated and trained study personnel. The eCRF will be signed by the Investigator or a Sub-Investigator listed on the Form FDA 1572. It is the responsibility of the Investigator to ensure the eC... | [] |
NCT03738475 | 9.7 | Source Document Maintenance | 9.7 Source Document Maintenance Source documents are defined as the results of original observations and activities of a clinical investigation. Source documents may include, but are not limited to, study progress notes, email correspondences, computer printouts, laboratory data, and drug accountability records. All so... | [] |
NCT03738475 | 9.8 | Retention of Records | 9.8 Retention of Records US regulations (21 CFR part 312.62) require that records and documents pertaining to the conduct of this study and the distribution of investigational drugs including medical records, eCRFs, ICFs, test results, and IP records be kept on file by the Investigator for 2 years after a marketing app... | [] |
NCT03738475 | 9.9 | Study Monitoring | 9.9 Study Monitoring Site visits will be conducted by an authorized Sponsor representative (the monitor) to inspect study data, subjects' medical records, and eCRFs in accordance with ICH guidelines, GCPs, and the respective US or national regulations and guidelines, as applicable. It will be the monitor's responsibili... | [] |
NCT03738475 | 9.10 | Protocol Deviations | 9.10 Protocol Deviations Sites are responsible for abiding by their IRB rules and regulations for reporting protocol deviations. Additionally, the following important protocol deviations will be reported in the eCRF: - Subject did not meet study eligibility criteria - Subject did not receive the correct treatment assig... | [] |
NCT03738475 | 9.11 | Financial Disclosure | 9.11 Financial Disclosure Investigators participating in this study will provide accurate financial disclosure information to the Sponsor as required by 21 CFR Part 54. Investigators will update the financial information if any relevant changes occur during the study and for 1 year following completion of the study. | [] |
NCT03738475 | 9.12 | Publication and Disclosure Policy | 9.12 Publication and Disclosure Policy Investigators and their staff shall hold confidential, and not disclose directly or indirectly to any third party other than those persons involved in the study who have a need to know, the protocol, the data arising out of the study, and any other information related to the study... | [] |
NCT03738475 | 10 | REFERENCES | 10 REFERENCES Fasano A, Berti I, Gerarduzzi T, Not T, Colletti RB, Drago S, Elitsur Y, Green PH, Guandalini S, Hill ID, Pietzak M, Ventura A, Thorpe M, Kryszak D, Fornaroli F, Wasserman SS, Murray JA, Horvath K. Prevalence of celiac disease in at-risk and not-at-risk groups in the United States: a large multicenter stu... | [
"\\$SSHQGL[ 6FKHGXOHRI(YHQWV",
"Appendix 2 Toxicity Grading Scale",
"Tables for Clinical Abnormalities",
"Tables for Laboratory Abnormalities",
"Appendix 3 Celiac Symptom Index-Modified (CSI-M)",
"Appendix 4 Amendment to the Protocol",
"Amendment 1, Protocol Version 2.0, XX December 2018",
"Effect on ... |
NCT03753074 | 1.1 | Study Title | 1.1 Study Title A Multinational, Multicenter, open-label, Randomized Controlled Trial to Investigate the Effectiveness of Tenofovir Alafenamide in Reducing Clinical Events in Chronic Hepatitis B Patients beyond Treatment Indications by Current Guidelines (ATTENTION) | [] |
NCT03753074 | 1.2 | Study Phase | 1.2 Study Phase Phase IV (Investigator Initiated Trial)
Study Sites and Investigators
Korea Sites | Study Sites | Investigators | |--------------------------------------------|-------------------| | Asan Medical Center | Young-Suk Lim | | Samsung Medical Center | Wonseok Kang | | Kyung-Hee University Hospital | Gi-Ae... | [
"Study Sites and Investigators",
"Korea Sites",
"Taiwan Sites",
"Purpose and Background"
] |
NCT03753074 | 3.1 | Purpose | 3.1 Purpose To determine whether or not TAF treatment in the patients beyond treatment indications by current guidelines who have high risk of HCC, deaths and events associated with hepatic diseases reduces the incidence of HCC, deaths and events associated with hepatic diseases. | [] |
NCT03753074 | 3.2 | Background | 3.2 Background The goal of treatment for patients with chronic hepatitis B (CHB) is to improve survival by preventing disease progression and HCC.1,2 Ideally, for hepatitis B therapies to be approved, they should demonstrate efficacy in preventing HCC and liver-related deaths. However, these clinical endpoints evolve o... | [
