protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03907969 | 12.2 | Scientific rationale for study design | 12.2 Scientific rationale for study design   | [] |
NCT03907969 | 12.3 | Justification for dose | 12.3 Justification for dose | [] |
NCT03907969 | 12.3.1 | Justification for AZD7648 dose | 12.3.1 Justification for AZD7648 dose The actual starting dose of AZD7648 for this module will be dependent on clinical PK exposure and emerging safety and tolerability data seen during the monotherapy escalation (refer to the Core Module). However, the actual AZD7648 starting dose will be triggered when the equivalent... | [] |
NCT03907969 | 12.3.2 | Justification for pegylated liposomal doxorubicin dose | 12.3.2 Justification for pegylated liposomal doxorubicin dose Although PLD is approved at a dose of 50 mg/m2 every 4 weeks, it is common for patients to require a dose reduction to 40 mg/m2 due to AEs such as palmar-plantar erythrodysesthesia, stomatitis or haematological toxicity. Several large studies including combi... | [] |
NCT03907969 | 13 | STUDY POPULATION | 13 STUDY POPULATION | [] |
NCT03907969 | 13.1 | Inclusion criteria | 13.1 Inclusion criteria Patients are eligible to be included in the study only if all the inclusion criteria apply. Please also refer to Section 5.1 for the inclusion criteria applicable to all modules in the study. If the criteria in the modules is different from that in the Core Module criteria, the module-specific c... | [
"Part A and B",
"Part B only"
] |
NCT03907969 | 13.2 | Exclusion criteria | 13.2 Exclusion criteria Patients must not enter Combination Module 1 of the study if any of the exclusion criteria apply. Please also refer to Section 5.2 for the exclusion criteria applicable to all modules in the study. If the criteria in the modules is different from that in the Core Module criteria, the module-spec... | [
"Part A and B",
"Part B only"
] |
NCT03907969 | 13.3 | Lifestyle restrictions | 13.3 Lifestyle restrictions Restrictions for PLD should follow the institutional guidelines. Please refer to Appendix G for contraception restrictions. | [] |
NCT03907969 | 14 | STUDY TREATMENTS | 14 STUDY TREATMENTS Study treatment in Combination Module 1 refers to AZD7648 and PLD (Table 14). | [] |
NCT03907969 | 14.1 | Treatments administered | 14.1 Treatments administered | [] |
NCT03907969 | 14.1.1 | Investigational products | 14.1.1 Investigational products Table 14 Study treatments | Study treatmentname: | AZD7648 | Pegylated liposomaldoxorubicin | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03907969 | 14.1.2 | Dose escalation scheme | 14.1.2 Dose escalation scheme For Combination Module 1, the dose escalation schedule is presented in Figure 9. When there is more than one patient enrolled to a dose cohort, sentinel dosing will be applied with a single patient exposed for a minimum of 48 hours after Cycle 1, Day 1 before further patients are enrolled ... | [] |
NCT03907969 | 14.2 | Treatment compliance | 14.2 Treatment compliance PLD will be administered on site and will be recorded in the appropriate section of the CRF. | [] |
NCT03907969 | 14.3 | Concomitant therapy | 14.3 Concomitant therapy | [] |
NCT03907969 | 14.3.1 | Effect of pegylated liposomal doxorubicin on other drugs | 14.3.1 Effect of pegylated liposomal doxorubicin on other drugs No formal medicinal product interaction studies have been performed with PLD, although Phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological malignancies. Exercise caution in the concomitant u... | [] |
NCT03907969 | 14.4 | Dose modification | 14.4 Dose modification Refer to Section 6.6 for management of treatment related toxicity applicable to all study modules. If the toxicity does not resolve to the patient's baseline or to CTCAE Grade ≤ 2 within 28 days of onset, treatment with AZD7648 and PLD must be discontinued. However, if toxicity is clearly attribu... | [] |
NCT03907969 | 15 | STUDY ASSESSMENTS AND PROCEDURES | 15 STUDY ASSESSMENTS AND PROCEDURES Study procedures and their timing are summarised in the SoA (Table 13). | [] |
NCT03907969 | 15.1 | Management of study treatment-related toxicities | 15.1 Management of study treatment-related toxicities At this time, there are limited safety data regarding the combination of AZD7648 and PLD. Given the differing mechanisms of action of AZD7648 and PLD, the potential for potentiation of toxicities is thought to be limited. Some toxicities, for example pneumonitis and... | [] |
NCT03907969 | 15.2 | Echocardiogram | 15.2 Echocardiogram An echocardiogram or MUGA scan will be conducted on all patients at screening for Parts A and B, and at the timepoints in the SoA (Table 13). The screening echocardiogram or MUGA scan will not be required if a previous echocardiogram or MUGA scan was performed 6 months prior to screening, unless the... | [] |
