protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03971422 | 9.8.1 | Interim analysis | A formal interim analysis is planned for this study at the end of Stage 1, once approximately (see Section 9.9 for sample size details) enrolled study participants ) are evaluable for the primary endpoint (having completed up to Day 43). Study enrollment will not be halted during planned IDMC review of the safety and e... | [
"Early stopping for Efficacy",
"Early Stopping for Futility",
"Dose Selection",
"Sample Size Re-estimation"
] |
NCT03971422 | 9.8.2 | Periodic Data Reviews | Approximately 3 periodic data reviews (in addition to the futility analysis) will be performed for the IDMC to oversee the safety of the study: the first periodic data review will be performed when approximately study participants have completed the 6-week Treatment Period; the second periodic data review will be condu... | [] |
NCT03971422 | 9.8.3 | Data monitoring | Data from the interim analysis will be presented to and reviewed by the IDMC by an unblinded statistician who will receive data from an independent statistical center. All information including electronic data capture, randomization and drug kit numbers are contained in a single database. The randomization and drug kit... | [] |
NCT03971422 | 9.9 | Determination of sample size | As detailed in in Section [9.8,](#page-82-2) this study may consist of 2 stages, with a formal interim analysis at the end of Stage 1.
Based on historical data, the difference in adjusted changes from Baseline of MG-ADL at Day 43, between rozanolixizumab and placebo, is assumed to be to and the standard deviation is a... | [] |
NCT03971422 | 10 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | [] | |
NCT03971422 | 10.1 | Appendix 1: Regulatory, ethical, and study oversight considerations | [] | |
NCT03971422 | 10.1.1 | Regulatory and ethical considerations | The study will be conducted under the auspices of an IRB/IEC, as defined in local regulations, International Council on Harmonisation-Good Clinical Practice (ICH-GCP), and in accordance with the ethical principles that have their origin in the Declaration of Helsinki.
UCB or designee will ensure that an appropriately ... | [] |
NCT03971422 | 10.1.2 | Financial disclosure | Insurance coverage will be handled according to local requirements.
Finance and insurance are addressed in the Investigator and/or CRO agreements, as applicable.
Confidential Page 87 of 188 | [] |
NCT03971422 | 10.1.3 | Informed consent process | Participant's informed consent, as well as a separate informed consent for the sub-study, must be obtained and documented in accordance with local regulations, ICH-GCP requirements, and the ethical principles that have their origin in the principles of the Declaration of Helsinki. A separate informed consent may be obt... | [] |
NCT03971422 | 10.1.4 | Data protection | UCB staff (or designee) will affirm and uphold the study participant's confidentiality. Throughout this study, all data forwarded to UCB (or designee) will be identified only by the study participant number assigned at Screening.
The Investigator agrees that representatives of UCB, its designee, representatives of the... | [] |
NCT03971422 | 10.1.5 | Committees structure | An IDMC will review the safety and tolerability data in this study in order to make recommendations for the Sponsor to decide on whether to proceed with the study.
The data review by the IDMC will be unblinded data.
An IDMC will be set up in line with the Food and Drug Administration regulatory requirements and Europ... | [] |
NCT03971422 | 10.1.6 | Data quality assurance | All participant data relating to the study will be recorded on printed or eCRF unless transmitted to the sponsor or designee electronically (eg, laboratory data). The Investigator is responsible for verifying that data entries are accurate and correct by physically or electronically signing the eCRF.
The Investigator ... | [] |
NCT03971422 | 10.1.6.1 | Electronic Case Report Form completion | The Investigator is responsible for prompt reporting of accurate, complete, and legible data in the eCRFs and in all required reports.
Confidential Page 89 of 188
Any change or correction to the eCRF after saving must be accompanied by a reason for the change.
Corrections made after the Investigator's review and app... | [] |
NCT03971422 | 10.1.6.2 | Apps | Not applicable. | [] |
NCT03971422 | 10.1.7 | Source documents | All source documents must be accurate, clear, unambiguous, permanent, and capable of being audited. They should be made using some permanent form of recording (ink, typing, printing, optical disc). They should not be obscured by correction fluid or have temporary attachments (such as removable self-stick notes). Photoc... | [] |
NCT03971422 | 10.1.8 | Study and Site Closure | The sponsor designee reserves the right to close the study site or terminate the study 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 collected and a study-site... | [] |
NCT03971422 | 10.1.9 | Publication Policy | The results of this study may be published or presented at scientific meetings.
