protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04867785 | 8.4 | Treatment of Overdose | 8.4. Treatment of Overdose For this study, any total dose of study intervention within a 48-hour time period greater than the dose assigned by IWRS for that participant will be considered an overdose and should be reported as per criteria described in Section [10.3.](#page-82-0) In the event of an overdose, the investi... | [] |
NCT04867785 | 8.5 | Pharmacokinetics | 8.5. Pharmacokinetics Blood samples for PK analyses will be collected from all randomized participants in accordance with schedule provided in Section [1.3](#page-11-0) and at ED. Efforts should be taken to align clinical visits with PK sampling windows specified in the Pharmacokinetic Schedule of Events table (Section... | [] |
NCT04867785 | 8.5.1 | Bioanalysis | 8.5.1. Bioanalysis Samples will be analyzed at a laboratory approved by the sponsor and stored at a facility designated by the sponsor. Concentrations of LY3437943 will be assayed using a validated liquid chromatography mass spectrometry method. Analyses of samples collected from participants who received placebo or du... | [] |
NCT04867785 | 8.6 | Pharmacodynamics | 8.6. Pharmacodynamics Pharmacodynamic assessments for LY3437943 are included as part of the efficacy and safety measures listed in Section [8.1](#page-49-1) and will be collected according to the SoA (Section [1.3\)](#page-11-0). | [] |
NCT04867785 | 8.7 | Genetics | 8.7. Genetics A blood sample will be collected to enable exploratory pharmacogenetic analyses as specified in the SoA (Section [1.3\)](#page-11-0), where local regulations allow. Samples will not be used to conduct unspecified disease or population genetic research either now or in the future. Samples may be used to in... | [] |
NCT04867785 | 8.8 | Biomarkers | 8.8. Biomarkers In addition to the planned biomarker research as indicated in the SoA and Section [10.11,](#page-106-0) biomarker research on stored nonpharmacogenetic samples may be performed to address questions of relevance to drug disposition, target engagement, pharmacodynamics, mechanism of action, variability of... | [] |
NCT04867785 | 8.9 | Immunogenicity Assessments | 8.9. Immunogenicity Assessments At the visits and times specified in the SoA (Section [1.3\)](#page-11-0), blood samples will be collected to determine antibody production against LY3437943. Antibodies may be further characterized for cross-reactive binding to endogenous counterparts (native GIP, GLP-1, and glucagon), ... | [] |
NCT04867785 | 8.10 | Health Economics | 8.10. Health Economics This section is not applicable for this study. | [] |
NCT04867785 | 9 | Statistical Considerations | 9. Statistical Considerations | [] |
NCT04867785 | 9.1 | Statistical Hypotheses | 9.1. Statistical Hypotheses The primary hypothesis that is being tested in this study is that LY3437943 0.5, 4, 8, or 12 mg administered SC QW is superior to placebo with regards to change in HbA1c from baseline to Week 24, in participants with T2D inadequately controlled with diet and exercise with or without a stable... | [] |
NCT04867785 | 9.2 | Sample Size Determination | 9.2. Sample Size Determination Approximately 300 participants will be randomized in a 2:2:2:1:1:1:1:2 ratio to either placebo, dulaglutide 1.5 mg, LY3437943 0.5 mg, LY3437943 4 mg (with starting dose at 2 mg), LY3437943 4 mg (with starting dose at 4 mg), LY3437943 8 mg (with starting dose at 2 mg), LY3437943 8 mg (with... | [] |
NCT04867785 | 9.3 | Populations for Analyses | 9.3. Populations for Analyses The following populations are defined for the purpose of analysis: | Population | Description | |-----------------------------|--------------------------------------------------------------------------------| | Screened | All participants who have signed informed consent. | | Randomized | ... | [] |
NCT04867785 | 9.4 | Statistical Analyses | 9.4. Statistical Analyses | [] |
NCT04867785 | 9.4.1 | General Considerations | 9.4.1. General Considerations Statistical analyses of this study will be the responsibility of Lilly or its designee. Any change to the data analyses methods described in the protocol will require an amendment ONLY if it changes a principal feature of the protocol. Any other change to data analyses methods described in... | [] |