NCT03907969 | 15.3 | Pharmacokinetics | 15.3 Pharmacokinetics Venous blood samples (2 mL) for determination of concentrations of PLD (as total doxorubicin), will be taken at the times presented in the SoA (Table 13) in addition to the venous blood samples (2 mL) for determination of concentrations of AZD7648 in plasma. The date and time of collection of each... | [] |
NCT03907969 | 15.4 | Pharmacodynamics | 15.4 Pharmacodynamics Refer to Section 8.6.1 for further details which also apply to this Module. Peripheral blood samples will be collected 4 hours after the start of the PLD infusion and 2 to 4 hours post-dose for AZD7648 as detailed in Table 17 and the SoAs. In addition, there will be PK samples collected at the sam... | [] |
NCT03907969 | 16 | STATISTICAL CONSIDERATIONS | 16 STATISTICAL CONSIDERATIONS | [] |
NCT03907969 | 16.1 | Interim analysis | 16.1 Interim analysis One interim analysis is planned during Part B of the study, as described in . Table 18 Interim analysis | Drug combination (module) | Population | TV% | LRV% | Samplesize (N) | Interim(n) | |---------------------------|-----------------------------|-----|------|--------------------|---------------... | [] |
NCT03907969 | 16.2 | Sample size determination | 16.2 Sample size determination Part A will require approximately 30 evaluable patients across approximately 5 cohorts (n = 3 to 6 per cohort) to provide a model-based estimate of MTD within target toxicity (30%). Once MTD has been determined, an additional 30 evaluable patients may be recruited to investigate intermitt... | [] |
NCT03907969 | 17 | REFERENCES | 17 REFERENCES
Beskow et al 2009 Beskow C, Skikuniene J, Holgersson A, Nilsson B, Lewensohn R, Kanter L, et al. Radioresistant cervical cancer shows upregulation of the NHEJ proteins DNA-PKcs, Ku70 and Ku86. Br J Cancer. 2009; 101(5): 816-21.
Blunt et al 1995 Blunt T, Finnie NJ, Taccioli GE, Smith GC, Demengeot J, Got... | [
"Beskow et al 2009",
"Blunt et al 1995",
"Chan et al 2002",
"Dietlein et al 2014",
"Dolman et al 2015",
"Goodwin and Knudsen 2014",
"Graham et al 2016",
"Gurley et al 2001",
"Hartlerode and Scully 2009",
"Hosoi et al 2004",
"Jackson et al 1993",
"Neal and Meek 2011",
"NCCN 2011",
"O'Connor... |
NCT03907969 | 18 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS | 18 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
Appendix A Regulatory, Ethical and Study Oversight Considerations | [
"Appendix A Regulatory, Ethical and Study Oversight Considerations"
] |
NCT03907969 | A | 1 Regulatory and ethical considerations | A 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) International ... | [] |
NCT03907969 | A | 2 Financial disclosure | A 2 Financial disclosure Investigators and sub-Investigators will provide the Sponsor with sufficient, accurate financial information as requested to allow the Sponsor to submit complete and accurate financial certification or disclosure statements to the appropriate Regulatory authorities. Investigators are responsibl... | [] |
NCT03907969 | A | 3 Informed consent process | A 3 Informed consent process The Investigator or his/her representative will explain the nature of the study to the patient or his/her legally authorised representative and answer all questions regarding the study. Patients must be informed that their participation is voluntary. Patients or their legally authorised rep... | [] |
NCT03907969 | A | 4 Data protection | A 4 Data protection Each patient will be assigned a unique identifier by the Sponsor. Any patient records or data sets transferred to the Sponsor will contain only the identifier; patient names or any information which would make the patient identifiable will not be transferred. The patient must be informed that his/he... | [] |
NCT03907969 | A | 5 Committees structure | A 5 Committees structure No Data Monitoring Committee will be used in this study; however a safety review committee (SRC) will closely monitor patient safety on an ongoing basis. The SRC Members will include the following: - Principal Investigator, or delegate, who will chair the committee - Study Chair (if not Princip... | [] |
NCT03907969 | A | 6 Dissemination of clinical study data | A 6 Dissemination of clinical study data A description of this clinical trial will be available on https://astrazenecagrouptrials.pharmacm.com and http://www.clinicaltrials.gov as will the summary of the main study results when they are available. The clinical trial and/or summary of main study results may also be avai... | [] |
