protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05576012 | 8.5.1 | Investigational Drug and Matching Placebo | 8.5.1 Investigational Drug and Matching Placebo Lipum AB will provide SOL-116 and matching placebo. SOL-116 is available for clinical study use in the form of a solution for SC injection. Placebo is available as matching solution for SC administration. | [] |
NCT05576012 | 8.5.2 | Study Drug Preparation | 8.5.2 Study Drug Preparation All study drugs will be prepared (packaged and labeled in individual doses) at QPS Netherlands B.V. (for Part 1 and Part 3) or the pharmacy of the Leiden University Medical Center (LUMC) (for Part 2) by an unblinded pharmacist, or his/her designee. In order to minimize the risks of unblindi... | [] |
NCT05576012 | 8.5.3 | Study Drug Packaging | 8.5.3 Study Drug Packaging Lipum AB will be responsible for the supply of the following drugs: - Solution containing 100 mg/mL of SOL-116. - Matching placebo. The study drug will be packed and dispatched in containers. A batch release certificate will be provided, stating that the batches have been manufactured accordi... | [] |
NCT05576012 | 8.5.4 | Study Drug Labeling | 8.5.4 Study Drug Labeling The labeling complies with the applicable (local) laws and regulations. At the minimum, the following information will be stated on the labels: - Study number (LPM-116-001) - SOL-116 (strength) or placebo - Name, address of Sponsor - Name of the Investigator and CRO - Batch number - Subject/pa... | [] |
NCT05576012 | 8.5.5 | Study Drug Administration | 8.5.5 Study Drug Administration SOL-116 will be administered as abdominal SC injection(s). The injection volume will be no more than 2.0 mL per injection. The number of SC injections given to administer the single dose in Cohort 2 to Cohort 7 may be increased to up to 4 injections. Subjects/patients will not be allowed... | [] |
NCT05576012 | 8.5.6 | Storage and Return of Study Drug | 8.5.6 Storage and Return of Study Drug Upon receipt of the study drugs, the responsible pharmacist or her designee will inspect all study drugs for completeness. Subsequently, he/she must immediately return the enclosed acknowledgement of receipt form; duly completed and signed (the date of receipt must be noted). The ... | [] |
NCT05576012 | 8.6 | Safety Review Committee | 8.6 Safety Review Committee The study will be monitored by an SRC. The SRC is intended to ensure that the study drug does not pose undue risk to subjects/patients. Safety, tolerability and available PK data up to 14 days post-dose of at least 6 evaluable subjects (subject assessed as pharmacokinetically evaluable at Da... | [] |
NCT05576012 | 8.7 | Dose Escalation Strategy | 8.7 Dose Escalation Strategy | [] |
NCT05576012 | 8.7.1 | Determination of Dose Escalation/Subsequent Dosing | 8.7.1 Determination of Dose Escalation/Subsequent Dosing For Part 1: The decision to escalate to the next dose level will not take place until the SRC has reviewed the blinded safety and tolerability data, including but not limited to vital signs, ECG results, clinical laboratory tests, and AEs, up to and including 14 ... | [] |
NCT05576012 | 8.7.2 | Dose Escalation Stopping Criteria | 8.7.2 Dose Escalation Stopping Criteria - One (1) or more subjects who receive SOL-116 experience a SAE which is considered to be related to the study medication. - Two (2) or more subjects who receive SOL-116 have QTc prolongation, defined as an average absolute (regardless of baseline value) QTcF >500 msec or an incr... | [] |
NCT05576012 | 8.7.3 | Re-initiation of Dose Escalation | 8.7.3 Re-initiation of Dose Escalation If dose escalation is terminated due to the criteria noted above, reduced and/or repeat dose levels (as allowed per protocol) may be administered to provide additional data regarding the frequency and/or severity of AEs. If the SRC agrees that these additional data suggest that th... | [] |