The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication of multicenter studies only in their entirety and no... | [] |
NCT03971422 | 10.2 | Appendix 2: Clinical Laboratory Tests | - The tests detailed in the table 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 treatment administration and/or response evaluation. If a local sample is required, it is importan... | [
"Protocol-Required Safety Laboratory Assessments",
"NOTES :"
] |
NCT03971422 | 10.3 | Appendix 3: Adverse Events – Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting | [] | |
NCT03971422 | 10.3.1 | Definition of AE |
- An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
- NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), sympt... | [
"AE Definition",
"Events Meeting the AE Definition",
"Events NOT Meeting the AE Definition"
] |
NCT03971422 | 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 (eg, hospitalization for signs/symptoms of the disease under study, death due to progression of disease).
The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant... | [
"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 prolongation of existing hospitalization",
"d. Results in persistent disability/incapacity",
"e. Is a congenital anomaly/birth defect",
"f... |
NCT03971422 | 10.3.3 | Recording and Follow-Up of AE and/or SAE |
- When an AE/SAE occurs, it is the responsibility of the Investigator to review all documentation (eg, hospital progress notes, laboratory reports, and diagnostics reports) related to the event.
- The Investigator will then record all relevant AE/SAE information in the eCRF.
- It is not acceptable for the Investigato... | [
"AE and SAE Recording",
"Assessment of Intensity",
"Assessment of Causality",
"Follow-up of AEs and SAEs"
] |
NCT03971422 | 10.3.4 | Reporting of SAEs |
- The primary mechanism for reporting an SAE to UCB will be the electronic data collection tool. PUBLIC COPY
- If the electronic system is unavailable for more than 24 hours, then the site will use the paper SAE data collection tool (see next section).
- The site will enter the SAE data into the electronic system as ... | [
"SAE Reporting to UCB via an Electronic Data Collection Tool",
"SAE Reporting to UCB via Paper CRF"
] |
NCT03971422 | 10.4 | Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information |
A woman is considered fertile following menarche and until becoming post-menopausal unless permanently sterile (see below).
Women in the following categories are not considered WOCBP:
- 1. Premenarchal
- 2. Premenopausal female with 1 of the following:
- − Documented hysterectomy
- − Documented bilateral salp... | [
"Definitions",
"Woman of Childbearing Potential (WOCBP)",
"Contraception Guidance",
"Male participants",
"Female participants",
"Table 10-1: Highly Effective Contraceptive Methodsa",
"Highly Effective Contraceptive Methods That Are User Dependentb",
"Highly Effective Methods That Are User Independentb... |
NCT03971422 | 10.6 | Appendix 6: Liver Safety – Suggested Actions and Follow-up Assessments | Table 10‒2: Liver Chemistry Stopping Criteria and Follow-Up assessments
| | ... | [
"MONITORING:",
"For bilirubin or INR criteria",
"For all other criteria",
"• For bilirubin or INR criteria:",
"Liver Chemistry Increased Monitoring Criteria Criteria Actions ALT 5xULN and <8xULN and bilirubin <2xULN without symptoms believed to be related to liver injury or hypersensitivity, and who can be ... |
NCT03971422 | 10.7 | Appendix 7: Medical Device Incidents – Definition and Procedures for Recording, Evaluating, Follow-up, and reporting | PUBLIC COPY
Not applicable. This document cannot be used to support any marketing authorization application and any extensions or variations thereof. | [] |
NCT03971422 | 10.8 | Appendix 8: Rapid Alert Procedures | Not applicable.
PUBLIC COPY This document cannot be used to support any marketing authorization application and any extensions or variations thereof. UCB 23 Feb 2021 Clinical Study Protocol Rozanolixizumab MG0003 | [] |
NCT03971422 | 10.9 | Appendix 9: Country-specific Requirements | Not applicable.
