protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04495478 | 5.2 | Exclusion Criteria | 5.2. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply:
Medical Conditions 1. Have known allergies to ramucirumab, any components of the formulation buffer matrix or related compounds, or history of significant atopy 2. Have an abnormal blood pressure (>140/90 mmHg) and... | [
"Medical Conditions",
"Prior/Concomitant Therapy",
"Prior/Concurrent Clinical Study Experience",
"Diagnostic Assessments",
"Other Exclusions"
] |
NCT04495478 | 5.3 | Lifestyle Considerations | 5.3. Lifestyle Considerations
Meals and Dietary Restrictions There are no dietary restrictions for this study.
Caffeine, Alcohol, and Tobacco - 1. During each dosing session, participants will abstain from ingesting caffeine- or xanthine-containing products (for example, coffee, tea, cola drinks, and chocolate) for 2... | [
"Meals and Dietary Restrictions",
"Caffeine, Alcohol, and Tobacco",
"Activity"
] |
NCT04495478 | 5.4 | Screen Failures | 5.4. Screen Failures Screen failures are defined as participants who consent to participate in the clinical study but are not subsequently enrolled in the study and were not alternates. Individuals who do not meet the criteria for participation in this study (screen failure) may be rescreened. Alternates may also be re... | [] |
NCT04495478 | 6 | Study Intervention | 6. Study Intervention Study intervention is defined as any investigational intervention(s), marketed product(s), placebo, or medical device(s) intended to be administered to a study participant according to the study protocol. 6.1. Study Intervention(s) Administered | Intervention | Ramucirumab IV | Ramucirumab SC | Pl... | [
"Special Treatment Considerations"
] |
NCT04495478 | 6.1.1.1 | Premedication for Infusions and Subcutaneous Injections | 6.1.1.1. Premedication for Infusions and Subcutaneous Injections Premedication (with IV histamine H1 antagonists such as diphenhydramine hydrochloride) is planned prior to ramucirumab IV infusion as specified per label for IV administration. Participants receiving SC infusion/injection will also receive oral premedicat... | [] |
NCT04495478 | 6.1.1.2 | Management of Infusion Reactions | 6.1.1.2. Management of Infusion Reactions There is a risk of infusion reactions and anaphylaxis with any biological agent; therefore, all participants should be monitored closely. Symptoms and signs that may occur as part of an infusion reaction include, but are not limited to fever, chills, nausea, headache, bronchosp... | [] |
NCT04495478 | 6.2 | Preparation/Handling/Storage/Accountability | 6.2. Preparation/Handling/Storage/Accountability - 1. The investigator or designee must confirm appropriate temperature conditions have been maintained during transit for all study intervention received and any discrepancies are reported and resolved before use of the study intervention. - 2. Only participants enrolled... | [] |
NCT04495478 | 6.3 | Measures to Minimize Bias: Randomization and Blinding | 6.3. Measures to Minimize Bias: Randomization and Blinding | Study using | On Day 1,participants will be assigned a unique number (randomization | |------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Blinded study with unblinded site pharmacist who is dispensing drug",
"Package and Labeling"
] |
NCT04495478 | 6.4 | Study Intervention Compliance | 6.4. Study Intervention Compliance When the individual dose for a participant is prepared from a bulk supply, the preparation of the dose will be confirmed by a second member of the study site staff. When participants are dosed at the site, they will receive study intervention directly from the investigator or designee... | [] |
NCT04495478 | 6.5 | Concomitant Therapy | 6.5. Concomitant Therapy Participants must abstain from taking prescription or nonprescription drugs (including vitamins and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion o... | [] |
NCT04495478 | 6.6 | Dose Modification | 6.6. Dose Modification If moderate or severe AEs are consistently observed across participants in a group or if unacceptable pharmacological effects, reasonably attributable to ramucirumab administration in the opinion of the investigator, are observed in more than 2 of the participants in a group, then no further part... | [] |
NCT04495478 | 6.7 | Intervention after the End of the Study | 6.7. Intervention after the End of the Study Not applicable. | [] |
NCT04495478 | 7 | Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal | 7. Discontinuation of Study Intervention and Participant Discontinuation/Withdrawal Participants discontinuing from the study prematurely for any reason must complete AE and follow-up procedures per the SoA (Section [1.3\)](#page-14-0) of the protocol. | [] |
NCT04495478 | 7.1 | Discontinuation of Study Intervention | 7.1. Discontinuation of Study Intervention In rare instances, it may be necessary for a participant to permanently discontinue (definitive discontinuation) study intervention. If study intervention is definitively discontinued, the participant will remain in the study for additional data collection consistent with rout... | [] |
NCT04495478 | 7.2 | Participant Discontinuation/Withdrawal from the Study | 7.2. Participant Discontinuation/Withdrawal from the Study A participant may withdraw from the study: - at any time at his/her own request - at the request of his/her designee (for example, parents or legal guardian) - at the discretion of the investigator for safety, behavioral, compliance, or administrative reasons -... | [
"Discontinuation of Inadvertently Enrolled Participants"
] |
NCT04495478 | 7.3 | Lost to Follow-Up | 7.3. Lost to Follow-Up A participant will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel are expected to make diligent attempts to contact participants who fail to return for a scheduled visit or were otherwise... | [] |
NCT04495478 | 8 | Study Assessments and Procedures | 8. Study Assessments and Procedures Study procedures and their timing are summarized in the SoA (Section [1.3\)](#page-14-0). Protocol waivers or exemptions are not allowed. - Immediate safety concerns should be discussed with the sponsor immediately upon occurrence or awareness to determine if the participant should c... | [] |
NCT04495478 | 8.1 | Efficacy Assessments | 8.1. Efficacy Assessments Not applicable. | [] |
NCT04495478 | 8.2 | Safety Assessments | 8.2. Safety Assessments Planned time points for all safety assessments are provided in the SoA (Section [1.3\)](#page-14-0).