NCT05576012 | 8.8 | Study Termination or Withdrawal of Subject/Patient from Study | 8.8 Study Termination or Withdrawal of Subject/Patient from Study | [] |
NCT05576012 | 8.8.1 | Study Termination | 8.8.1 Study Termination If the Sponsor terminates or suspends the study, the Investigator or his/her designee should promptly inform the IEC (and/or regulatory authorities where required) of a temporary halt including the reason for such an action (see also Section 12.1.10). | [] |
NCT05576012 | 8.8.2 | Subject/Patient Discontinuation or Withdrawal | 8.8.2 Subject/Patient Discontinuation or Withdrawal Subjects/patients may withdraw from the study at any time without prejudice to their future medical care by the physician or at the institution. Furthermore, a subject/patient may also be discontinued at any time should they meet the criteria defined in Section 12.1.9... | [] |
NCT05576012 | 8.8.3 | Subject's/Patient's Follow-up after Study Discontinuation or Withdrawal | 8.8.3 Subject's/Patient's Follow-up after Study Discontinuation or Withdrawal The subjects/patients will be advised that participation in these investigations is voluntary. Furthermore, the subjects/patients may request that from the time point of withdrawal no more data will be recorded and that all biological samples... | [] |
NCT05576012 | 8.8.4 | Subject/Patient Replacement | 8.8.4 Subject/Patient Replacement Drop-outs might be replaced but only upon mutual agreement between the Investigator and the Sponsor, unless withdrawal is due to a drug-related AE. The replacing subject/patient will receive the same treatment as assigned to the subject/patient whom he/she replaces. , the subjects/patients, the CRAs/monitors and the Sponsor's staff will remain blinded to the treatment until study closure. The investigational drug and its matching placebo are... | [] |
NCT05576012 | 8.10.4 | Emergency Procedure for Unblinding | 8.10.4 Emergency Procedure for Unblinding The Investigator receives emergency envelopes for each subject/patient containing the identity of the study drug dispensed. The Investigator and the study staff must remain blinded to the subject's/patient's treatment assignment, even if the subject/patient refuses to participa... | [] |
NCT05576012 | 8.11 | Study Parameters | 8.11 Study Parameters | [] |
NCT05576012 | 8.11.1 | Pharmacokinetic Parameters | 8.11.1 Pharmacokinetic Parameters The serum PK parameters for SOL-116 will be derived by non-compartmental analysis of the serum concentration-time profiles. The following PK parameters have been defined: - Area under the concentration-time curve from time zero to infinity (AUC0-inf); - Maximum observed serum concentra... | [] |
NCT05576012 | 8.11.1.1 | Calculation of Pharmacokinetic Parameters and Assumptions | 8.11.1.1 Calculation of Pharmacokinetic Parameters and Assumptions The measured individual serum concentrations of SOL-116 will be used to directly obtain Cmax and Tmax. AUC0-t will be calculated according to the linear up/log down trapezoidal method using the measured concentration-time values above the lower limit of... | [] |
NCT05576012 | 8.11.2 | Safety and Tolerability Parameters | 8.11.2 Safety and Tolerability Parameters Baseline is defined as the last value measured prior to SOL-116 administration (vital signs, ECG, laboratory parameters), unless otherwise specified. The following parameters have been defined as parameters regarding safety and tolerability: - Clinical laboratory evaluations; -... | [] |
NCT05576012 | 8.11.3 | Immunogenicity Parameters | 8.11.3 Immunogenicity Parameters The following are defined as immunogenicity parameters: - Development of ADA. If confirmed ADA positive, the following may be determined: - o Estimation of ADA titers - o Neutralizing capacity - o Isotype - o Epitope map  | [] |