"Study Design",
"Projected Duration of the Study",
"Study Population",
"Study Subjects Criteria (Inclusion/Exclusion)"
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NCT03753074 | 7.1 | Inclusion Criteria | 7.1 Inclusion Criteria - 1) Willing and able to provide written informed consent prior to study entry. - 2) Age ≥40 years and ≤80 years at the time of screening. - 3) Chronic hepatitis B infection defined as HBsAg (+) or HBV DNA (+) for at least 6 months prior to the Screening visit, or the subject is not regarded to h... | [] |
NCT03753074 | 7.2 | Exclusion Criteria | 7.2 Exclusion Criteria - 1) Confirmed known co-infection with HCV, HIV, or HDV - 2) Current alcohol (60g/day) or substance abuse judged by the investigator that will potentially interfere with subject compliance - 3) History or current evidence of clinically hepatic decompensation (e.g., ascites, encephalopathy, varice... | [
"Study Procedures and Methods"
] |
NCT03753074 | 8.1 | Treatment Allocation | 8.1 Treatment Allocation - (1) Treatment Arm (Treatment Arm A): Tenofovir Alafenamide (25mg/day) - (2) Observation Arm (Treatment Arm B): Best supportive care - (3) Allocation Method: An independent statistician will generate the code to randomly allocate participants to either Treatment Arm or Observation Arm in 1:1 r... | [
"(5) Treatment Method: Investigational Product, Administration Method and Dosage"
] |
NCT03753074 | 8.2 | Evaluation Assessments | 8.2 Evaluation Assessments | [] |
NCT03753074 | 8.2.1 | Timetable of the study | 8.2.1 Timetable of the study | | Screening1 | Baseline | | On-Treatment2EOT | | | | | |------------------------------|----------------------|----------|--------------------|----------------------|-----|-----------------------------------------------------|----------------------------------------------------|------| | A... | [] |
NCT03753074 | 8.2.2 | Study Procedures | 8.2.2 Study Procedures
1) Screening visit (Baseline ≤28 days) - - Obtain written informed consent - - Basic information and medical history - - Review of inclusion/exclusion criteria - - Complete physical examination and vital signs - Physical examination: Lower leg edema, Ascites - Vital signs: blood pressure, pulse ... | [
"1) Screening visit (Baseline ≤28 days)",
"2) Baseline (Month 0)",
"4) Month 144"
] |
NCT03753074 | 8.3 | Assessments for Premature Discontinuation from Study | 8.3 Assessments for Premature Discontinuation from Study If a subject in the Treatment Arm discontinues study drug, every attempt should be made to keep the subject taking study drug in the study and continue to perform the required studyrelated follow-up and procedures. If this is not possible or acceptable to the sub... | [
"Study Drug"
] |
NCT03753074 | 9.1 | Storage and Handling of the Study Drug | 9.1 Storage and Handling of the Study Drug TAF tablets should be stored at controlled room temperature of 25°C. Storage conditions are specified on the label. Until dispensed to the subjects, all bottles of study drugs should be stored in a securely locked area, accessible only to authorized site personnel. To ensure t... | [] |
NCT03753074 | 9.2 | Assessment of Adverse Effects | 9.2 Assessment of Adverse Effects The investigator or qualified sub-investigator is responsible for assessing the adverse effects using clinical judgment. The principal sources of safety for TAF consist of 2 Phase 3 studies in subjects with CHB, Study GS-US-320-0108 and GS-US-320-0110. Subjects included in the Safety A... | [] |
NCT03753074 | 9.3 | Concomitant Drugs | 9.3 Concomitant Drugs Concomitant medications taken at the time of screening, up to and including the date of the last study visit, need to be recorded in the source documents and eCRFs. | [] |
NCT03753074 | 9.4 | Drugs Prohibited | 9.4 Drugs Prohibited The antiviral agents which can affect the CHB treatment such as medications containing Tenofovir (Atripla, Complera and Truvada), Adefovir (Hepsera) and Entecavir (Baraclude) cannot be taken during the clinical trial. Precautionary and prohibited medications while treating with Vemlidy is listed in... | [
"Adverse Events"
] |
NCT03753074 | 10.1 | Definition of Adverse Events | 10.1 Definition of Adverse Events All adverse events will be assessed and recorded on the AE CRF page by the investigator. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation after randomization and which does not necessarily have a causal relationship with this treatment. An... | [] |