Physical Examinations A complete physical examination will include, at a minimum, assessments of the cardiovascular, respiratory, GI, and neurological systems. Height and weight will also be mea... | [
"Physical Examinations",
"Vital Signs",
"Electrocardiograms",
"Clinical Safety Laboratory Assessments",
"Injection Site Reactions",
"Safety Monitoring"
] |
NCT04495478 | 8.2.6.1 | Hypersensitivity Reactions | 8.2.6.1. Hypersensitivity Reactions In the event of a suspected systemic allergic/hypersensitivity reaction, additional safety data should be collected using the Infusion-related reaction/Hypersensitivity/Anaphylaxis follow-up form or documented via the eCRF. - Hypersensitivity/Infusion-Related Reactions eCRFs are used... | [] |
NCT04495478 | 8.3 | Adverse Events and Serious Adverse Events | 8.3. Adverse Events and Serious Adverse Events The definitions of AEs and SAEs are provided in [Appendix 3](#page-68-1) (Section [10.3\)](#page-68-1). The investigator will use CTCAE version 5.0 (NCI 2018) to assign AE severity grades. Adverse events will be reported by the participant (or, when appropriate, by a careg... | [
"Time Period and Frequency for Collecting AE and SAE Information",
"Method of Detecting AEs and SAEs",
"Follow-Up of AEs and SAEs",
"Regulatory Reporting Requirements for SAEs",
"Pregnancy",
"Adverse Events of Special Interest",
"Product Complaints"
] |
NCT04495478 | 8.3.7.1 | Time Period for Detecting Product Complaints | 8.3.7.1. Time Period for Detecting Product Complaints - Product complaints that result in an AE will be detected, documented, and reported to the sponsor during all periods of the study in which the drug is used. - If the investigator learns of any product complaint at any time after a participant has been discharged f... | [] |
NCT04495478 | 8.3.7.2 | Prompt Reporting of Product Complaints to Sponsor | 8.3.7.2. Prompt Reporting of Product Complaints to Sponsor Product complaints will be reported to the sponsor using the Product Complaint Form within 24 hours after the investigator becomes aware of the complaint. The Product Complaint Form will be sent to the sponsor by the method provided in the form. If the primary ... | [] |
NCT04495478 | 8.3.7.3 | Follow-Up of Product Complaints | 8.3.7.3. Follow-Up of Product Complaints - Follow-up applies to all participants, including those who discontinue study intervention. - The investigator is responsible for ensuring that follow-up includes any supplemental investigations as indicated to elucidate the nature and/or causality of the product complaint. - N... | [] |
NCT04495478 | 8.4 | Treatment of Overdose | 8.4. Treatment of Overdose For this study, any dose of ramucirumab greater than a single dose of study intervention within a 24-hour time period will be considered an overdose. The sponsor does not recommend specific treatment for an overdose. Participants should receive appropriate supportive care measures for AESIs o... | [] |
NCT04495478 | 8.5 | Pharmacokinetics | 8.5. Pharmacokinetics - Whole blood samples will be collected for measurement of serum concentrations of ramucirumab as specified in the SoA (Section [1.3\)](#page-14-0), Section [1.3.1,](#page-22-0) and Section [10.2.1.](#page-67-0) - A maximum of 3 samples may be collected at additional time points during the study i... | [
"Bioanalysis"
] |
NCT04495478 | 8.6 | Pharmacodynamics | 8.6. Pharmacodynamics Pharmacodynamic parameters are not evaluated in this study. | [] |
NCT04495478 | 8.7 | Genetics | 8.7. Genetics Genetics are not evaluated in this study. A blood sample for deoxyribonucleic acid (DNA) isolation will be collected from participants. See [Appendix 5](#page-76-0) (Section [10.5\)](#page-76-0) for information regarding genetic research and [Appendix 1](#page-60-2) (Section [10.1.9\)](#page-64-0) for det... | [] |
NCT04495478 | 8.8 | Biomarkers | 8.8. Biomarkers Biomarkers are not evaluated in this study. | [] |
NCT04495478 | 8.9 | Immunogenicity Assessments | 8.9. Immunogenicity Assessments At the visits and times specified in the SoA (Section [1.3\)](#page-14-0) and Section [1.3.1,](#page-22-0) venous blood samples will be collected to determine antibody production against ramucirumab. Antibodies may be further characterized for their ability to neutralize the activity of ... | [] |