NCT05576012 | 8.11.4 | Exploratory Parameters | 8.11.4 Exploratory Parameters The following are defined as exploratory parameters: - BSSL concentration; - Inflammatory biomarkers (except BSSL): CRP, ESR for all subjects/patients, and Scalprotectin and hsCRP (only RA patients); - Cytokine/chemokine panel (including but not limited to IFNγ, IL-1β, IL-6, IL-10, IL-12, ... | [] |
NCT05576012 | 9 | SAFETY DEFINITIONS AND REPORTING REQUIREMENTS | 9 SAFETY DEFINITIONS AND REPORTING REQUIREMENTS | [] |
NCT05576012 | 9.1 | Adverse Events | 9.1 Adverse Events | [] |
NCT05576012 | 9.1.1 | Definitions of Adverse Events | 9.1.1 Definitions of Adverse Events Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal labora... | [
"Adverse events include:",
"Adverse events do not include:"
] |
NCT05576012 | 9.1.2 | Intensity of Adverse Events | 9.1.2 Intensity of Adverse Events The intensity of clinical AEs is graded on a three-point scale: mild, moderate, severe, and reported on specific AE pages of the eCRF. If the intensity of an AE worsens during study drug administration, the AE will be closed and a new AE with enhanced severity will be generated in the ... | [] |
NCT05576012 | 9.1.3 | Relationship to Study Drug | 9.1.3 Relationship to Study Drug Adverse events should be assessed by the investigators as to whether or not there is a reasonable possibility of causal relationship to the study drug and reported as either related or unrelated. Related to study drug: This category applies to any AE (serious or not) that appears to hav... | [] |
NCT05576012 | 9.1.4 | Reporting of Adverse Events | 9.1.4 Reporting of Adverse Events All AEs occurring from the (first) dose administration and up to Follow-Up must be recorded on specific AE pages of the eCRF (note: only AEs for randomized subjects/patients will be recorded in the eCRF) see also Section 8.3.2.1. | [] |
NCT05576012 | 9.1.5 | Follow-up of Adverse Events | 9.1.5 Follow-up of Adverse Events Adverse events must be followed until resolution, stabilization or up to EOS. Adverse events assessed as related must be followed until resolution, stabilization or to a maximum of 28 days after the EOS. | [] |
NCT05576012 | 9.2 | Serious Adverse Events | 9.2 Serious Adverse Events | [] |
NCT05576012 | 9.2.1 | Definitions | 9.2.1 Definitions | [] |
NCT05576012 | 9.2.1.1 | Serious Adverse Events | 9.2.1.1 Serious Adverse Events A SAE is defined by the ICH guidelines as any AE fulfilling at least one of the following criteria: - Results in death. - Is life-threatening. Life-threatening refers to an event in which the subject/patient was at risk of death at the time of the event. It does not refer to an event that... | [] |
NCT05576012 | 9.2.1.2 | Pregnancy | 9.2.1.2 Pregnancy All initial reports of pregnancy, including pregnancy outcome (follow-up) in female subjects/patients or in partners of male subjects/patients, must be reported to QPS safety unit (QPS SU) by the Investigator within 24 hours of his/her knowledge of the event using a Pregnancy Form. The Investigator wi... | [] |
NCT05576012 | 9.2.1.3 | Hospitalization – Prolongation of Existing Hospitalization | 9.2.1.3 Hospitalization – Prolongation of Existing Hospitalization Hospitalization is defined as an overnight stay in a hospital unit and/or emergency room. An additional overnight stay defines a prolongation of existing hospitalization. The following is not considered an SAE and should be reported as an AE only: • Tre... | [] |
NCT05576012 | 9.2.1.4 | Serious Adverse Events Related to Study-mandated Procedures | 9.2.1.4 Serious Adverse Events Related to Study-mandated Procedures Such SAEs are defined as SAEs that appear to have a reasonable possibility of causal relationship (i.e., a relationship cannot be ruled out) to study-mandated procedures (excluding administration of study drug) such as discontinuation of subject's/pati... | [] |
NCT05576012 | 9.2.2 | Reporting of Serious Adverse Events | 9.2.2 Reporting of Serious Adverse Events | [] |
NCT05576012 | 9.2.2.1 | Before Study Drug Initiation | 9.2.2.1 Before Study Drug Initiation Serious adverse events occurring after signature of the Informed Consent and up to study drug initiation must be reported to the QPS SU. | [] |