PUBLIC COPY This document cannot be used to support any marketing authorization application and any extensions or variations thereof. | [] |
NCT03971422 | 10.10 | Appendix 10: Abbreviations and Trademarks | | AChE | acetylcholinesterase |
|--------------------|-----------------------------------------------------------|
| AChR | thereof.acetylcholine receptor |
| ADA | anti-drug antibody ... | [] |
NCT03971422 | 10.11 | Appendix 11: Protocol Amendment History |
| | The primary reason for this protocol amendment is to introduce the MG0007 study as theopen-label extension (OLE) study to MG0003 and closure of MG0004 once MG0007 study isavailable, decrease the complexity of assessments to be per... | [
"Amendment 3 (29 Jul 2020)",
"Overall Rationale for the Amendment",
"Amendment 2 (04 Mar 2020)",
"Overall Rationale for the Amendment",
"Amendment 1 (30 Oct 2019)",
"Overall Rationale for the Amendment"
] |
NCT03971422 | 10.12 | Appendix 12: MGFA Classification | PUBLIC COPY
This document cannot be used to support any marketing authorization application and any extensions or variations thereof.
The following information (eg, questionnaire) is copyrighted and UCB does not have permission to disclose the contents. PUBLIC COPY This document cannot be used to support any marketin... | [] |
NCT03971422 | 10.14 | Appendix 14: MG Composite Scale | |--|--|--|--|--|--|--|--|
| | | | | | thereof. |
|-------------|-------------|----------------------------------|-------------------|------------|------------|
| | | | ... | [] |
NCT03971422 | 10.17 | Appendix 17: Patient Global Impression of Severity | This document cannot be used to support any marketing authorization application and any extensions or variations thereof. | [] |
NCT03971422 | 10.18 | Appendix 18: Patient Global Impression of Change | | | thereof. |
|-------------------|-------------------------------------|
| | variationsor |
| | extensionsd any |
| | an |
| | ... | [] |
NCT03971422 | 10.21 | Appendix 21: MG-QOL15r | | | | | | | thereof. |
|--------------|-----------|--------------------------------|-------------|-------|------------|
| | | | | | variations |
| | | ... | [] |
NCT03971422 | 10.23 | Appendix 23: Management of Headache | Based on current available clinical data, headache is the most commonly reported adverse drug reaction in study participants treated with rozanolixizumab. Study participants should be well informed of this potential adverse drug reaction and should be instructed on how to manage it.
Determination of the severity of he... | [] |
NCT03971422 | 10.24 | Appendix 24: Management of Diarrhea | Severe (Grade 3) diarrhea is defined as an increase of ≥7 stools per day or hospitalization for management of diarrhea or limiting self-care ADL. Determination of the severity of diarrhea will be consistent with CTCAE version 5.0 (see Appendix 3, Section 10.3).
Diarrhea will be treated as clinically indicated accordin... | [] |
NCT03971422 | 10.25 | Appendix 25: Management of Infections and Hypogammaglobulinemia | Study participants who have signs or symptoms of any infection should be monitored closely and managed according to local guidelines. This may include tests for specific organisms if clinically indicated.