NCT04495478 | 8.10 | Health Economics | 8.10. Health Economics This section is not applicable for this study. | [] |
NCT04495478 | 9 | Statistical Considerations | 9. Statistical Considerations | [] |
NCT04495478 | 9.1 | Statistical Hypotheses | 9.1. Statistical Hypotheses Formal statistical hypothesis testing is not planned. Therefore, adjustments for multiple testing do not apply. | [] |
NCT04495478 | 9.2 | Sample Size Determination | 9.2. Sample Size Determination Approximately 60 participants will be enrolled and randomly assigned to study intervention (10 per group/dose level; 7 ramucirumab:3 placebo) to obtain at least 48 evaluable participants overall for an estimated total of at least 8 evaluable participants per intervention group (6 ramuciru... | [] |
NCT04495478 | 9.3 | Populations for Analyses | 9.3. Populations for Analyses The following populations are defined: | Population | Description | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Study Participant Disposition",
"Study Participant Characteristics",
"Treatment Compliance"
] |
NCT04495478 | 9.4 | Statistical Analyses | 9.4. Statistical Analyses Statistical analysis of this study will be the responsibility of the sponsor or its designee. The primary analysis of the study will occur when there are at least 8 evaluable participants (6 ramucirumab:2 placebo) per intervention group. Pharmacokinetic analyses will be conducted on data from ... | [
"Safety Analyses"
] |
NCT04495478 | 9.4.1.1 | Clinical Evaluation of Safety | 9.4.1.1. Clinical Evaluation of Safety All IP and protocol procedure AEs will be listed, and if the frequency of events allows, safety data will be summarized using descriptive methodology. The incidence of AEs for each treatment will be presented by severity and by association with IP as perceived by the investigator.... | [] |
NCT04495478 | 9.4.1.2 | Statistical Evaluation of Safety | 9.4.1.2. Statistical Evaluation of Safety Safety parameters that will be assessed include safety laboratory parameters, vital sign measurements, and ECG parameters. The parameters will be listed, and summarized using standard descriptive statistics. Additional analysis will be performed if warranted upon review of the ... | [
"Pharmacokinetic Analyses"
] |
NCT04495478 | 9.4.2.1 | Pharmacokinetic Parameter Estimation | 9.4.2.1. Pharmacokinetic Parameter Estimation Pharmacokinetic parameter estimates for ramucirumab will be calculated by standard noncompartmental methods of analysis. The primary parameters for analysis will be tmax, Cmax, and AUC of ramucirumab following IV and SC administration and bioavailability following SC admini... | [] |
NCT04495478 | 9.4.2.2 | Pharmacokinetic Statistical Inference | 9.4.2.2. Pharmacokinetic Statistical Inference Pharmacokinetic parameters will be evaluated to estimate ramucirumab AUC and Cmax dose proportionality following SC administration in the dose range investigated. Log-transformed ramucirumab Cmax and AUC parameters will be evaluated in a linear mixed-effects model with fix... | [
"Other Safety Analyses",
"Immunogenicity Assessments",
"Other Analyses"
] |
NCT04495478 | 9.5 | Interim Analyses | 9.5. Interim Analyses No interim analyses are planned for this study. If an unplanned interim analysis is deemed necessary for reasons other than a safety concern, the protocol must be amended. However, there will be periodic reviews of data to assess safety, tolerability, and PK data. There will be sentinel dosing in ... | [] |
NCT04495478 | 9.6 | Data Monitoring Committee (DMC) | 9.6. Data Monitoring Committee (DMC) Not applicable. | [] |
NCT04495478 | 10 | Supporting Documentation and Operational Considerations | 10. Supporting Documentation and Operational Considerations | [] |
NCT04495478 | 10.1 | Appendix 1: Regulatory, Ethical, and Study Oversight Considerations | 10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
Regulatory and Ethical Considerations - This study will be conducted in accordance with the protocol and with the following: - o consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council... | [