NCT03907969 | A | 7 Data quality assurance | A 7 Data quality assurance All patient data relating to the study will be recorded on printed or electronic case report form (CRF) 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... | [] |
NCT03907969 | A | 8 Source documents | A 8 Source documents Source documents provide evidence for the existence of the patient and substantiate the integrity of the data collected. Source documents are filed at the Investigator's site. Data reported on the CRF that are transcribed from source documents must be consistent with the source documents or the dis... | [] |
NCT03907969 | A | 9 Study and site closure | A 9 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... | [] |
NCT03907969 | A | 10 Publication policy | A 10 Publication policy The results of this study may be published or presented at scientific meetings. If this is foreseen, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. The Sponsor wi... | [
"Appendix B Adverse Event Definitions and Additional Safety Information"
] |
NCT03907969 | B | 1 Definition of adverse events | B 1 Definition of adverse events An adverse event (AE) is the development of any untoward medical occurrence in a patient or clinical study patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign ... | [] |
NCT03907969 | B | 2 Definitions of serious adverse event | B 2 Definitions of serious adverse event A serious adverse event (SAE) is an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: - Results in death - Is immediately life-threatening - Requires in-patient hospitalisation or prolongation of ... | [] |
NCT03907969 | B | 3 Life threatening | B 3 Life threatening 'Life-threatening' means that the patient was at immediate risk of death from the AE as it occurred or it is suspected that use or continued use of the product would result in the patient's death. 'Life-threatening' does not mean that had an AE occurred in a more severe form it might have caused de... | [] |
NCT03907969 | B | 4 Hospitalisation | B 4 Hospitalisation Outpatient treatment in an emergency room is not in itself a SAE, although the reasons for it may be (eg, bronchospasm, laryngeal oedema). Hospital admissions and/or surgical operations planned before or during a study are not considered AEs if the illness or disease existed before the patient was e... | [] |
NCT03907969 | B | 5 Important medical event or medical treatment | B 5 Important medical event or medical treatment Medical and scientific judgement should be exercised in deciding whether a case is serious in situations where important medical events may not be immediately life-threatening or result in death, hospitalisation, disability or incapacity but may jeopardise the patient or... | [] |
NCT03907969 | B | 6 Intensity rating scale: | B 6 Intensity rating scale: The grading scales found in the revised National Cancer Institute common terminology criteria for adverse event (CTCAE) version 5.0 will be utilised for all events with an assigned CTCAE grading. For those events without assigned CTCAE grades, the recommendation in the CTCAE criteria that co... | [] |
NCT03907969 | B | 7 A Guide to Interpreting the Causality Question | B 7 A Guide to Interpreting the Causality Question When making an assessment of causality consider the following factors when deciding if there is a 'reasonable possibility' that an AE may have been caused by the drug. - Time Course. Exposure to suspect drug. Has the patient actually received the suspect drug? Did the ... | [] |
NCT03907969 | B | 8 Medication Error | B 8 Medication Error For the purposes of this clinical study a medication error is an unintended failure or mistake in the treatment process for an AstraZeneca study treatment that either causes harm to the participant or has the potential to cause harm to the participant. A medication error is not lack of efficacy of ... | [
"Appendix C Handling of Human Biological Samples"
] |
NCT03907969 | C | 1 Chain of custody of biological samples | C 1 Chain of custody of biological samples A full chain of custody is maintained for all samples throughout their life cycle. The Investigator at each centre keeps full traceability of collected biological samples from the patients whilst in storage at the centre until shipment or disposal (where appropriate). The samp... | [] |
NCT03907969 | C | 2 Withdrawal of Informed Consent for donated biological samples | C 2 Withdrawal of Informed Consent for donated biological samples If a patient withdraws consent to the use of donated biological samples, the samples will be disposed of/destroyed, and the action documented. If samples are already analysed, AstraZeneca is not obliged to destroy the results of this research.