NCT04867785 | 9.4.2 | Treatment Group Comparability | 9.4.2. Treatment Group Comparability | [] |
NCT04867785 | 9.4.2.1 | Participant Disposition | 9.4.2.1. Participant Disposition Frequency counts and percentages of all participants screened, randomized, and receiving at least 1 dose of study drug will be presented by treatment groups. A listing of randomized participants not receiving study drug will be provided. All participants who discontinue the study will b... | [] |
NCT04867785 | 9.4.2.2 | Participant Characteristics | 9.4.2.2. Participant Characteristics Demographics, medical history, and concomitant illness will be summarized by treatment group using the full FAS. | [] |
NCT04867785 | 9.4.2.3 | Concomitant Therapy | 9.4.2.3. Concomitant Therapy Concomitant medications, including previous therapy for diabetes, will be summarized by drug class and treatment group using the FAS. In particular, the incidence of rescue therapy for severe, persistent hyperglycemia will be analyzed as an exploratory safety endpoint. | [] |
NCT04867785 | 9.4.2.4 | Treatment Compliance | 9.4.2.4. Treatment Compliance Treatment compliance for each 4- to 6-week interval is defined as taking at least 75% of the required SC doses of study drug. Frequency counts and percentages of participants compliant to study drug will be summarized by treatment arm using the FAS. | [] |
NCT04867785 | 9.4.3 | Efficacy Analyses | 9.4.3. Efficacy Analyses | [] |
NCT04867785 | 9.4.3.1 | Primary Analyses | 9.4.3.1. Primary Analyses The primary efficacy analyses will be conducted to establish superiority of LY3437943 0.5 mg, LY3437943 4 mg, LY3437943 8 mg, or LY3437943 12 mg to placebo with regards to change in HbA1c from baseline to 24 weeks. The primary analyses will be performed on EAS using MMRM with treatment, visit,... | [] |
NCT04867785 | 9.4.3.2 | Secondary Analyses | 9.4.3.2. Secondary Analyses In addition to the primary efficacy analysis of change in HbA1c in study population, the following secondary study objectives will be analyzed on the EAS: - change in HbA1c from baseline to 24 and 36 weeks - percentage of participants reaching HbA1c of <7.0% at 24 and/or 36 weeks - change in... | [] |
NCT04867785 | 9.4.3.3 | Tertiary/Exploratory Analyses | 9.4.3.3. Tertiary/Exploratory Analyses A Bayesian approach will be used as the dose–response model for change in HbA1c and body weight from baseline to the 24-week endpoint. The placebo group will be modeled with LY3437943 doses. Details of the prior distribution specifications along with other analyses with regards to... | [] |
NCT04867785 | 9.4.4 | Safety Analyses | 9.4.4. Safety Analyses Unless specified otherwise, safety assessments will be guided by an estimand comparing safety of LY3437943 doses with placebo irrespective of adherence to study drug or initiation of rescue therapy. Thus, safety analyses will be conducted using the FAS. Selected safety analyses may be conducted a... | [] |
NCT04867785 | 9.4.4.1 | Hypoglycemia Events | 9.4.4.1. Hypoglycemia Events Hypoglycemic events will be analyzed. Incidence and rate of hypoglycemia will be reported. Some analyses may be conducted excluding data after introducing another antihyperglycemic therapy. | [] |
NCT04867785 | 9.4.4.2 | Gastrointestinal Events | 9.4.4.2. Gastrointestinal Events Summaries and analyses for incidence and severity of nausea, vomiting, and diarrhea will be provided by each treatment. | [] |
NCT04867785 | 9.4.4.3 | Central Laboratory Measures, Vital Signs, and Electrocardiograms | 9.4.4.3. Central Laboratory Measures, Vital Signs, and Electrocardiograms Values and change from baseline to postbaseline values of central laboratory measures, vital signs, and selected ECG parameters will be summarized at each scheduled visit. The analysis model to make comparisons among treatment groups relative to ... | [] |
NCT04867785 | 9.4.5 | Pharmacokinetic/Pharmacodynamic Analyses | 9.4.5. Pharmacokinetic/Pharmacodynamic Analyses LY3437943 concentration data will be summarized and analyzed using a population PK approach via nonlinear mixed-effects modeling. The relationships between LY3437943 dose and/or concentration and selected efficacy, tolerability, and safety endpoints may be characterized. ... | [] |