"Regulatory and Ethical Considerations",
"Informed Consent Process",
"Data Protection",
"Dissemination of Clinical Study Data",
"Reports",
"Data",
"Data Quality Assurance",
"Data Capture System",
"Source Documents",
"Study and Site Start and Closure",
"Publication Policy",
"Long-Term Sample Re... |
NCT04495478 | 10.2 | Appendix 2: Clinical Laboratory Tests | 10.2. Appendix 2: Clinical Laboratory Tests - The tests detailed below will be performed by the local laboratory. - Protocol-specific requirements for inclusion or exclusion of participants are detailed in Section [5](#page-34-1) of the protocol. - Additional serum or urine pregnancy tests may be performed, as determin... | [
"Safety Laboratory Tests",
"Blood Sampling Summary"
] |
NCT04495478 | 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
Definition of AE
AE Definition - An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered rel... | [
"Definition of AE",
"AE Definition",
"Events Meeting the AE Definition",
"Events NOT Meeting the AE Definition",
"Definition of SAE",
"An SAE is defined as any untoward medical occurrence that, at any dose:",
"a. Results in death",
"b. Is life-threatening",
"c. Requires inpatient hospitalization or ... |
NCT04495478 | 10.4 | Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information | 10.4. Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information
Definitions:
Woman of Childbearing Potential (WOCBP) A woman is considered fertile following menarche and until becoming postmenopausal unless permanently sterile (see below). If fertility is unclear (for example, amenorrhea in adolescen... | [
"Definitions:",
"Woman of Childbearing Potential (WOCBP)",
"Contraception Guidance:",
"Collection of Pregnancy Information",
"Male participants with partners who become pregnant",
"Female participants who become pregnant"
] |
NCT04495478 | 10.5 | Appendix 5: Genetics | 10.5. Appendix 5: 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 e... | [
"Use/Analysis of DNA"
] |
NCT04495478 | 10.6 | Appendix 6: Pharmacokinetic Profile Simulation (Intravenous versus Subcutaneous) | 10.6. Appendix 6: Pharmacokinetic Profile Simulation (Intravenous versus Subcutaneous) The PK profile for IV (10 mg/kg Q2W) and SC administration of ramucirumab (Left panel: 1400-mg SC loading dose on Day 1 followed by QW SC 700 mg; Right panel: 1400-mg SC loading dose on Day 1 followed by twice-weekly [BIW] SC 350 mg)... | [] |
NCT04495478 | 10.7 | Appendix 7: Abbreviations | 10.7. Appendix 7: Abbreviations Term Definition ADA antidrug antibody AE adverse event AESI adverse event of special interest ATE arterial thromboembolic event AUC area under the concentration versus time curve BIW twice weekly blinding/masking A single-blind study is one in which the investigator and/or his staff are ... | [] |
NCT04495478 | 10.8 | Appendix 8: Protocol Amendment History | 10.8. Appendix 8: 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): 14 July 2020
Overall Rationale for the Amendment: This amendment addresses feedback from the United States Food and Drug Administr... | [
"Overall Rationale for the Amendment:",
"Amendment(a): 26 June 2020",
"Overall Rationale for the Amendment:"
] |
NCT04495478 | 11 | References | 11. References [FDA] United States Food and Drug Administration. Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics. Draft Guidance. Available at: https://www.fda.gov/media/115172/download. July 2018 (2018a). Accessed February 20, 2020. - [FDA] United States... | [] |
NCT04495478 | L | e o D o c u m e n t I D = 3 0 1 2 0 5 1 e - d c e 4 - 4 5 c 2 - b 0 d 3 - c 0 f 9 1 b 6 d 3 c e 2 | L e o D o c u m e n t I D = 3 0 1 2 0 5 1 e - d c e 4 - 4 5 c 2 - b 0 d 3 - c 0 f 9 1 b 6 d 3 c e 2 A p p r o v e r : P P D A p p r o v a l D a t e & T i m e : 2 1 - O c t - 2 0 2 0 1 2 : 1 8 : 5 7 G M T S i g n a t u r e m e a n i n g : A p p r o v e d A p p r o v e r : P P D A p p r o v a l D a t e & T i m e : 2 1 - ... | [] |
NCT04530162 | 1 | Subjects: | 1. Subjects: The study population is Maimonides Medical Center emergency department patients older than 18 years of age presenting with acute herpes zoster patient with characteristic dermatomal vesicular skin lesions within 30 days of initial symptoms. | [] |