NCT03753074 | 10.2 | Assessment of AEs | 10.2 Assessment of AEs All AEs and SAEs occurring after randomization and until the end of follow-up/final visit should be recorded in the CRF. | [] |
NCT03753074 | 10.3 | Severe Adverse Events (SAEs) | 10.3 Severe Adverse Events (SAEs) A serious adverse event is any untoward medical occurrence after randomization: - Death or life-threatening events - Hospitalization or prolongation of existing hospitalization - Persistent or significant disability/incapacity - Development of fetal anomalies - Cases in which other med... | [] |
NCT03753074 | 10.4 | Reporting Procedures | 10.4 Reporting Procedures The principal investigator and sub-investigators have to notify IRB all SAEs during the study regardless of causal relationship. They must fax or e-mail the SAE form to Asan medical center within 48 hours of the investigator's acknowledgement of the event. All the information about serious adv... | [] |
NCT03753074 | 10.5 | Intensity of AE | 10.5 Intensity of AE | Grade | Description | |------------------|--------------------------------------------------------------------------------| | Mild | Asymptomatic or mild symptoms; clinical or diagnostic observations only; | | | intervention not indicated; no disruption of normal daily activity. | | Moderate | Mi... | [] |
NCT03753074 | 10.6 | Causal Relationship of AE | 10.6 Causal Relationship of AE The following categories and definitions of causal relationship to the study drug should be used for any AE:
1) Definitely related - Event or laboratory test abnormality, with plausible temporal relationship to the drug intake - Cannot be explained by the disease or other drugs - Respons... | [
"1) Definitely related",
"2) Probably related",
"3) Possibly related",
"4) Probably not related",
"5) Definitely not related",
"6) Unknown",
"Statistical Considerations"
] |
NCT03753074 | 11.1 | Sample Size Justification | 11.1 Sample Size Justification The primary outcome variable is the ratio of hazard rates based on the cumulative incidence of liver-related events, including death, liver transplantation, or decompensated liver diseases [Child-Pugh score≥7], complications of portal hypertension [ascites, gastroesophageal varices] or HC... | [] |
NCT03753074 | 11.2 | Statistical Analyses | 11.2 Statistical Analyses The primary analysis for assessing treatment efficacy and safety will be conducted using the Full Analysis Set, including all randomly assigned patients (Modified Intention-to-Treat analysis). Secondary analyses will involve on-treatment analysis, which includes patients participating in the s... | [
"Compliance and modification of the clinical trial protocol",
"Discontinuation and Withdrawal",
"Efficacy Evaluation"
] |
NCT03753074 | 14.1 | Primary endpoint | 14.1 Primary endpoint The primary efficacy endpoint of this study is the occurrence of composite events during followup observation including HCC, death, liver transplantation, or decompensated liver diseases (e.g., development of portal hypertensive complications including ascites, gastroesophageal varices, or Child-P... | [] |
NCT03753074 | 14.2 | Secondary endpoint | 14.2 Secondary endpoint - Cumulative proportion of subjects with undetectable HBV DNA - Cumulative proportion of subjects with on-treatment normal ALT - Cumulative incidence of composite clinical events (Composite endpoint: death, liver transplantation, decompensated cirrhosis [Child-Pugh score≥7], portal hypertension ... | [
"Safety Protection for the subjects",
"Informed Consent, Agreement of Compensation, Post-Study Treatment 16.1 Patient Information and Informed Consent"
] |
NCT03753074 | 16.2 | Compensation Available to the Patients in the Event of Trial Related Injury | 16.2 Compensation Available to the Patients in the Event of Trial Related Injury In the event of health injury associated with this trial, the sponsor is responsible for compensation based on the contract. | [] |
NCT03753074 | 16.3 | Treatment of the Subjects after the End of the Clinical Trial | 16.3 Treatment of the Subjects after the End of the Clinical Trial The subjects who have fulfilled the study would follow the standard treatment of CHB by current practice guidelines. The subjects who are terminated in the middle of the study should receive routine care corresponding patients with CHB.