The Inves... | [
"The Investigator:"
] |
NCT03907969 | C | 3 International Airline Transportation Association (IATA) 6.2 Guidance Document | C 3 International Airline Transportation Association (IATA) 6.2 Guidance Document
LABELLING AND SHIPMENT OF BIOHAZARD SAMPLES International Airline Transportation Association (IATA) classifies biohazardous agents into 3 categories (http://www.iata.org/whatwedo/cargo/dangerous\goods/infectious\substances.htm). For tran... | [
"LABELLING AND SHIPMENT OF BIOHAZARD SAMPLES",
"Appendix D Genetics"
] |
NCT03907969 | D | 1 Use/analysis of DNA | D 1 Use/analysis of DNA Genetic variation may impact a patient's response to therapy, susceptibility to, and severity and progression of disease. Variable response to therapy may be due to genetic determinants that impact drug absorption, distribution, metabolism, and excretion; mechanism of action of the drug; disease... | [] |
NCT03907969 | D | 2 Genetic research plan and procedures | D 2 Genetic research plan and procedures
Selection of Genetic Research Population
Study Selection Record All patients will be asked to participate in this genetic research. Participation is voluntary and if a patient declines to participate there will be no penalty or loss of benefit. The patient will not be excluded... | [
"Selection of Genetic Research Population",
"Study Selection Record",
"Inclusion Criteria",
"Exclusion Criteria",
"Withdrawal of Consent for Genetic Research:",
"Collection of Samples for Genetic Research",
"Coding and Storage of DNA Samples",
"Ethical and Regulatory Requirements",
"Informed Consent... |
NCT03907969 | E | 1 Introduction | E 1 Introduction This Appendix describes the process to be followed in order to identify and appropriately report Potential Hy's Law (PHL) cases and Hy's Law (HL) cases. It is not intended to be a comprehensive guide to the management of elevated liver biochemistries. During the course of the study the Investigator wil... | [] |
NCT03907969 | E | 2 Definitions | E 2 Definitions
Potential Hy's Law (PHL) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3× ULN together with total bilirubin (TBL) ≥ 2×ULN at any point during the study following the start of study treatment, irrespective of an increase in alkaline phosphatase (ALP).
Hy's Law (HL) AST or ALT ≥ 3... | [
"Potential Hy's Law (PHL)",
"Hy's Law (HL)"
] |
NCT03907969 | E | 3 Identification of potential Hy's Law cases | E 3 Identification of potential Hy's Law cases In order to identify cases of PHL it is important to perform a comprehensive review of laboratory data for any patient who meets any of the following identification criteria in isolation or in combination: - ALT ≥ 3 × ULN - AST ≥ 3 × ULN - TBL ≥ 2 × ULN The Investigator wi... | [] |
NCT03907969 | E | 4 Follow-up | E 4 Follow-up | [] |
NCT03907969 | E | 4.1 Potential Hy's Law criteria not met | E 4.1 Potential Hy's Law criteria not met If the patient does not meet PHL criteria the Investigator will: Perform follow-up on subsequent laboratory results according to the guidance provided in the CSP. | [] |
NCT03907969 | E | 4.2 Potential Hy's Law criteria met | E 4.2 Potential Hy's Law criteria met If the patient does meet PHL criteria the Investigator will: - Determine whether PHL criteria were met at any study visit prior to starting study treatment (See Appendix E, Section 6. Actions Required When Potential Hy's Law Criteria are Met Before and After Starting Study Treatmen... | [] |
NCT03907969 | E | 5 Review and assessment of potential Hy's Law cases | E 5 Review and assessment of potential Hy's Law cases The instructions in this section should be followed for all cases where PHL criteria are met. As soon as possible after the biochemistry abnormality was initially detected, the study Physician contacts the Investigator in order to review available data and agree on ... | [] |
NCT03907969 | E | 6 Actions required when potential Hy's Law criteria are met before and after starting study treatment | E 6 Actions required when potential Hy's Law criteria are met before and after starting study treatment This section is applicable to patients with liver metastases who meet PHL criteria on study treatment having previously met PHL criteria at a study visit prior to starting study treatment. At the first on-study treat... | [