NCT04867785 | 9.4.6 | Evaluation of Immunogenicity | 9.4.6. Evaluation of Immunogenicity The frequency and percentage of participants with preexisting ADA and with treatmentemergent ADA+ to LY3437943 may be tabulated. Treatment-emergent ADAs are defined as those with a titer 2-fold (1 dilution) greater than the minimum required dilution if no ADAs were detected at baseli... | [] |
NCT04867785 | 9.4.7 | Subgroup Analyses | 9.4.7. Subgroup Analyses Subgroup analyses of important factors, including baseline BMI, baseline HbA1c, and other factors to be specified in the SAP, are planned for the key outcomes. The models used for these analyses will vary depending on the subgroups and the outcome. More details of the modeling will be provided ... | [] |
NCT04867785 | 9.5 | Interim Analyses | 9.5. Interim Analyses An interim efficacy and safety assessment after all participants complete Visit 9 (Week 16) of the treatment period will be conducted to provide initial guidance for the design of future clinical studies of LY3437943. An internal AC will be formed to review the interim analyses for the safety and ... | [] |
NCT04867785 | 9.6 | Data Monitoring Committee (DMC) | 9.6. Data Monitoring Committee (DMC) Not applicable. | [] |
NCT04867785 | 10 | Supporting Documentation and Operational Considerations | 10. Supporting Documentation and Operational Considerations | [] |
NCT04867785 | 10.1 | Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | 10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | [] |
NCT04867785 | 10.1.1 | Regulatory and Ethical Considerations | 10.1.1. Regulatory and Ethical Considerations - This study will be conducted in accordance with the protocol and with the following: - consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) Internat... | [] |
NCT04867785 | 10.1.2 | Informed Consent Process | 10.1.2. Informed Consent Process ● The investigator or his or her representative will explain the nature of the study, including the risks and benefits, to the participant or his or her legally authorized representative and answer all questions regarding the study. - Participants must be informed that their participati... | [] |
NCT04867785 | 10.1.3 | Data Protection | 10.1.3. Data Protection - Participants will be assigned a unique identifier by the sponsor. Any participant records, datasets, or tissue samples that are transferred to the sponsor will contain the identifier only; participant names or any information which would make the participant identifiable will not be transferre... | [] |
NCT04867785 | 10.1.4 | Committees Structure | 10.1.4. Committees Structure An independent CEC will be formed to adjudicate major adverse cardiovascular events, deaths, and pancreatitis AEs. Sections [8.3.2.3](#page-58-1) and [8.3.2.5](#page-60-0) outline additional information on pancreatic and cardiovascular adjudication committees, respectively. An internal AC w... | [] |
NCT04867785 | 10.1.5 | Dissemination of Clinical Study Data | 10.1.5. Dissemination of Clinical Study Data Required clinical trial registries (for example, ClinicalTrials.gov) will be updated with the results from registered clinical trials regardless of the research outcome in accordance with local laws and regulations. All CSRs, amendments, and addenda will be submitted to exte... | [] |
NCT04867785 | 10.1.6 | Data Quality Assurance | 10.1.6. Data Quality Assurance - All participant data relating to the study will be recorded on printed or electronic CRF unless transmitted to the sponsor or designee electronically (for example, laboratory data). The investigator is responsible for verifying that data entries are accurate and correct by physically or... | [
"Data Capture System"
] |
NCT04867785 | 10.1.7 | Source Documents | 10.1.7. Source Documents - Source documents provide evidence for the existence of the participant and substantiate the integrity of the data collected. Source documents are filed at the investigator's site. - Data reported on the CRF or entered in the eCRF that are transcribed from source documents must be consistent w... | [] |