Study participants MUST discontinue IMP AND move into the SFU Period if any of the following events occur: Study p... | [] |
NCT03971422 | 10.26 | Appendix 26: Management of Infusion Reactions or Hypersensitivity Reactions | Table 10-4: Suggested management guidelines for infusion reactions or anaphylaxis
| extensionsType of reactionSuggested actionAcute –MildMonitor vital signs every 10 min.Grade 1If the reaction worsens to Grade 2, follow the instruction below.d anyAcute –ModerateInterrupt/hold infusion temporarily to further assess and... | [] |
NCT03971422 | 10.28 | Appendix 28: Sampson Criteria Questionnaire | Anaphylaxis is highly likely when any of the following 3 criteria is fulfilled (Sampson et al, 2006):
1. Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (eg, generalized hives, pruritus or flushing, swollen lips-tongue-uvula)
- a. Respiratory compromise (eg, ... | [
"AND AT LEAST ONE OF THE FOLLOWING"
] |
NCT03971422 | 11 | REFERENCES | American Psychiatric Association (US). Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington: American Psychiatric Association; 2013
Barnett C, Katzberg H, Nabavi M, Bril V. The quantitative myasthenia gravis score: comparison with clinical, electrophysiological, and laboratory markers. J Clin Neuro... | [
"Approval Signatures"
] |
NCT04420221 | 1 | Sponsor | GlaxoSmithKline Biologicals SA Rue de l'Institut 89, 1330 Rixensart, Belgium | [] |
NCT04420221 | 2 | Sponsor Medical Expert for the Study | Refer to the local study contact information document. | [] |
NCT04420221 | 3 | Sponsor Study Monitor | Refer to the local study contact information document. | [] |
NCT04420221 | 4 | Sponsor Study Contact for Reporting of a Serious Adverse Event | GSK Central Back-up Study Contact for Reporting SAEs: refer to protocol Section [12.5.9.3](#page-143-0)
Study Contact for Reporting SAEs: refer to the local study contact information document. | [] |
NCT04420221 | 5 | GSK Central Safety Physician On-Call Contact information for Emergency Unblinding | GSK Central Safety Physician and Back-up Phone contact: refer to protocol Section [7.3.1.](#page-70-0)
208833 (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final
Table 1 Document history
| Document | Date | |
|-------------------|---------------------|--|
| Amendment 6 | 6 Octobe... | [
"PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE",
"Amendment 6: 6 October 2022",
"List of main changes in the protocol and their rationale"
] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final |
| | | | | PAGE |
|----|------|---------------------|----------------------------------------------------------------------------------------------------------------------|--... | [
"TABLE OF CONTENTS"
] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) | Protocol Amendment 6 Final
| | | 12.6.1.1.1. | Women in the following categoriesare not considered WOCBP145 | |
|-------|---------|------------------------------------------|-------------------------------------------------------------------|--|
| | 12.6.2. | ... | [] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final |
| | | PAGE |
|----------|------------------------------------------------------------------------------------------------|------|
| Table 1 | Document history8 ... | [
"LIST OF TABLES"
] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final Table 22 [Reporting periods for collecting safety information \(PoP\)](#page-86-0) .......................86 Table 23 [Timeframes for submitting serious adverse event, pregnancy and](#page-87-2) [other events reports to GSK.......................................... | [parameters evaluated in the current study............................................148](#page-148-0) | [] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final |
| | | PAGE |
|-----------|-------------------------------------------------------------------------------------------------... | [
"LIST OF FIGURES",
"1. SYNOPSIS",
"Indication:",
"Rationale:",
"Objectives and Endpoints:",
"Overall Design:"
] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final |
Grp = Group
a/b = vaccine/placebo.
Rando = Randomisation
adj = adjuvanted
SE = Safety evaluation by SRT/ iSRC chair (blinded review) or iSRC (unblinded review), for details refer to Section [8.6](#page-90-3)
PoP = Proof of Principle
Figure 2 Study design overview dose-escalation saf... | [
"Figure 1 Overall design",
"Dose-Escalation safety lead-in healthy subjects",
"PoP in subjects with recent S. aureus SSTI",
"2. SCHEDULE OF ACTIVITIES (SOA)",
"Table 2 Schedule of activities (dose-escalation safety lead-in epochs, Groups 1-3a/b)"
] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | | Epoch | | Dose-escalation safety lead-in screening | | Dose-escalation safety lead-in vaccination | | | | |
|-------------------------------------|-... | [] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | .
| Epoch | | Dose-escalation safety leadin screening | Dose-escalation safety lead-in vaccination | | | | | | ... | [] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | | Epoch | PoP | | | | | | PoP vaccination | | | | | |
|--------------------------------------------------------|-----------|--------------|-----------------|-----|--------|--... | [
"3. INTRODUCTION",
"3.1. Study rationale",
"3.2. Background",
"3.2.1. Skin and soft tissue infections caused by S. aureus",
"3.3. Benefit/Risk assessment",
"3.3.1. Risk assessment",
"3.3.2. Benefit assessment",
"3.3.3. Overall Benefit: Risk conclusion",
"4. OBJECTIVE(S) AND ENDPOINT(S)",
"5. STUDY... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final |
adj = adjuvanted
Grp = Group
a/b = vaccine/placebo
Rando = Randomisation
SE = Safety evaluation by SRT/ iSRC chair (blinded review) or iSRC (unblinded review), for details refer to Section [8.6](#page-90-3)
PoP = Proof of Principle
Figure 5 Study design overview dose-escalation safe... | [
"Figure 4 Overall design",
"5.2.1. Dose-Escalation safety lead-in healthy subjects (Phase I)",
"• Duration of the study:",
"5.2.2. PoP in subjects with recent S. aureus SSTI Group 5a/b (Phase II)",
"Figure 6 Study design overview PoP in subjects with a recent S. aureus SSTI",
"• Sampling schedule:",
"• ... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | SPM = Study
| Study TreatmentName: | Sa-5Ag half dose nonadjuvanted | Sa-5Ag full dose nonadjuvanted | Sa-5Ag half dose adjuvanted | Sa-5Ag full dose adjuvanted * | Placebo |
|-------------------------------------------|------------------------------------|------------... | [
"7.2. Method of treatment assignment",
"7.2.1. Subject identification",
"7.2.2. Randomisation of treatment",
"7.2.2.1. Treatment allocation to the subject",
"7.2.2.1.1. Study group and treatment number allocation",
"Dose-escalation safety lead-in:",
"PoP:",
"7.2.2.1.2. Treatment number allocation for ... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | FAS: Full Analysis Set
FDA: Food and Drug Administration, United States of America
FTIH: First Time in Human
GCP: Good Clinical Practice
GSK: GlaxoSmithKline
CCI CCI
HR: Hazard Ratio
IB: Investigator Brochure
ICF: Informed Consent Form
ICH: International Council on Harmonisation
IEC: Independent Ethics Commit... | [
"12.1.2. Glossary of terms",
"12.2. Appendix 2: Clinical and safety laboratory tests",
"12.2.2. Laboratory assays for safety evaluation",
"12.3. Appendix 3: Clinical laboratories",
"12.4. Appendix 4: Study governance considerations",
"12.4.1. Regulatory and ethical considerations",
"12.4.2. Financial di... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | | | Clinicaltrial.gov | EU |
|------------------|---------------------------------------------------... | [
"12.4.7. Data quality assurance",
"12.4.8. Source documents",
"12.4.9. Study and site start and closure",
"First act of recruitment",
"Study/Site termination",
"12.5. Appendix 5: Adverse Events: definitions and procedures for recording, evaluating, follow-up, and reporting",
"12.5.1. Definition of AE",
... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | | Vasculitis ... | [
"12.5.6. Clinical laboratory parameters and other abnormal assessments qualifying as adverse events or serious adverse events",
"12.5.7. Events or outcomes not qualifying as adverse events or serious adverse events",
"12.5.7.1. Pregnancy",
"12.5.8. Detecting and recording adverse events, serious adverse event... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) | Protocol Amendment 6 Final
| Section # and Name | Description of Change | Brief Rationale | | | | |
|-------------------... | [
"In the Title page:",
"In Section 10.2. Sample size calculation:",
"12.8.2. Protocol Amendment 5",
"List of main changes in the protocol and their rationale",
"In the Title page:",
"The following change in units:",
"In Section 2 Schedule of Activities (SOA), Table 4:",
"In Section 2 Schedule of Activi... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | SPM = Study
| Study TreatmentName: | Sa-5Ag half dose nonadjuvanted | Sa-5Ag full dose nonadjuvanted | Sa-5Ag half dose adjuvanted | Sa-5Ag full dose adjuvanted * | Placebo |
|-------------------------------------------|------------------------------------|------------... | [
"In Section 7.1 Treatments Administered",
"In Section 8.6.3. Study holding rules",
"In Section 12.3. Clinical laboratories Table 29",
"In Section 12.5.2. Definition of SAE",