NCT04530162 | 2 | Eligibility Criteria: | 2. Eligibility Criteria: The inclusion criteria are patient age over 18 with herpes zoster pain onset within 30 days of characteristic dermatomal herpes zoster rash. The exclusion criteria are allergy to bupivacaine, signs of infection over herpes zoster site, greater than 30 days duration of pain, pain across more tha... | [] |
NCT04530162 | 3 | Design: | 3. Design: The primary outcome is the percentage of patients who have significant herpetic pain at 1 month and 3 months after receiving the nerve block. Secondary outcomes measured are pain scores pre-injection, and 1 hour, 1 month, and 3 months post-nerve block. The number of tablets of opioids and other analgesics us... | [] |
NCT04530162 | 4 | Data Collection Procedures: | 4. Data Collection Procedures: The numerical verbal rating scale pain score will be recorded by a research staff member at 1 hour after administration of nerve block. The patients will then be called at 1 week, 1 month, and 3 months post nerve block for assessment of NRS as well as number of follow-up visits and amount... | [] |
NCT04530162 | 5 | Sample Size: | 5. Sample Size: Earlier studies show the incidence of post herpetic neuralgia to be up to 43% in patients who are diagnosed with acute herpes zoster.[14] We will calculate a sample size required to achieve an of 5 and power of 80% to detect a clinically relevant reduction in the incidence of PHN from 43% to 10%. We wil... | [] |
NCT04530162 | 6 | Expected Outcomes: | 6. Expected Outcomes: We expect that patients undergoing ultrasound guided nerve block will have decreased incidence of subacute herpetic neuralgia and PHN. We also expect pain to be well controlled at 1 hour, 1 week, 1 month, and 3 months post nerve block. | [] |
NCT04530162 | 7 | Adverse Event Reporting: | 7. Adverse Event Reporting: Side effects of local anesthetics are rare but usually target the central nervous system (numbness, metallic taste, anxiety, visual changes, muscle twitching, seizure, somnolence, coma, respiratory depression) and the cardiovascular system (hypertension or hypotension, tachycardia or bradyca... | [
"References"
] |
NCT04537715 | S | I G N A T U R E P A G E | S I G N A T U R E P A G E | [] |
NCT04537715 | S | p o n s o r' s A p p r o v al | S p o n s o r' s A p p r o v al T h e pr ot o c ol h a s b e e n a p pr o v e d b y E pi z y m e, I n c. | [] |
NCT04537715 | S | p o n s o r' s A ut h o ri z e d Offi c e r: | S p o n s o r' s A ut h o ri z e d Offi c e r: 
R e s p o n si bl e M e di c al Offi c e r: 
INVESTIGATOR'S AGREEMENT Protocol Title: A Phase I, Open-label Multi-dose Two-Part Study to Characterize the Effects of a Strong CYP3A4 Inhibitor on the Steady-State Pharmacokinetic... | [
"R e s p o n si bl e M e di c al Offi c e r:",
"INVESTIGATOR'S AGREEMENT",
"PROCEDURES IN CASE OF EMERGENCY",
"Emergency Contact Information",
"PROTOCOL AMENDMENT AND SUMMARY OF CHANGES",
"Amendment 2.0",
"Overall Rationale for the Amendment:",
"Details of substantial changes to the protocol include:"... |
NCT04537715 | S | e c o n d a r y | S e c o n d a r y - T o e v al u at e t h e st e a d y st at e s af et y pr ofil e of t a z e m et o st at w h e n c o a d mi ni st er e d a s a si n gl e a n d t wi c e d ail y or al d o s e wit h itr a c o n a z ol e i n s u bj e ct s wit h a d v a n c e d m ali g n a n ci e s. - T o e v al u at e t h e st e a d y st... | [
"P a rt 2: T a z e m et o st at a n d Rif a m pi n D r u g I nt e r a cti o n",
"P ri m a r y",
"Secondary:",
"Study Design:",
"Methodology:",
"Part 1: Tazemetostat and Itraconazole Drug Interaction",
"P a rt 2: T a z e m et o st at a n d Rif a m pi n D r u g I nt e r a cti o n",
"R oll o v e r St u d... |
NCT04549363 | 1 | PROTOCOL SUMMARY | 1 PROTOCOL SUMMARY | [] |
NCT04549363 | 1.1 | Synopsis | 1.1. Synopsis
Protocol Title: Characterization of Corneal Epithelial Changes in Participants Treated with Belantamab Mafodotin (GSK2857916)
Brief Title: Characterization of Corneal Epithelial Changes in Participants Treated with Belantamab Mafodotin (GSK2857916)
Rationale: Multiple myeloma (MM) is an incurable hemat... | [
"Protocol Title:",
"Brief Title:",