NCT04867785 | 10.1.8 | Study and Site Start and Closure | 10.1.8. Study and Site Start and Closure | [] |
NCT04867785 | 10.1.8.1 | Discontinuation of the Study | 10.1.8.1. Discontinuation of the Study The sponsor designee reserves the right to terminate the study at any time for any reason at the sole discretion of the sponsor. The study will be discontinued if Lilly or its designee judges it necessary for medical, safety, regulatory, or other reasons consistent with applicable... | [
"Medical Oversight and Safety Review"
] |
NCT04867785 | 10.1.8.2 | Discontinuation of Study Sites | 10.1.8.2. Discontinuation of Study Sites The sponsor designee reserves the right to close the study site at any time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study completion. A study site is considered closed when all required documents and study supplies have been collecte... | [] |
NCT04867785 | 10.1.9 | Publication Policy | 10.1.9. Publication Policy In accordance with the sponsor's publication policy, the results of this study will be submitted for publication by a peer-reviewed journal. | [] |
NCT04867785 | 10.1.10 | Investigator Information | 10.1.10. Investigator Information Physicians with experience in Phase II or Phase III diabetes clinical trials will participate as investigators in this clinical trial. | [] |
NCT04867785 | 10.2 | Appendix 2: Clinical Laboratory Tests | 10.2. Appendix 2: Clinical Laboratory Tests - The tests detailed below will be performed by the central laboratory. - Local laboratory results are only required in the event that the central laboratory results are not available in time for either study intervention administration and/or response evaluation. If a local ... | [] |
NCT04867785 | 10.3 | Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting | 10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting - The definitions and procedures detailed in this appendix are in accordance with International Organization for Standardization (ISO) 14155. - Both the investigator and the sponsor will comply with all loca... | [] |
NCT04867785 | 10.3.1 | Definition of AE | 10.3.1. Definition of AE
AE Definition - An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory fi... | [
"AE Definition",
"Events Meeting the AE Definition",
"Events NOT Meeting the AE Definition"
] |
NCT04867785 | 10.3.2 | Definition of SAE | 10.3.2. Definition of SAE If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions are met (for example, hospitalization for signs or symptoms of the disease under study, death due to progression of disease). An SAE that can be attributed to a medical device or device constitue... | [
"SAE is defined as any untoward medical occurrence that, at any dose:",
"Results in death",
"Is life-threatening",
"Requires inpatient hospitalization or prolongation of existing hospitalization",
"Results in persistent disability or incapacity",
"Is a congenital anomaly or birth defect",
"Other situati... |
NCT04867785 | 10.3.3 | Definition of Product Complaints | 10.3.3. Definition of Product Complaints
Product Complaint A PC is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a study intervention. When the ability to use the study intervention safely is ... | [
"Product Complaint"
] |
NCT04867785 | 10.3.4 | Recording and Follow-Up of AE and/or SAE and Product Complaints | 10.3.4. Recording and Follow-Up of AE and/or SAE and Product Complaints
AE, SAE, and PC Recording - When an AE/SAE/PC occurs, it is the responsibility of the investigator to review all documentation (for example, hospital progress notes, laboratory reports, and diagnostics reports) related to the event. - The investig... | [
"AE, SAE, and PC Recording",
"Assessment of Intensity",
"Assessment of Causality",
"Follow-Up of AEs and SAEs"
] |
NCT04867785 | 10.3.5 | Reporting of SAEs | 10.3.5. Reporting of SAEs
SAE Reporting via an Electronic Data Collection Tool - The primary mechanism for reporting an SAE will be the electronic data collection tool. - If the electronic system is unavailable, then the site will use the paper SAE data collection tool (see next section) in order to report the event w... | [
"SAE Reporting via an Electronic Data Collection Tool",
"SAE Reporting via Paper CRF"