"In Section 12.5.8.2.2. Assessment of adverse events",
"12.8.3. Protocol Amendment 4",
"List of main changes in the protocol and t... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | | Epoch | PoP | | | | | | PoP vaccination | | | | | |
|--------------------------------------------------------|-----------|-------|-----------------|-----|--------|------|----------------... | [
"In Section 2 Schedule of Activities (SOA), Table 7 and footnote:",
"In Section 3.2.2 GSK Biologicals Staphylococcus aureus candidate vaccine:",
"In Section 5.2 Overall design, Figure 4:",
"Duration of the study:",
"Study groups, Table 11:",
"Sampling schedule:",
"In Section 6.1 Inclusion criteria for e... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | | Study Treatment | Sa-5Ag half dose non | Sa-5Ag full dose non | Sa-5Ag half dose adjuvanted | Sa-5Ag full dose adjuvanted * | Placebo |
|------------------------------------|-------------------------------|-------------------------------|-----------------------------... | [
"In Section 7.3.1 Emergency unblinding, Table 13:",
"GSK Helpdesk",
"In Section 7.5.2 Concomitant medications/products/vaccines that may lead to the elimination of a subject from per-protocol analyses",
"In Section 8.3 Case definition of recurrent S.aureus SSTI:",
"In Section 8.4.2.1 Sampling for efficacy a... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final |
Synopsis Figure 3 Study design overview PoP in subjects with a recent *S. aureus* SSTI Group 5a/b
Note: CDISC is not calculating with Day 0, i.e. interval between Day –14 and Day 1 is 14 days.
a/b = vaccine/placebo
SE = Safety evaluation by iSRC (unblinded review), for details refer t... | [
"Synopsis Figure 3 Study design overview PoP in subjects with a recent S. aureus SSTI Group 5a/b",
"Section 2 SCHEDULE OF ACTIVITIES",
"Table 3 Schedule of activities (dose-escalation safety lead-in epochs, Groups 1-3a/b)"
] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | .
| Epoch | | Dose-escalation safety lead-in screening | Dose-escalation safety lead-in vaccination | | | | |... | [] |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | | Epoch | PoP | | | | | | | | PoP vaccination | | | |
|-------------------------------------------------... | [
"Section 4. OBJECTIVE(S) AND ENDPOINT(S)",
"Section 5.1. Scientific rationale for study design",
"Section 5.2 Overall design",
"Figure 1 Overall design",
"Section 5.3. Number of subjects",
"PoP epochs:",
"Section 7.2.2.1.1. Study group and treatment number allocation",
"PoP:",
"Section 7.3.1. Emerge... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) | Protocol Amendment 6 Final
| Endpoint | Statistical Analysis Methods |
|----------|----------------------------------------------------------------------------------------------------|
| | In order to check the statistical significance, 1-s... | [
"Section 12.5.3. Solicited adverse events",
"b. Solicited general adverse events",
"Section 12.5.8. Detecting and recording adverse events, serious adverse events and pregnancies",
"Section 12.5.8.2.1. Active questioning to detect adverse events and serious adverse events",
"Section 12.5.8.2.2. Assessment o... |
NCT04420221 | 208833 | (STAPH AUREUS BIOCONJ-001 STG) Protocol Amendment 6 Final | | Adults | | |
|---------------|-----------------|-------------------------------------------|
| Adverse Event | Intensity grade | Parameter |
| | 2 | Moderate: Interferes with daily activity |
... | [
"Signature Page for 208833 TMF-15034175 v1.0"
] |
NCT04535986 | 1.0 | PROTOCOL SUMMARY | [] | |
NCT04535986 | 1.1 | Synopsis |
A Phase III Randomized. Double-Blind. Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine over 24 Weeks (With a 48-Week Safety Subset) in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease.
A Phase III randomized. placebo-controlled study to evaluate the efficacy and safe... | [
"Protocol Title:",
"Short Title:",
"Rationale",
"Objectives and Endpoints",
"Objectives",
"Primary Objective",
"Secondary Objectives",
"Other Objectives",
"Safety Objective",
"Endpoints",
"Primary Endpoint",
"Secondary Endpoints",
"Other Endpoints",
"Safety Endpoints",
"Overall Design",
... |
NCT04535986 | 2.0 | INTRODUCTION | [] | |
NCT04535986 | 2.1 | Study Rationale | Verona Pharma plc. is developing inhaled nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD). RPL554-CO-301 is one of the two Phase III confirmatory studies for the inhaled nebulized ensifentrine suspension formulation in patients with COPD.