"Rationale:"
] |
NCT04549363 | O | bjecti ves a n d E n d p oi nts: | O bjecti ves a n d E n d p oi nts: | O bjecti ves | E n d p oi nts | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04549363 | O | ver all Desi g n: | O ver all Desi g n: T his st u d y will be a vaila ble t o a n y p artici pa nt w h o has recei ve d or is c urre ntl y recei vi n g bela nta ma b maf o d oti n treat me nt t hr o u g h eit her a cli nical trial, (i ncl u di n g a n i n vesti gat or s p o ns ore d st u d y [I S S], or a n access pr o gra m) or a P h ys... | [
"Brief S u m m a r y:",
"N u m ber of P artici p a nts:",
"1.2. Schema",
"1. 3. S c h e d ul e of A cti viti e s ( S o A)",
"2. I N T R O D U C TI O N",
"2. 1. St u d y R ati o n al e",
"2. 2. B a c k gr o u n d",
"2. 3. B e n efit s a n d Ri s k s"
] |
NCT04549363 | P | ai n: | P ai n: T he S K pr oce d ure ca n ca use pai n t o t he partici pa nt b ut is ge nerall y s afe a n d well t olerate d. Pai n ca n b e ma na ge d b y t he use of artifi cial tears or a ba n d a ge c o ntact le ns
I nfecti o n: T he S K pr oce d ure carri es a ris k of i nfecti o n a n d re q uires pr o p h yla ctic a... | [
"I nfecti o n:",
"Del a ye d He ali n g:",
"2. 3. 1. B e n efit A s s e s s m e nt",
"2. 3. 2. O v er all B e n efit/ Ri s k C o n cl u si o n",
"3. O B J E C TI V E S A N D E N D P O I N T S",
"4. S T U D Y D E SI G N",
"4. 1. O v er all D e si g n",
"4. 2. St u d y Pr o c e d ur e s",
"4.3. End of... |
NCT04562116 | 1 | CLINICAL STUDY PROTOCOL | 1 CLINICAL STUDY PROTOCOL An Open-label Drug-Drug Interaction Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Subjects with Moderate-to-Severe Atopic Dermatitis Protocol Number: RD.06.SPR.201593 EudraCT Number: 2020-000229-24 IND Number: 117122 Investigational Product: Nemolizumab (CD14152) ... | [
"CONFIDENTIAL",
"PROTOCOL APPROVAL SIGNATURES",
"Sponsor Signatory",
"STUDY PERSONNEL",
"GALDERMA S.A./GALDERMA R&D, LLC",
"Galderma S.A. Protocol: RD.06.SPR.201593 Nemolizumab (CD14152) 14SEPT2021"
] |
NCT04562116 | 2 | SYNOPSIS | 2 SYNOPSIS CCI | Title of Study: | An Open-label Drug-Drug Interaction Study to Assess the Effects of Nemolizumab onCytochrome P450 Substrates in Subjects with Moderate-to-Severe Atopic Dermatitis | |----------------------------------------------|-------------------------------------------------------------------------... | [
"Exclusion Criteria:",
"CYP Substrates",
"Moisturizer",
"Topical Background Therapy",
"Rescue Therapies"
] |
NCT04562116 | 4 | LIST OF ABBREVIATIONS | 4 LIST OF ABBREVIATIONS CCI ACT Asthma Control Test AD atopic dermatitis ADA anti-drug antibody AE adverse event AESI adverse event of special interest ALT alanine aminotransferase AST aspartate aminotransferase AUC area under the curve BLQ below the lower quantification limit BSA body surface area COVID-19 coronavirus... | [] |
NCT04562116 | 5 | INTRODUCTION | 5 INTRODUCTION | [] |
NCT04562116 | 5.1 | Background and Rationale | 5.1 Background and Rationale Atopic dermatitis (AD) is a chronic inflammatory skin disease estimated to occur in 10% to 20% of the population (Weidinger 2016) and in up to 25% of children (Eichenfield 2014). The disease is characterized by pruritus (itching), xerosis (skin dryness), and eczematous lesions whose feature... | [] |
NCT04562116 | 5.1.1 | Justification of Study | 5.1.1 Justification of Study Cytochrome P450 (CYP450) isozymes are down-regulated in response to inflammation and infection leading to altered metabolism of small molecule drugs. In patients with inflammatory diseases associated with systemic inflammation, down-regulation of CYP450 can affect drug disposition with incr... | [
"Justification of Patient Population",
"Justification of Substrates",
"Justification of Study Duration",
"Phase 2b Dose-Ranging Study in Atopic Dermatitis",
"Phase 2a Safety and Efficacy Study in Prurigo Nodularis",
"Phase 3 Pivotal Studies in Adult and Adolescent Subjects",
"Phase 3 Long-Term Efficacy ... |
NCT04562116 | 5.4 | Risk/Benefit Assessment | 5.4 Risk/Benefit Assessment | [] |