] |
NCT04867785 | 10.3.6 | Regulatory Reporting Requirements | 10.3.6. Regulatory Reporting Requirements
SAE Regulatory Reporting - Prompt notification by the investigator to the sponsor of a SAE is essential so that legal obligations and ethical responsibilities towards the safety of participants and the safety of a study intervention under clinical investigation are met. - The ... | [
"SAE Regulatory Reporting"
] |
NCT04867785 | 10.4 | Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information | 10.4. Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information Women of childbearing potential (WOCBP) and women not of childbearing potential (WNOCBP) may participate in this trial. WOCBP need to either remain abstinent (if this is their usual preferred lifestyle) or if they are in a same-sex relatio... | [
"Males",
"Examples of highly effective, effective, and unacceptable methods of contraception can be found below.",
"Collection of Pregnancy Information",
"Male participants with partners who become pregnant",
"Female participants who become pregnant"
] |
NCT04867785 | 10.5 | Appendix 5: Liver Safety: Suggested Actions and Follow-Up Assessments | 10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-Up Assessments For testing selected, analysis is required to be completed by the Lilly-designated central laboratory, except for microbiology. Local testing may be performed in addition to central testing when required for immediate participant management. Re... | [] |
NCT04867785 | 10.6 | Appendix 6: Genetics | 10.6. Appendix 6: Genetics
Use/Analysis of DNA ● Genetic variation may impact a participant's response to study intervention, susceptibility to, and severity and progression of disease. Variable response to study intervention may be due to genetic determinants that impact drug absorption, distribution, metabolism, and... | [
"Use/Analysis of DNA"
] |
NCT04867785 | 10.7 | Appendix 7: World Health Organization Classification of Diabetes and Diagnostic Criteria | 10.7. Appendix 7: World Health Organization Classification of Diabetes and Diagnostic Criteria Type 1 Diabetes: Type 1 diabetes is judged to be present when the classical symptoms of diabetes (thirst, polyuria, wasting and stupor, or coma) are associated with readily detectable concentrations of glucose and ketone bodi... | [] |
NCT04867785 | 10.8 | Appendix 8: New York Heart Association Functional Classification IV CHF | 10.8. Appendix 8: New York Heart Association Functional Classification IV CHF New York Heart Association (NYHA) classification NYHA grading MET\ Class I No limitations. Ordinary physical activity does not cause undue fatigue, dyspnea, or palpitations (asymptomatic LV dysfunction). >7 Class II Slight limitation of physi... | [] |
NCT04867785 | 10.9 | Appendix 9: Protocol GZBD Standardized Protocols for the Measurement of Height, Weight, Waist Circumference, Vital Signs, ECG, SMBG and MNSI | 10.9. Appendix 9: Protocol GZBD Standardized Protocols for the Measurement of Height, Weight, Waist Circumference, Vital Signs, ECG, SMBG and MNSI The following information has been adapted from standardized physical measurement protocols for the World Health Organization's STEPwise approach to Surveillance (STEPS) (WH... | [
"Measuring Height",
"Measuring Weight",
"Measuring Waist Circumference",
"Vital Sign Measurements",
"Orthostatic Vital Sign Measurements",
"Electrocardiogram",
"Self-Monitoring of Blood Glucose"
] |
NCT04867785 | 10.10 | Appendix 10: Patient-Reported Outcomes | 10.10. Appendix 10: Patient-Reported Outcomes When feasible, the self-administered questionnaires will be translated into the native language of the participant, linguistically validated and administered according to the SoA (Section [1.3\)](#page-11-0). The language of the signed ICF will be considered the native lang... | [
"Short Form-36 version 2 Health Survey acute form, 1-week recall version",
"Eating Inventory",
"Appetite Visual Analog Scale"
] |
NCT04867785 | 10.11 | Appendix 11: Metabolic Mechanistic Biomarkers | 10.11. Appendix 11: Metabolic Mechanistic Biomarkers Mechanistic biomarkers will be measured at longitudinal intervals (longitudinal biomarkers) or less frequently to correspond with interim analysis, primary and secondary endpoints (endpoint biomarkers). Results will not be provided to the investigative sites. To expl... | [