"A 'significant' change in the patient's condition refers to a clinically relevant change in any of the individual liver biochemistry parameters (ALT, AST or TBL) in isolation or in combination, or a clinically relevant change in associated symptoms. The determination of whether there has been a significant change ... |
NCT03907969 | E | 7 Actions required for repeat episodes of potential Hy's Law | E 7 Actions required for repeat episodes of potential Hy's Law This section is applicable when a patient meets PHL criteria on study treatment and has already met PHL criteria at a previous on study treatment visit. The requirement to conduct follow-up, review, and assessment of a repeat occurrence(s) of PHL is based o... | [
"A 'significant' change in the patient's condition refers to a clinically relevant change in any of the individual liver biochemistry parameters (ALT, AST or TBL) in isolation or in combination, or a clinically relevant change in associated symptoms. The determination of whether there has been a significant change ... |
NCT03907969 | F | 1 Restrictions regarding drugs affecting CYP3A4 | F 1 Restrictions regarding drugs affecting CYP3A4 There are currently no data confirming that there is a pharmacokinetic interaction between these agents and AZD7648; any potential interaction is considered on the basis of preclinical and in vitro human data only. The principal enzymes for metabolising AZD7648 are CYP3... | [
"Potent CYP3A4 inhibitors may increase exposure to AZD7648 boceprevir clarithromycin conivaptan elvitegravir/ritonivir fluconazole grapefruit juiceab indinavir itraconazole ketoconazole lopinavir/ RIT mibefradil nefazodone nelfinavir posaconazole ritonavir saquinavir telaprevir telithromycin tipranavir/ ritonivir t... |
NCT03907969 | J | 1 Reconsent of Study Patients During Study Interruptions | J 1 Reconsent of Study Patients During Study Interruptions During study interruptions, it may not be possible for the patients to complete study visits and assessments on site and alternative means for carrying out the visits and assessments may be necessary, eg, remote visits. Reconsent should be obtained for the alte... | [] |
NCT03907969 | J | 2 Rescreening of Patients To Reconfirm Study Eligibility | J 2 Rescreening of Patients To Reconfirm Study Eligibility Additional rescreening for screen failure due to study disruption can be performed in previously screened participants. The investigator should confirm this with the designated study physician. In addition, during study disruption there may be a delay between c... | [] |
NCT03907969 | J | 3 Home or Remote Visit to Replace On-site Visit (where applicable) | J 3 Home or Remote Visit to Replace On-site Visit (where applicable) A qualified Health Care Professional (HCP) from the study site or third-party vendor service will visit the patients home / or other remote location as per local standard operating procedures (SOPs), as applicable. Supplies will be provided for a safe... | [] |
NCT03907969 | J | 4 Telemedicine Visit to Replace On-site Visit (where applicable) | J 4 Telemedicine Visit to Replace On-site Visit (where applicable) In this appendix, the term telemedicine visit refers to remote contact with the patients using telecommunications technology including phone calls, virtual or video visits, and mobile health devices. During a civil crisis, natural disaster, or public he... | [] |
NCT03907969 | J | 5 At-home or Remote Location IP Administration Instructions | J 5 At-home or Remote Location IP Administration Instructions If a site visit is not possible, at-home or remote location administration of investigational product may be performed by a qualified HCP, provided this is acceptable within local regulation/guidance, or by the patient or his/her caregiver. The option of at-... | [] |
NCT03907969 | J | 6 Data Capture During Telemedicine or Home / Remote Visits | J 6 Data Capture During Telemedicine or Home / Remote Visits Data collected during telemedicine or home / remote visits will be captured by the qualified HCP from the study site or third-party vendor service, or by the patient themselves eg, details of self-administration of study medication in diary card.