Expected study ... | [
"Expected study results and development direction",
"Additional Ethical Considerations for the Study"
] |
NCT03753074 | 18.1 | Compliance and Modification of the Clinical Trial Protocol | 18.1 Compliance and Modification of the Clinical Trial Protocol This study must be conducted according to the clinical trial protocol, including written informed consent approved by the IRB. All protocol modifications should be upfront discussed between the investigators. All protocol modifications, except those intend... | [] |
NCT03753074 | 18.2 | Monitoring | 18.2 Monitoring Assigning the Clinical Research Associate (CRA) in charge of this trial, the CRA will regularly visit and monitor the study sites before starting the study and during the whole study period. The monitor is responsible for routine review of the CRFs at regular intervals throughout the study to verify adh... | [] |
NCT03753074 | 18.3 | Storage of the Documents and Data | 18.3 Storage of the Documents and Data The investigator must maintain all the documents and records of this study to be adequate and accurate and should subsequently verify them. The investigator is responsible for maintaining and providing of the essential documents. The essential documents mean ones that allow evalua... | [] |
NCT03753074 | 18.4 | Confidentiality of the Data and Records of the Subjects | 18.4 Confidentiality of the Data and Records of the Subjects The investigator must assure that subjects' anonymity will be strictly maintained. The subjects should be accessed by only subject initials or an identification code. Their identities have to be protected from unauthorized parties. Only the investigators, stu... | [] |
NCT03753074 | 18.5 | Provision of Personal Information to Third Parties and Secondary Use | 18.5 Provision of Personal Information to Third Parties and Secondary Use After the primary research is done, the follow-up secondary research is set to begin. For the secondary research, no new data needs to be collected. Therefore, the personal information given by the research subject can be used for statistical ana... | [
"Methods for Human Derived Material storage and disposal",
"References",
"Appendix 3. Internal Monitoring Committee (IMC) and Scientific Oversight Committee (SOC)"
] |
NCT03760146 | A | PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE–NAÏVE ADULTS 18 YEARS OF AGE AND OLDER | A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE–NAÏVE ADULTS 18 YEARS OF AGE AND OLDER Investigational Product Number: PF-06482077 Investigational Product Name: 20-valent Pneumococcal Conjugate Vaccine (20vPnC) Uni... | [
"Document History",
"TABLE OF CONTENTS",
"PROTOCOL SUMMARY",
"Background and Rationale",
"Study Design",
"Objectives and Endpoints",
"Primary Safety Objective (All Cohorts)",
"Primary Safety Endpoints (All Cohorts)",
"Primary Immunogenicity Objectives – Cohort 1 (60 Years of Age and Older)",
"Prim... |
NCT03761537 | 1 | Protocol synopsis | 1 Protocol synopsis | Trial IDEudraCT no.IND no.Title of trial | LP0162-13462018-000747-76123797administered in combination with topical corticosteroids | A randomised, double-blind, placebo-controlled, parallel-group, multi-centre,phase 3 trial investigating the efficacy, safety, and tolerability of tralokinumabto adu... | [
"Treatment period",
"Safety follow-up"
] |
NCT03761537 | 2 | Trial identification | 2 Trial identification EudraCT number: 2018-000747-76 IND number: 123797 The clinical trial protocol will be registered in local registries if required by local legislation. | [] |
NCT03761537 | 3 | Schematic of trial design | 3 Schematic of trial design Panel 1: Trial design  Abbreviations: AD: atopic dermatitis; No: number; TCI: topical calcineurin inhibitors; TCS: topical corticosteroids; Q2W: every other week; w: week.  Page 30 of 170