"CCI"
] |
NCT04867785 | 10.12 | Appendix 12: Provisions for Changes in Study Conduct during Exceptional Circumstances | 10.12. Appendix 12: Provisions for Changes in Study Conduct during Exceptional Circumstances
Implementation of this appendix The changes to procedures described in this appendix are temporary measures intended to be used only during specific time periods as directed by the sponsor in partnership with the investigator.... | [
"Implementation of this appendix",
"Exceptional circumstances",
"Implementing changes under exceptional circumstances",
"Considerations for making a change",
"Informed consent",
"Changes in study conduct during exceptional circumstances",
"Remote visits",
"Types of remote visits",
"Telemedicine:",
... |
NCT04867785 | 10.13 | Appendix 13: Abbreviations | 10.13. Appendix 13: Abbreviations Term Definition AC assessment committee ADA anti-drug antibodies AE adverse event: any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse e... | [] |
NCT04867785 | 10.14 | Appendix 14: Protocol Amendment History | 10.14. Appendix 14: Protocol Amendment History The Protocol Amendment Summary of Changes Table for the current amendment is located directly before the Table of Contents (TOC). Amendment b: 10-May-2021
Overall Rationale for the Amendment: The overall changes and rationale for the changes made to this protocol are desc... | [
"Overall Rationale for the Amendment:",
"Overall Rationale for the Amendment:"
] |
NCT04867785 | 11 | References | 11. References [ADA] American Diabetes Association. 6. Glycemic targets: standards of medical care in diabetes-2020. Diabetes Care. 2020;43(suppl 1):S66-S76. https://doi.org/10.2337/dc20-S006 Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis an... | [
"Signature Page for VV-CLIN-072318 v1.0"
] |
NCT05014568 | 1.1 | Background Information and Study Rationale 1.1.1 Background Information | 1.1 Background Information and Study Rationale 1.1.1 Background Information Atopic dermatitis (AD) (also called atopic eczema) is an intensely pruritic, chronic, relapsing, inflammatory skin disease [' , 2008]. The characteristic signs and symptoms of AD include sensations of pruritis and burning, xerosis, erythematous... | [] |
NCT05014568 | 1.1.2 | Study Rationale | 1.1.2 Study Rationale This pivotal Phase 3 study is being conducted as part of a clinical development program to evaluate the efficacy and safety of tapinarof cream, 1% for the topical treatment of AD in adults and children ages 2 years and above. The results of this study are intended to support product registration i... | [] |
NCT05014568 | 1.2 | Rationale for Study Design, Dose, and Control Groups | 1.2 Rationale for Study Design, Dose, and Control Groups This study is an 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream QD for 8 weeks. The study will be conducted at multiple study sites in more than one country to enhance t... | [] |
NCT05014568 | 1.3 | Potential Risks and Benefits | 1.3 Potential Risks and Benefits To assess any potential impact on subject eligibility with regard to safety, the Investigator must refer to the current version of the tapinarof Investigator's Brochure for detailed information regarding warnings, precautions, contraindications, AEs, and other significant data pertainin... | [] |
NCT05014568 | 1.3.2 | Benefit Assessment | 1.3.2 Benefit Assessment Subjects may experience improvements in their AD during the course of the study and may benefit from the additional safety assessments conducted as part of the study (e.g., physical examination, laboratory tests). Subjects in the study will also contribute to the process of developing a novel a... | [] |
NCT05014568 | 1.3.3 | Overall Benefit Risk | 1.3.3 Overall Benefit Risk Taking into account the measures taken to minimize risk to subjects in this study, the potential risks identified in association with tapinarof are justified by the anticipated benefits that may be afforded to subjects with AD. | [] |