The two confirmatory studies... | [] |
NCT04535986 | 2.2 | Background | Ensifentrine is a selective dual phosphodiesterase (PDE)3 and PDE4 inhibitor which has clinically demonstrated bronchodilation and anti-inflammatory activity following inhaled dosing. This novel mechanism of action represents an important potential additional treatment option for patients with moderate to severe COPD. ... | [] |
NCT04535986 | 2.3 | Benefit/Risk Assessment | No significant medical risks to patients have been identified from studies conducted thus far with ensifentrine administered in the solution formulation. suspension formulation. or dry powder formulation. A slight increase in mean heart rate (up to 12 beats per minute [bpm]) without reported medical significance at a 6... | [] |
NCT04535986 | 3.0 | OBJECTIVES AND ENDPOINTS | [] | |
NCT04535986 | 3.1 | Objectives | [] | |
NCT04535986 | 3.1.1 | Primary Objective | The primary objective of this study is to evaluate the efficacy of ensifentrine on lung function compared to placebo over a 12-hour dosing interval in patients with moderate to severe COPD. | [] |
NCT04535986 | 3.1.2 | Secondary Objectives | - ® To evaluate the effect of ensifentrine on other lung function parameters. = To evaluate the effect of ensifentrine on COPD symptoms.
- = To evaluate the effect of ensifentrine on health-related quality of life. | [] |
NCT04535986 | 3.1.3 | Other Objectives | - \* To evaluate the effect of ensifentrine on moderate/severe COPD exacerbations. \* To evaluate the effect of ensifentrine on health utility and healthcare resource
- utilization (HRU). | [] |
NCT04535986 | 3.1.4 | Safety Objective | To evaluate the safety and tolerability of ensifentrine over 24 and 48 Weeks. | [] |
NCT04535986 | 3.2 | Endpoints | [] | |
NCT04535986 | 3.2.1 | Primary Endpoint | Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)o-12u post-dose at Week 12 (change from baseline). | [] |
NCT04535986 | 3.2.2 | Secondary Endpoints | - \* Peak FEV;over 4 hours post-dose at Week 12 (change from baseline).
- \* Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24 (change from baseline as a weekly average). Verona Pharma plc CONFIDENTIAL Page 50 of 135
- \* SGRQ total score at Week 24 (change from baseline).
- \* Morning trough FEV) at We... | [] |
NCT04535986 | 3.2.3 | Other Endpoints | - \* Moderate/severe COPD exacerbation frequency over 24 and 48 Weeks (this individual study and pooled with data from study RPL554-CO-302).
- \* Time to first moderate/severe COPD exacerbation over 24 and 48 Weeks (this individual study and pooled with data from study RPL554-CO-302).
- s Smdy withdrawal before 24 and ... | [] |
NCT04535986 | 3.2.4 | Safety Endpoints | - \* Incidence of AEs
- = Vital signs
- s Electrocardiogram (ECG)
- = Laboratory tests
Verona Pharma plc CONFIDENTIAL Page 51 of 135 | [] |
NCT04535986 | 4.0 | STUDY DESIGN | [] | |
NCT04535986 | 4.1 | Overall Design | RPL554-CO-301 is a multicenter, randomized. double blind. parallel group, placebo controlled study to determine the efficacy and safety of ensifentrine 3 mg twice daily (BID) for 24 weeks with a subset of patients for 48 weeks. administered via nebulizer vs. placebo in patients 40 to 80 years of age with moderate to se... | [] |
NCT04535986 | 4.2 | Scientific Rationale for Study Design | Verona Pharma plc is developing inhaled nebulized ensifentrine for the maintenance treatment of COPD. RPL554-C0O-301 is one of the two Phase III confirmatory studies for the inhaled nebulized ensifentrine suspension formulation in patients with COPD.