4Schedule of trial procedures Panel 2: Schedule of tria... | [
"4Schedule of trial procedures"
] |
NCT03761537 | 5 | Introduction and trial rationale | 5 Introduction and trial rationale | [] |
NCT03761537 | 5.1 | Atopic dermatitis | 5.1 Atopic dermatitis Atopic dermatitis (AD) is a chronic inflammatory skin disease that may affect up to 20% of children and up to 10% of adults. In its severe form, AD is characterised by widespread skin lesions, intractable itch, as well as increased susceptibility to bacterial, viral, and fungal skin infections (1-... | [] |
NCT03761537 | 5.2 | Experience with investigational medicinal product | 5.2 Experience with investigational medicinal product Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors (13–15). A compilation of clinical and nonclinical data on tralokinumab including pharmacokinetics (PK... | [] |
NCT03761537 | 5.3 | Trial rationale | 5.3 Trial rationale Section 5.6. Treatment recommendations for AD include topical therapies, the main being TCS. Unfortunately, TCS and topical calcineurin inhibitors (TCIs) have limited efficacy in patients with moderate-to-severe disease. TCS and non-biologic systemic therapies (e.g. CSA, azathioprine) are all associ... | [] |
NCT03761537 | 5.4 | Justification for dose | 5.4 Justification for dose The dose selected for the tralokinumab phase 3 development programme is 300 mg Q2W administered subcutaneously. All subjects randomised to treatment with tralokinumab will get an initial loading dose of 600 mg on Day 0 (baseline). The administration of the loading dose of tralokinumab will al... | [] |
NCT03761537 | 5.5 | Ethical considerations | 5.5 Ethical considerations No children or other vulnerable subjects incapable of giving informed consent will be enrolled in this clinical trial. Furthermore, women who are pregnant, breastfeeding, or trying to become pregnant will not be enrolled in this clinical trial. Women of child-bearing potential must agree to u... | [] |
NCT03761537 | 5.6 | Benefit/risk assessment | 5.6 Benefit/risk assessment Tralokinumab is a new biological therapy under investigation for the treatment of moderateto-severe AD in both the adult and paediatric age groups. Tralokinumab has already demonstrated efficacy in moderate-to-severe AD, and the evidence discussed in Section 5.2 further supports the hypothes... | [] |
NCT03761537 | 6 | Trial objectives and endpoints | 6 Trial objectives and endpoints Panel 4: Objectives and endpoints | Objectives | Endpoints | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03761537 | 7 | Trial design | 7 Trial design | [] |
NCT03761537 | 7.1 | Overall trial design | 7.1 Overall trial design
Overview This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre, phase 3 clinical trial in adult subjects with severe AD ineligible to treatment with CSA. The trial will consist of a screening period, a treatment period, and a safety follow-up period. The primary ... | [
"Overview",
"Screening period (Week -6 to Week 0)",
"Treatment period (Week 0 to Week 26)",
"Safety follow-up period (Week 26 to Week 40)",
"Long-term extension trial (selected countries)"
] |
NCT03761537 | 7.2 | Number of subjects needed | 7.2 Number of subjects needed Assuming a screening failure rate of 25%, approximately 333 subjects will be screened and approximately 250 subjects will be randomly assigned 1:1 to tralokinumab 300 mg+TCS or placebo+TCS. Randomisation will be handled using the interactive response technology (IRT) to ensure continued bl... | [] |