Appendix K ... | [
"Appendix K Abbreviations",
"SIGNATURE PAGE"
] |
NCT03911401 | 1 | Introduction | 1 Introduction Atopic dermatitis (AD) is defined as "a disease with repeated exacerbations/remissions of which the main lesion is eczema with pruritus, and most patients have atopic predisposition. Atopic predisposition means 1) having a family history/medical history (one or more diseases of bronchial asthma, allergic... | [] |
NCT03911401 | 1.1 | Nonclinical Study Results | 1.1 Nonclinical Study Results OPA-15406 had potent and selective PDE4 inhibitory actions, especially against PDE4B, and its 50% inhibitory concentration was 0.0112 μM. Using a mouse chronic contact hypersensitivity model as an animal model of AD, the dose-dependent efficacy of the OPA-15406 ointment (0.03% - 3%) for ch... | [] |
NCT03911401 | 1.2 | Clinical Study Results | 1.2 Clinical Study Results Phase 2 trials in AD patients have been completed both in Japan and outside Japan. For further information, refer to the Investigator's Brochure. | [] |
NCT03911401 | 1.2.1 | Phase 1 Trial in Healthy Adult Subjects in the United States (Trial 271-11-202) | 1.2.1 Phase 1 Trial in Healthy Adult Subjects in the United States (Trial 271-11-202) In the phase 1 trial in healthy adult subjects (aged 18 - 64 years old) in the US, side-by-side comparison was performed on the back of the subject using the vehicle of OPA-15406 ointment (placebo) as the control. The dose was escalat... | [] |
NCT03911401 | 1.2.2 | Phase 1 Trial in Healthy Adult Male Subjects in Japan (Trial 271-14-001) | 1.2.2 Phase 1 Trial in Healthy Adult Male Subjects in Japan (Trial 271-14-001) In the phase 1 trial in healthy adult male subjects (aged 20 - 40 years old) in Japan, a single-dose or 2-week twice-daily multiple doses of the 0.3%, 1%, or 3% OPA-15406 ointment (8 subjects for each group) or the vehicle of OPA-15406 ointm... | [] |
NCT03911401 | 1.2.3 | Trial for Phototoxicity in Healthy Adult Subjects in the United States (Trial 271-12-212) | 1.2.3 Trial for Phototoxicity in Healthy Adult Subjects in the United States (Trial 271-12-212) In the trial for phototoxicity in 40 healthy adult subjects in the US, the phototoxicity was evaluated by a single administration of 0.3%, 1%, or 3% formulation of OPA-15406 ointment or the corresponding vehicle (placebo) on... | [] |
NCT03911401 | 1.2.4 | Trial for Photoallergy in Healthy Adult Subjects in the United States (Trial 271-12-213) | 1.2.4 Trial for Photoallergy in Healthy Adult Subjects in the United States (Trial 271-12-213) In the trial for photoallergy in 62 healthy adult subjects in the US, photoallergy was evaluated by multiple administrations of 0.3%, 1%, or 3% formulation of OPA-15406 ointment or the corresponding vehicle (placebo) on the b... | [] |
NCT03911401 | 1.2.5 | Phase 1 Trial in Atopic Dermatitis Patients in the United States (Trial 271-12-204) | 1.2.5 Phase 1 Trial in Atopic Dermatitis Patients in the United States (Trial 271-12-204) In the phase 1 trial in AD patients (aged 18 - 65 years old) in the US, 0.3%, 1%, or 3% formulation of OPA-15406 ointment (15 subjects for each group) or the vehicle of OPA-15406 ointment (placebo) as the control were administered... | [] |
NCT03911401 | 1.2.6 | Phase 2 Trial in Atopic Dermatitis Patients Outside Japan (Trial 271-12-205) | 1.2.6 Phase 2 Trial in Atopic Dermatitis Patients Outside Japan (Trial 271-12-205) In the phase 2 trial in AD patients (aged 10 - 70 years old) outside Japan, the efficacy, safety, and tolerability of the 8-week twice-daily multiple doses of OPA-15406 ointment was investigated by selecting 0.3% and 1% formulations (40 ... | [] |
NCT03911401 | 1.2.7 | Pharmacokinetic Phase 2 Trial in Atopic Dermatitis Patients Outside Japan (Trial MEDI-MM 36-206) | 1.2.7 Pharmacokinetic Phase 2 Trial in Atopic Dermatitis Patients Outside Japan (Trial MEDI-MM 36-206) In the pharmacokinetic phase 2 trial in pediatric AD patients (aged 2 - 17 years old) outside Japan, 1% OPA-15406 ointment was administered twice daily for 4 weeks in subjects aged 2 to 11 years old with affected BSA ... | [] |