The two confirmatory studies RPL554-CO-301 and RPL554-CO-302 are pla... | [] |
NCT04535986 | 4.3 | Justification for Dose | A 3 mg twice daily dose was selected as the Phase 3 dose based on data from two 4-week Phase IIb studies RPL554-C0-203 and RPL554-C0O-205 which show clinically meaningful and statistically significant improvements in pulmonary function with the 3 mg dose over the 12-hour dosing interval. in patients with or without add... | [] |
NCT04535986 | 4.4 | End of Study Definition | A patient is considered to have completed the study if he/she has successfully completed all on-treatment randomized visits and completed follow-up contact.
The end of the study is defined as the date of the last follow-up contact of the last patient in the study.
Verona Pharma plc CONFIDENTIAL Page 55 of 135 | [] |
NCT04535986 | 5.0 | STUDY POPULATION | Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions. is not permitted. | [] |
NCT04535986 | 5.1 | Inclusion Criteria |
1. Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this profocol.
- 2. Age: Patient must be 40 to 80 years of age inclusive, at the time of Scre... | [
"Informed Consent",
"Age and Sex",
"Smoking History",
"COPD Diagnosis, Symptoms, Severity and Maintenance Therapy"
] |
NCT04535986 | 7 | COPD Severity: | - a. Pre- and Post-albuterol/salbutamol FEV/FVC ratio of <0.70.
- b. Post-albuterol/salbutamol FEV1 =30 % and <70% of predicted normal calculated using the National Health and Nutrition Examination Survey IIT (Hankinson. 1999).
- 8. Maintenance Therapy: Patients on no maintenance/background therapy or patients on stabl... | [
"Other Requirements for Inclusion",
"5.2 Exclusion Criteria",
"Current Condition or Medical History",
"Prior/Concomitant Therapy",
"History or Suspicion of Drug or Alcohol Abuse",
"Laboratory and Other Diagnostic Paramelers",
"Other Exclusions",
"5.3 Randomization Criteria",
"Criteria for Inclusion ... |
NCT04535986 | 551 | Rescreening Prohibited | Patients who do not meet the following Inclusion Criteria may not be rescreened under any circumstances:
- \* Inclusion Criteria #5: COPD Diagnosis \* Inclusion Criteria #6: COPD Symptoms
- \* Inclusion Criteria #7: COPD Severity | [] |
NCT04535986 | 552 | Rescreening Permitted if Medical Monitor Approves | Approval from the Medical Monitor must be obtained to rescreen patients other than those for whom rescreening is prohibited (Section 5.5.1). Rescreened patients should be assigned the same patient number as for the initial Screening.
Screen failures are defined as patients who consent to participate in the clinical st... | [
"5.6 Screen Failures",
"6.0 STUDY TREATMENT",
"6.1 Administration of Blinded Study Medication",
"6.1.1 Deosing in the Clinic",
"Dosing Environment",
"Designated Unblinded Site Staff Member",
"Dosing Visit Schedule and Time(s) of Day",
"Blinded Study Medication Administration",
"6.1.2 Deosing at Home... |
NCT04761133 | 1.0 | Background | Pleural infection is a condition that requires hospitalization for management and is associated with significant in-hospital morbidity and mortality[1]. Predictors of poor outcome include advancing age, poor nutrition, hospital-acquired infection and impaired renal function.[2] Medical management is centred on appropri... | [] |
NCT04761133 | 2.0 | Methods |
*PICS STUDY*
The Pleural Infection Cohort Study (PICS) will aim to recruit consecutive patients admitted to Alexandria University Hospitals with pleural infection during a one-year period from the starting date of the study. | [
"PICS STUDY",
"2.1.1Setting"
] |
NCT04761133 | 2.1.2 | Design | The study will be designed as a modified trial within cohort (TwiC) study.[5] PICS will primarily aim to recruit patients prospectively to gather clinical and demographic data on patients admitted with pleural infection in addition to clinical data on tests performed and treatments received as part of the standard care... | [] |
NCT04761133 | 2.1.3 | Eligibility | All adult patients admitted with pleural infection who are willing to sign an informed consent will be recruited. Pleural infection will be defined by the presence of one of the following: a) the presence of pus in the pleural space; b) positive pleural fluid gram stain or culture; or c) pleural fluid pH < 7.2 or pleur... | [] |
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