NCT03761537 | 7.3 | End of trial definition | 7.3 End of trial definition A subject is considered to have completed the trial if they have completed all periods of the trial including the final safety follow-up visit at Week 40. Subjects entering the long-term extension trial (LP0162-1337, ECZTEND) after completion of the end-of-treatment visit (Week 26) will also... | [] |
NCT03761537 | 7.4 | Software | 7.4 Software CDISC controlled terminology dated 30-Mar-2018 (or later) was used for definition of controlled terminology throughout this protocol and will be used for statistical programming and output. Study Data Tabulation Model (SDTM) version 1.4 (or newer) and SDTM implementation guide version 3.2 will be used for ... | [] |
NCT03761537 | 8 | Trial population | 8 Trial population | [] |
NCT03761537 | 8.1 | Subject eligibility | 8.1 Subject eligibility The investigator should only include subjects who meet all eligibility criteria, are not put at undue risk by participating in the trial, and can be expected to comply with the protocol. The subject's eligibility for the clinical trial must be verified according to the inclusion and exclusion cr... | [] |
NCT03761537 | 8.2 | Inclusion criteria | 8.2 Inclusion criteria For inclusion into this trial, subjects must fulfil all of the following criteria: - 1. Signed and dated informed consent has been obtained prior to any protocol-related procedures. - 2. Age 18 and above. - 3. Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD (21; Appendi... | [] |
NCT03761537 | 8.3 | Exclusion criteria | 8.3 Exclusion criteria Subjects must not enter the trial if any of the following exclusion criteria are fulfilled: - 1. Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks (including intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic ... | [] |
NCT03761537 | 8.4 | Screening and screening failures | 8.4 Screening and screening failures
Subject identification number Trial participation begins once written informed consent is obtained. Refer to Appendix 3B for details on the informed consent process. Once informed consent is obtained, a subject identification number (subject ID) will be assigned by a central IRT sy... | [
"Subject identification number",
"Screening failures"
] |
NCT03761537 | 9 | Treatments | 9 Treatments | [] |
NCT03761537 | 9.1 | Trial product description | 9.1 Trial product description | [] |
NCT03761537 | 9.1.1 | Investigational medicinal product (IMP) | 9.1.1 Investigational medicinal product (IMP) Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for SC administration. Tralokinumab and placebo will be packaged in i... | [] |
NCT03761537 | 9.1.2 | Auxiliary medicinal product (AxMP) | 9.1.2 Auxiliary medicinal product (AxMP) Each subject will be prescribed an auxiliary medicinal product (AxMP): the subjects will receive a TCS cream (Europe: Class 3 [potent]) from randomisation (Week 0) to Week 26. This will be provided as mometasone furoate, 0.1% cream in kit sizes of 180–225 g every 2 weeks. This s... | [] |
NCT03761537 | 9.2 | Administration of trial products | 9.2 Administration of trial products | [] |
NCT03761537 | 9.2.1 | Administration of IMP | 9.2.1 Administration of IMP The IRT will assign the required kit numbers for each subject at each dispensing visit. Dosing visits are shown in the schedule of trial procedures (Section 4). The last administration of IMP will occur at Week 24. To ensure blinding, both treatment groups will receive the same number of inj... | [
"After IMP administration",
"Conditions requiring rescheduling of IMP administration"
] |
NCT03761537 | 9.2.2 | Administration of AxMP | 9.2.2 Administration of AxMP The IRT will assign the required AxMP (TCS) kit numbers for each subject at each dispensing visit. The TCS will be provided as mometasone furoate, 0.1% cream in kit sizes of 180–225 g Q2W. If needed, additional TCS kit(s) may be dispensed to the subject at a scheduled or unscheduled visit a... | [] |