NCT05014568 | 2 | Objectives and Endpoints | 2 Objectives and Endpoints The objectives and associated endpoints of the study are as follows: | Objectives | Associated Endpoint | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------... | [] |
NCT05014568 | 3 | Study Design | 3 Study Design | [] |
NCT05014568 | 3.1 | Overall Design | 3.1 Overall Design This is a double-blind, randomized, vehicle-controlled, Phase 3, multicenter study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared with vehicle cream in children and adult subjects with AD. Following a 30-day screening period, eligible subjects will be randomized at a 2:1 ... | [] |
NCT05014568 | 3.2 | Treatment Groups and Duration | 3.2 Treatment Groups and Duration This 8-week, Phase 3 study is a double-blind, vehicle-controlled treatment study in which subjects will be randomized in a 2:1 ratio to receive QD treatment with either tapinarof cream, 1% or matching vehicle cream. | [] |
NCT05014568 | 3.3 | Definition of Study Completion and Eligibility for Open-Label, Long-Term Extension Study | 3.3 Definition of Study Completion and Eligibility for Open-Label, Long-Term Extension Study In order to complete the study, a subject must complete 8 weeks of study assessments. To be considered a "study completer" in terms of treatment period, a subject must complete >80.0% of the intended doses. The number of intend... | [] |
NCT05014568 | 4 | Study Population | 4 Study Population | [] |
NCT05014568 | 4.1 | Type and Number of Subjects | 4.1 Type and Number of Subjects Approximately 400 adult and pediatric subjects ages 2 years and above with AD will be enrolled in the study at approximately 60 study sites in the US and Canada. A minimum of approximately 15% of subjects will be enrolled into each of the following age groups: 2-6 years, 7-11 years, 12-1... | [] |
NCT05014568 | 4.2 | Inclusion Criteria | 4.2 Inclusion Criteria Each subject must meet all of the following criteria to be eligible to participate in the study: - 1. Male and female subjects ages 2 years and above with clinical diagnosis of AD by Hanifin and Rajka criteria [Hanifin, 1980] (see Appendix 1). - 2. Subjects with AD covering ≥ 5% and ≤ 35% of the ... | [] |
NCT05014568 | 4.3 | Exclusion Criteria | 4.3 Exclusion Criteria A subject who meets any of the following criteria will be excluded and considered ineligible for participation in the study:
1. Concurrent conditions: - a. Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome) or history or evidence of active or latent tuberculosis or human immu... | [
"1. Concurrent conditions:"
] |
NCT05014568 | 4.4 | Lifestyle Restrictions | 4.4 Lifestyle Restrictions Subjects must avoid ultraviolet light, phototherapy, and excessive sun exposure throughout the study. When prolonged exposure cannot be avoided, use of sunscreen products (except on AD lesions) and protective apparel are recommended. | [] |
NCT05014568 | 4.5 | Screening/Baseline Failures | 4.5 Screening/Baseline Failures To determine subject eligibility at Screening and Baseline, a single repeat of tests or procedures may be allowed during the screening period at the discretion of the Investigator; the Medical Monitor should be consulted if needed. Screen failures are defined as subjects who consent to p... | [] |
NCT05014568 | 4.6 | Withdrawal Criteria | 4.6 Withdrawal Criteria A subject may voluntarily discontinue treatment and/or withdraw from participation in this study at any time at his/her own request or may be discontinued from study treatment at any time at the discretion of the Investigator for safety, behavioral, compliance, or administrative reasons. Subject... | [] |
NCT05014568 | 4.6.1 | Reasons for Withdrawal from the Study | 4.6.1 Reasons for Withdrawal from the Study Study drug will be discontinued and the subject withdrawn from the study for any of the following reasons: - Subject has an AE that is considered to be related to study drug or procedures AND is severe enough to warrant treatment discontinuation, as determined by the Investig... | [] |
NCT05014568 | 4.6.2 | Withdrawal Procedures | 4.6.2 Withdrawal Procedures The primary reason for the discontinuation of study drug and/or withdrawal from study must be recorded in the source document and on the case report form (CRF). If a subject is prematurely discontinued from study drug, the Investigator must make every effort to perform an Early Termination V... | [] |