NCT03911401 | 1.2.8 | Phase 2 Trial in Adult Atopic Dermatitis Patients in Japan (Trial 271-15-001) | 1.2.8 Phase 2 Trial in Adult Atopic Dermatitis Patients in Japan (Trial 271-15-001) In the phase 2 trial in AD patients (aged 15 - 70 years old) in Japan, the efficacy, safety, and pharmacokinetics of the 8-week twice-daily multiple doses of the 0.3% or 1% OPA-15406 ointment (60 subjects for each group) were investigat... | [] |
NCT03911401 | 1.2.9 | Phase 2 Trial in Pediatric Atopic Dermatitis Patients in Japan (Trial 271-102-00002) | 1.2.9 Phase 2 Trial in Pediatric Atopic Dermatitis Patients in Japan (Trial 271-102-00002) In the phase 2 trial in AD patients (aged 2 - 14 years old) in Japan, the safety, efficacy, and pharmacokinetics of the 4-week twice-daily multiple doses of the OPA-15406 ointment were investigated by selecting 0.3% and 1% formul... | [] |
NCT03911401 | 1.3 | Known and Potential Risks and Benefits | 1.3 Known and Potential Risks and Benefits As of the data cutoff date (18 Feb 2018), in the phase 1 trial in healthy adults in the US (Trial 271-11-202), the trial for phototoxicity in the US (Trial 271-12-212), the trial for photoallergy in the US (Trial 271-12-213), the phase 1 trial in healthy adult male subjects in... | [] |
NCT03911401 | 2 | Trial Rationale and Objectives | 2 Trial Rationale and Objectives | [] |
NCT03911401 | 2.1 | Trial Rationale | 2.1 Trial Rationale In the phase 2 trial in pediatric AD patients in Japan (Trial 271-102-00002), which were conducted prior to the present trial, the safety, efficacy, and tolerability of the 4-week twice-daily multiple doses of the 0.3% or 1% OPA-15406 ointment or the vehicle (placebo) were investigated. There were n... | [] |
NCT03911401 | 2.2 | Dosing Rationale | 2.2 Dosing Rationale Skin preparations are always exposed to opportunities of being removed after administration to the skin, such opportunities as washing the face, bathing, adhesion to clothing, or sweating resulting in dilution. To be sure that effective concentration on the skin is maintained, it is desirable that ... | [] |
NCT03911401 | 2.3 | Rationale for Severity and Age Setting | 2.3 Rationale for Severity and Age Setting Atopic dermatitis is mainly treated with topical drugs. However, for severe patients, oral agents and ultraviolet therapy are often combined due to inadequate response to topical drugs alone. Thus, the phase 2 trials in Japan (Trials 271-15-001 and 271-102-00002) were conducte... | [] |
NCT03911401 | 2.4 | Trial Objectives | 2.4 Trial Objectives Primary Objective: To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in IGA at Week 4 as the primary endpoint in pediatric patients wit... | [] |
NCT03911401 | 3 | Trial Design | 3 Trial Design | [] |
NCT03911401 | 3.1 | Type/Design of Trial | 3.1 Type/Design of Trial This trial is a multicenter, randomized, double-blind, vehicle-controlled, parallel group, comparison trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to the vehicle in pediatric AD patients. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the ... | [
"1) Screening period",
"2) Assessment period (treatment period)",
"3) Trial period"
] |
NCT03911401 | 3.2 | Methods of Administration | 3.2 Methods of Administration | [] |
NCT03911401 | 3.2.1 | Dose, Regimen, and Treatment Period | 3.2.1 Dose, Regimen, and Treatment Period The 0.3% or 1% formulation or the vehicle of OPA-15406 ointment will be administered twice daily (approximately 12 hours apart between morning and night administration) for 4 weeks. The amount of IMP (g) per dose is 10 g/m2 BSA and calculated as follows. 1) The subject's BSA (m... | [
"[Rationale for treatment period]"
] |