NCT03761537 | 9.3 | Treatment assignment | 9.3 Treatment assignment
Randomisation Subjects who have been found to comply with all the inclusion criteria and not to violate any of the exclusion criteria will be randomised centrally at baseline (Day 0) to receive treatment with either tralokinumab 300 mg+TCS or placebo+TCS, stratified by prior CSA use (yes/no), ... | [
"Randomisation"
] |
NCT03761537 | 9.3.1 | Blinding | 9.3.1 Blinding This is a double-blinded trial in which tralokinumab and placebo are visually distinct from each other. Neither the subject, nor the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and... | [] |
NCT03761537 | 9.3.2 | Emergency unblinding of individual subject treatment | 9.3.2 Emergency unblinding of individual subject treatment While the safety of a subject always comes first, it is still important to carefully consider if unblinding is necessary to ensure a subject's safety. An emergency unblinding request can be made by the investigators, HCPs who are not members of the trial staff,... | [] |
NCT03761537 | 9.4 | Background treatment | 9.4 Background treatment All subjects must use an emollient twice daily (or more, as needed) for at least 14 days before randomisation; the background treatment should preferably be an additive free, basic bland emollient. Subjects must continue their background emollient treatment throughout the trial. , rescue treatment for AD may be provided to trial subjects at the discretion of the investigator. If possible, investigators should attempt to limit the first step of rescue therapy to topical medications (i.e. higher potency TCS, Eu... | [] |
NCT03761537 | 9.6 | Concomitant medication and concurrent procedures | 9.6 Concomitant medication and concurrent procedures Any medication or vaccine that the subject receives from 3 months prior to screening through safety follow-up (Week 40) must be recorded in the subject's medical record and the eCRF along with details such as: - x Medication name. - x Indication. - x Start and stop d... | [] |
NCT03761537 | 9.7 | Prohibited medication and procedures | 9.7 Prohibited medication and procedures The medications listed below are prohibited during the trial from randomisation. Medications and procedures disallowed prior to randomisation are covered in the exclusion criteria (see Section 8.3). In case any prohibited treatments are used during the trial, they must be record... | [] |
NCT03761537 | 9.8 | Treatment logistics and accountability | 9.8 Treatment logistics and accountability | [] |
NCT03761537 | 9.8.1 | Labelling and packaging of trial products | 9.8.1 Labelling and packaging of trial products
Investigational medicinal product The IMP will be packaged in individually numbered kits, each containing 1 syringe (tralokinumab 150 mg or placebo). Primary and secondary packaging materials (syringe and outer carton, respectively) will be individually labelled. The lab... | [
"Investigational medicinal product",
"Auxiliary medicinal product"
] |
NCT03761537 | 9.8.2 | Storage of trial products | 9.8.2 Storage of trial products
Storage of IMP All LEO supplied IMPs must be stored in a secure and restricted area under the conditions specified on the label and remain in the original container until dispensed. The IMP must be stored at 2-8°C at the trial site. The temperature during storage should be monitored by ... | [
"Storage of IMP",
"Storage of AxMP"
] |
NCT03761537 | 9.8.3 | Drug accountability | 9.8.3 Drug accountability Trial product accountability will be performed in the IRT.