NCT05014568 | 4.7 | Lost to Follow-Up | 4.7 Lost to Follow-Up A subject is considered lost to follow-up if he/she repeatedly fails to return to the study site for scheduled visits and is unable to be contacted by the study site. The following actions must be taken if a subject fails to return to the clinic for a required study visit: - The site must attempt ... | [] |
NCT05014568 | 5 | Study Treatment | 5 Study Treatment | [] |
NCT05014568 | 5.1 | Study Drug | 5.1 Study Drug | [] |
NCT05014568 | 5.1.1 | Description, Packaging, and Labeling Table 2: Tapinarof and Vehicle Cream | 5.1.1 Description, Packaging, and Labeling Table 2: Tapinarof and Vehicle Cream The descriptions of the study drugs, tapinarof cream, 1% and the vehicle cream, are presented in Table 2.  All labels for tapinarof cream, 1% and vehicle cream to be distributed in the participating countries will mee... | [] |
NCT05014568 | 5.1.2 | Storage | 5.1.2 Storage All study drugs must be stored in a secure, environmentally controlled and monitored (manual or automated) area in accordance with the labeled storage conditions, with access limited to the Investigator and authorized site staff. The study drug storage temperature range will be provided in the study refer... | [] |
NCT05014568 | 5.1.3 | Handling and Disposal | 5.1.3 Handling and Disposal Under normal conditions of handling and administration, study drug is not expected to pose significant safety risks to site staff. In the case of unintentional occupational exposure notify the monitor, Medical Monitor and/or the Sponsor study contact. Arrangements will be made for used and u... | [] |
NCT05014568 | 5.1.4 | Preparation | 5.1.4 Preparation No special preparation of study drug is required. | [] |
NCT05014568 | 5.1.5 | Administration of Study Drug | 5.1.5 Administration of Study Drug Study drug will be dispensed to subjects or their caregivers at the clinical site in appropriately labeled tubes. Subjects or caregivers will take the tubes home and self-administer study drug (or have caregiver apply if necessary) to affected areas QD, except on clinic visit days whe... | [] |
NCT05014568 | 5.1 | 6 | 5.1.6 | [] |
NCT05014568 | 5.2 | Randomization/Treatment Assignment | 5.2 Randomization/Treatment Assignment For the double-blind, vehicle-controlled phase of the study, subjects will be randomized at a ratio of 2:1 to receive tapinarof cream, 1% or vehicle cream as follows: | Randomization in Double-Blind, Vehicle-Controlled Phase | | | | |-----------------------------------------------... | [] |
NCT05014568 | 5.3 | Blinding | 5.3 Blinding The Investigator, study site staff, subject, and Sponsor will be blinded to treatment assignment. The study blind should not be broken except in medical emergencies when the appropriate management of the subject requires knowledge of the study drug the subject received. The following conditions will apply ... | [] |
NCT05014568 | 5.4 | Compliance with Study Drug Administration | 5.4 Compliance with Study Drug Administration At Baseline, study staff will provide the subject or caregiver with detailed instructions concerning protocol requirements and use of study drug. Additionally, subjects or caregivers will be asked to complete a daily diary with the time of each application of study drug, ex... | [] |
NCT05014568 | 5.5 | Treatment after the End of the Study | 5.5 Treatment after the End of the Study Subjects will not receive any additional treatment with the study drug from the Sponsor after completion of the study (with the exception of eligible subjects who enroll in the OL-LTE study) because the indication being studied is not life threatening or seriously debilitating a... | [] |
NCT05014568 | 5.6 | Prior and Concomitant Therapy | 5.6 Prior and Concomitant Therapy Any medication (including over the counter or prescription medication, vitamins and/or herbal supplements) administered to the subject up to 30 days before the Screening visit, at the time of enrollment, and during the study must be recorded in the CRF along with the reason for use. Th... | [] |
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