NCT04562116 | 5.4.1 | Nemolizumab | 5.4.1 Nemolizumab Results of previous clinical studies in adults demonstrated that treatment with nemolizumab had a marked effect on AD and PN, pruritus, and pruritus-related sleep loss. Nemolizumab 'was also well tolerated overall when used as monotherapy or concomitantly with a TCS. Based on the currently available i... | [] |
NCT04562116 | 5.4.2 | CYP Substrates | 5.4.2 CYP Substrates During the study, subjects will also receive CYP substrates (Caffeine 100 mg, Warfarin Sodium 10 mg, Midazolam 2 mg, Omeprazole 20 mg, and Metoprolol Tartrate 100 mg). Contraindications, risks, warnings, and precautions of CYP substrates are as outlined in their respective prescribing information. ... | [] |
NCT04562116 | 5.6 | Dose Selection Rationale | 5.6 Dose Selection Rationale The nemolizumab PK profile was extensively assessed in subjects with AD in multiple clinical studies after single and repeated doses (Studies CIM001JP, CIM003JG, and SPR.114322). The nemolizumab PK profile was also assessed after multiple doses in subjects with PN (Study SPR.115828). Simila... | [] |
NCT04562116 | 6 | STUDY OBJECTIVES AND ENDPOINTS 6.1 Primary Objective(s) | 6 STUDY OBJECTIVES AND ENDPOINTS 6.1 Primary Objective(s) The primary objective is to evaluate the effect of nemolizumab (CD14152) on the PK of a drug "cocktail" representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult subjects with moderate-to-severe AD. | [] |
NCT04562116 | 6.2 | Secondary Objective | 6.2 Secondary Objective The secondary objective is to assess the safety of nemolizumab. 6.3 Primary Endpoint(s) The primary endpoint(s) include: e Change of PK parameters (AUCo-inf, AUCo-1ast and Cmax) in the 5 probe drugs administered concomitantly [Caffeine (Jet-Alert Regular Strength Caffeine), 'Warfarin Sodium, Ome... | [] |
NCT04562116 | 7 | INVESTIGATIONAL PLAN | 7 INVESTIGATIONAL PLAN | [] |
NCT04562116 | 7.1 | Overall Study Design and Plan: Description | 7.1 Overall Study Design and Plan: Description This is an open-label, single sequence drug-drug interaction study in approximately 25 adult subjects aged > 18 years with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s) within 6 months of screenin... | [
"Restrictions",
"Diet and Lifestyle"
] |
NCT04562116 | 7.2 | Discussion of Study Design | 7.2 Discussion of Study Design | [] |
NCT04562116 | 7.2.1 | Study Design | 7.2.1 Study Design Based on the results of the prior Phase 2b study, the fixed dose of 30 mg (with a loading dose of 60 mg) was chosen to be administered Q4W in this clinical trial. The selected dose provided the best risk/benefits ratio in adults and is expected to provide a similar efficacy and safety profile in this... | [] |
NCT04562116 | 8.1 | Number of Planned Subjects | 8.1 Number of Planned Subjects Approximately 25 subjects aged > 18 years are planned to be enrolled in this study. 8.2 Inclusion Criteria To be eligible for study entry, subjects must satisfy all of the following criteria: - 1. Subjects aged > 18 years at the time of screening. - 2. Chronic AD for at least 2 years befo... | [
"Criteria"
] |
NCT04562116 | 8.4 | Rescreening | 8.4 Rescreening Screen failures may be allowed to rescreen up to 1 time unless the reason for screen failure is related to disease severity inclusion criteria (IGA, EASI, BSA, and PP NRS). The latter subjects are not permitted to rescreen. Subjects who are rescreened must sign a new ICF and be assigned a new subject id... | [] |
NCT04562116 | 8.6 | Pregnancy | 8.6 Pregnancy The safety of nemolizumab in pregnant or lactating women has not been established. Subjects will be instructed that known or suspected pregnancy occurring during the study should be confirmed and reported to the investigator. Ifa subject becomes pregnant, the investigator must withdraw the subject from th... | [] |
NCT04562116 | 8.8.1 | Imvestigational Product Administration | 8.8.1 Imvestigational Product Administration Nemolizumab (CD14152) 30 mg will be provided as lyophilized powder for solution for subcutaneous use only after reconstitution in a pre-filled, single-use, DCS. Each DCS is designed to deliver a 30-mg dose of CD14152 after reconstitution. Subjects will receive a loading dose... | [
"Identity of Investigational Products",
"Investigational Products Packaging and Labeling",
"Investigational Products Management",