IMP accountability The investigator is fully responsible for the IMPs at the trial site and for maintaining adequate control of the IMPs and for documenting all transactions with them. Dispensing of IMPs may be delegated, e.g., to a h... | [
"IMP accountability",
"AxMP accountability",
"Reporting in eCRF"
] |
NCT03761537 | 9.8.4 | Treatment compliance | 9.8.4 Treatment compliance IMP injections will be performed by site staff that will also hand out TCS for selfadministration and keep the accountability records up to date. Any non-compliance with IMP administration and dispensing and return of TCS and the reason for it must be recorded in the eCRF. | [] |
NCT03761537 | 9.8.5 | Trial product destruction | 9.8.5 Trial product destruction Please refer to the trial product handling manual regarding details for trial product destruction. | [] |
NCT03761537 | 9.9 | Provision for subject care following trial completion | 9.9 Provision for subject care following trial completion In order to ensure appropriate treatment of the subjects after they have completed the trial, the subjects will be treated at the investigator's discretion or referred to other physician(s) according to standard practice. Subjects who qualify for the long-term e... | [] |
NCT03761537 | 9.10 | Reporting product complaints | 9.10 Reporting product complaints Any defects or issues with the IMP, AxMP (TCS) as well as any IMP device deficiency (including malfunctions, use errors, and inadequate labelling) must be reported to Global Safety at LEO on the trial-specific (paper) Complaint Form within 3 days of first knowledge. Critical complaints... | [] |
NCT03761537 | 10 | Discontinuation and withdrawal | 10 Discontinuation and withdrawal | [] |
NCT03761537 | 10 | 1General principles | 10.1General principles A subject may permanently discontinue trial treatment (IMP) or withdraw from the trial at any time (prior to first dose or during the treatment period) if the subject, the investigator, or LEO considers that it is not in the subject's best interest to continue. In order to obtain the most represe... | [] |
NCT03761537 | 10.2 | IMP discontinuation rules | 10.2 IMP discontinuation rules | [] |
NCT03761537 | 10.2.1 | Reasons for permanent discontinuation of IMP | 10.2.1 Reasons for permanent discontinuation of IMP Subjects will permanently discontinue IMP in the event of: - x Anaphylactic reaction or other severe systemic reaction to IMP injection. - x An AE that, in the opinion of the investigator or sponsor's medical expert, contraindicates further dosing. - x Diagnosis of a ... | [] |
NCT03761537 | 10.2.2 | Reasons for temporary discontinuation of IMP | 10.2.2 Reasons for temporary discontinuation of IMP IMP dosing may be temporarily suspended in the event of: - x Other intercurrent illnesses or major surgery. - x An infection that requires parenteral treatment with antibiotic, antifungal, antiviral, antiparasitic, or anti-protozoal agents. - x Treatment with systemic... | [] |
NCT03761537 | 10 | 3Early termination assessments | 10.3Early termination assessments
Permanent discontinuation of IMP Subjects who permanently discontinue IMP for any reason will be asked to attend additional visits as indicated below (Panel 6). See the schedule of trial procedures for data to be collected at these visits (Section 4). The investigator will review any ... | [
"Permanent discontinuation of IMP",
"Withdrawal from trial",
"Data to be recorded in the eCRF and medical records"
] |
NCT03761537 | 10 | 4Lost to follow-up | 10.4Lost to follow-up A subject will be considered lost to follow-up if they repeatedly fail to return for scheduled visits and if the trial site is not able to get in contact with the subject. The following actions must be taken if a subject fails to return to the trial site for a required visit: - x The trial site mu... | [] |
NCT03761537 | 11 | Trial assessments and procedures | 11 Trial assessments and procedures | [] |
NCT03761537 | 11 | 1Overview | 11.1Overview During the trial there are 17 scheduled site visits at the clinic. Evaluations to be done at each visit are shown in the schedule of trial procedures in Section 4: - x Panel 2 includes the assessments during screening and treatment. - x Panel 3 includes the assessments during follow-up (including early ter... | [] |
NCT03761537 | 11.2 | Assessments performed only at screening/baseline | 11.2 Assessments performed only at screening/baseline | [] |
NCT03761537 | 11.2.1 | Demographics | 11.2.1 Demographics The following demographic data will be recorded: - x Age: date of birth (or only year and month of birth as applicable according to local legislation). - x Sex: female; male. - x Race: American Indian or Alaska native; Asian; black or African American; native Hawaiian or other Pacific islander; whit... | [] |
NCT03761537 | 11.2.2 | Medical history | 11.2.2 Medical history Relevant past and concurrent medical history must be recorded: - x Skin disease history. All past and current skin disease history including but not limited to: - o Alopecia - o Vitiligo - o Herpes simplex infection  Page 72 of 170 - x Atopy history - o Duration of AD in ... | [] |
NCT03761537 | 11.2.3 | Height and weight | 11.2.3 Height and weight The subject's height (without shoes) will be measured; the subject's weight (in indoor clothing and without shoes) will be measured. | [] |
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