NCT03911401 | 3.2.2 | Treatment Area | 3.2.2 Treatment Area The treatment area with the IMP is defined as follows. - The treatment area selected at baseline examination will be affected area determined at baseline examination (see [Section](#page-50-0) [3.7.5.5](#page-50-0), [Affected Body Surface Area](#page-50-0)). - After the baseline examination, when t... | [] |
NCT03911401 | 3.3 | Trial Population | 3.3 Trial Population | [] |
NCT03911401 | 3.3.1 | Number of Subjects and Description of Population | 3.3.1 Number of Subjects and Description of Population The target population of this trial is pediatric AD patient with an IGA score of 2 or 3. Subjects will be included in the trial to reach the target number of 240 subjects for IMP administration (the target inclusion ratio for "2 - 6 years old" and "7 - 14 years old... | [] |
NCT03911401 | 3.3.2 | Issue of Subject Identification Number | 3.3.2 Issue of Subject Identification Number A subject identification number ([3 digit number of site ID] + subject number [S + 5 digit number]) will be assigned to the subject providing written informed consent. The sponsor will provide the trial site number. The subject number will be a serial number assigned at the ... | [] |
NCT03911401 | 3.4 | Eligibility Criteria | 3.4 Eligibility Criteria | [] |
NCT03911401 | 3.4.1 | Informed Consent | 3.4.1 Informed Consent Freely given written informed consent will be obtained from the subject's legal guardian (guardians or legal representatives, as applicable by law) instead of the subject. The relationship between the subject and the subject's legal guardian will be confirmed and recorded. If possible, assent (co... | [] |
NCT03911401 | 3.4.2 | Inclusion Criteria | 3.4.2 Inclusion Criteria Subjects are required to meet the following inclusion criteria #1 through #7 in [Table](#page-35-0) [3.4.2-1](#page-35-0) at the screening examination, and #6 and #7 at the screening examination and the baseline examination. | | Table 3.4.2-1Inclusion Criteria | |---|---------------------------... | [
"[Rationale for Inclusion Criteria]"
] |
NCT03911401 | 3.4.3 | Exclusion Criteria | 3.4.3 Exclusion Criteria Subjects who fall under any of the criteria in [Table 3.4.3-1](#page-35-0) at either the screening or baseline examination will be excluded from the trial: | | Table 3.4.3-1Exclusion Criteria | |---|------------------------------------------------------------------------------------------------... | [
"[Rationale for Exclusion Criteria]"
] |
NCT03911401 | 3.5 | Endpoints | 3.5 Endpoints | [] |
NCT03911401 | 3.5.1 | Primary Endpoint | 3.5.1 Primary Endpoint Success rate in IGA at Week 4: percentage of subjects with IGA score of 0 or 1 with improvement by at least 2 grades. Subjects with missing IGA data will be handled as non-responders. [Rationale for Primary Endpoint] Investigator's Global Assessment evaluates the systemic clinical characteristics... | [] |
NCT03911401 | 3.5.2 | Secondary Endpoints | 3.5.2 Secondary Endpoints - Success rate in IGA at Week 4: percentage of subjects with IGA score of 0 or 1 - Change from baseline in IGA at Week 4 - Success rate in EASI 75 (improvement ≥75% in EASI), EASI 90 (improvement ≥90% in EASI) and EASI 50 (improvement ≥50% in EASI) at Week 4 - Change from baseline in the total... | [] |
NCT03911401 | 3.5.3 | Safety Endpoints | 3.5.3 Safety Endpoints - Adverse events - 1) AEs occurring after the start of IMP administration (Treatment-emergent adverse event [TEAE]) - 2) TEAEs by severity - 3) TEAEs resulting in death - 4) Serious TEAEs - 5) TEAEs leading to discontinuation of IMP administration - 6) TEAEs (skin and subcutaneous tissue disorder... | [] |
NCT03911401 | 3.6 | Measures to Minimize/Avoid Bias | 3.6 Measures to Minimize/Avoid Bias This trial is a randomized, double-blind trial. The IMP allocation manager will prepare a master "random allocation table" (hereinafter, "randomization table") and conduct IMP coding according to the operating procedures for randomization. Also, the IMP allocation manager will prepar... | [] |
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