"Storage",
"Accountability",
"Dispensing and Return",
"Method of Assigning Subject Numbers",
"Selection of Doses in the Study",
"Dose Modification",
"Treatment Complian... |
NCT04562116 | 8.9 | Probe Drugs - CYP Substrates | 8.9 Probe Drugs - CYP Substrates At the baseline and Week 10 visits, subjects will receive 1 single oral dose of selected, commercially available, CYP substrates [Caffeine (Jet-Alert Regular Strength Caffeine) 100 mg, Warfarin Sodium 10 mg, Midazolam 2 mg, Omeprazole 20 mg, and Metoprolol Tartrate 100 mg] administered ... | [] |
NCT04562116 | 8.9.1 | Preparation and Administration of CYP Substrates | 8.9.1 Preparation and Administration of CYP Substrates Study staff will administer the CYP substrates at the study center according to the respective commercially available prescribing information, except for Midazolam. Midazolam solution for injection will be administered orally, mixing 2 mL of solution with 120 mL of... | [
"Packaging, Labeling, and Storage of CYP Substrates"
] |
NCT04562116 | 8.9.2 | CYP Substrate Accountability and Compliance | 8.9.2 CYP Substrate Accountability and Compliance CYP substrates will be provided to the investigational study center. Ifa damaged shipment is received and/or a temperature excursion has been experienced, site personnel will notify the sponsor/contract research organization (CRO) and follow the guidelines according to ... | [] |
NCT04562116 | 8.10 | Blinding | 8.10 Blinding This is an open-label study. | [] |
NCT04562116 | 8.11 | Prior and Concomitant Therapy | 8.11 Prior and Concomitant Therapy Previous therapies are defined as therapies that have been stopped within the 3 months before the screening visit, unless relevant to the inclusion/exclusion criteria. Whenever possible, previous therapies for AD should be documented. Concomitant therapies/medications are defined as f... | [
"Permitted Concomitant Therapy",
"Moisturizer",
"Background Topical Therapy",
"Rescue Therapy",
"Prohibited Medication/Therapy"
] |
NCT04562116 | 8.12 | Duration of Subject Participation | 8.12 Duration of Subject Participation The expected duration for each subject's participation in the study will be approximately 25 weeks, including up to a 4-week screening period, a 1-week predose period, a 12-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection). | [] |
NCT04562116 | 8.12.1 | Early Termination Visit | 8.12.1 Early Termination Visit Subjects who discontinue prematurely from the study should complete an ET visit and a follow-up visit (12 weeks after the last study drug injection). | [] |
NCT04562116 | 8.12.2 | Unscheduled Visit | 8.12.2 Unscheduled Visit The subject should be reminded to adhere to the study schedule. Unscheduled visits may include but are not limited to repeat testing for abnormal laboratory results or follow-up of AEs. PK and ADA analyses are obligatory only at unscheduled visits that are conducted for safety reasons. Visits o... | [] |
NCT04562116 | 9 | STUDY ASSESSMENTS | 9 STUDY ASSESSMENTS Subjects will provide written informed consent, assent, and Health Insurance Portability and Accountability Act (HIPAA) authorization before any study-related procedures are performed. Upon provision of the signed ICF, each subject will be assigned a unique SIN. For the duration of the entire clinic... | [] |
NCT04562116 | 9.3.1 | Blood Sampling | 9.3.1 Blood Sampling Nemolizumab/ADA: Blood samples will be collected according to the schedule of assessments profile of nemohzmnab and ADA. At each sampling time point for PK assessment, collected blood will be placed to clot at room temperature (no more than 30 minutes after collection) and then centrifuged. The ser... | [
"CD14152 and CYP Substrates Quantification in Blood Sampling",
"Pharmacokinetic Parameters"
] |
NCT04562116 | 9.3.3 | Immunogenicity | 9.3.3 Immunogenicity According to the schedule of assessments (Table 1) and the clinical laboratory manual, blood samples will be collected to assess anti-nemolizumab ADA, which will be determined at these time points by the designated CRO using a validated enzyme-linked immunosorbent assay screening assay. The serum c... | [] |
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