NCT05576012 | 9.2.2.2 | During Study Drug Administration | 9.2.2.2 During Study Drug Administration All SAEs regardless of causal relationship must be reported, including those related to studymandated procedures. These SAEs occurring during study drug administration, i.e., between study drug initiation and EOS, are defined as treatment emergent SAEs. These SAEs are reported o... | [] |
NCT05576012 | 9.2.2.3 | After Study Drug Administration | 9.2.2.3 After Study Drug Administration New SAEs, including those related to study-mandated procedures, occurring after study drug administration, i.e., until EOS, must be reported.  All SAEs occurring after study drug administration until Follow-Up must be recorded on an SAE form and as AEs in... | [] |
NCT05576012 | 9.2.2.4 | Reporting Procedures | 9.2.2.4 Reporting Procedures All SAEs must be reported by a Principal Investigator to QPS SU within 24 hours of the Investigator's knowledge of the event. All SAEs must be recorded on SAE forms, irrespective of the study drug received by the subject/patient, whether or not this event is considered by the Investigator t... | [] |
NCT05576012 | 9.2.3 | Follow-up of Serious Adverse Events | 9.2.3 Follow-up of Serious Adverse Events Serious adverse events still ongoing at the EOS visit must be followed until resolution or stabilization or until the event is otherwise explained or referral to appropriate medical care. New SAEs occurring at any time after the EOS or after the 28-day follow-up period after st... | [] |
NCT05576012 | 10 | STATISTICAL METHODOLOGY AND ANALYSES | 10 STATISTICAL METHODOLOGY AND ANALYSES | [] |
NCT05576012 | 10.1 | Statistical Analysis Plan | 10.1 Statistical Analysis Plan A statistical analysis plan (SAP) will be written and finalized before the study closure, i.e., database closure and unblinding of the randomization code of the study, if applicable. The SAP will provide full details of the analyses, the data displays and the algorithms to be used for dat... | [] |
NCT05576012 | 10.2 | Analysis Sets | 10.2 Analysis Sets Five different analysis sets are defined. Subjects/patients who withdraw from the study, or who have missing data, will be included in the statistical analyses provided that they are eligible for inclusion in the analysis population as described below. All-treated set: This analysis set includes all ... | [] |
NCT05576012 | 10.2.1 | Sample Size | 10.2.1 Sample Size No formal sample size calculation has been performed. The proposed sample size is considered sufficient to provide adequate information for the study objectives. A statistical analysis plan will be prepared prior to database lock for each part of the study (see Section 10.1). | [] |
NCT05576012 | 10.2.2 | Procedure for Accounting for Missing, Unused, and Spurious Data | 10.2.2 Procedure for Accounting for Missing, Unused, and Spurious Data All analyses will be performed on data available at the time point considered. In summary tables, the number of subjects/patients with missing data will be presented unless otherwise specified. In calculation of percentages, subjects/patients with m... | [] |
NCT05576012 | 10.3 | Pharmacokinetic Parameters | 10.3 Pharmacokinetic Parameters The PK parameters will be calculated on the basis of the actual blood sampling time points. Please refer to Section 8.3.3.1 for details on the timing of sampling. | [] |
NCT05576012 | 10.3.1 | Pharmacokinetic Statistical Analysis | 10.3.1 Pharmacokinetic Statistical Analysis A definition of the PK parameters is described in Section 8.11.1. PK parameters will be described descriptively. The Per-protocol analysis set will be used for all PK analyses. Individual subject/patient listings will be provided. Mean and individual serum concentration-time ... | [] |
NCT05576012 | 10.4 | Safety and Tolerability Parameters | 10.4 Safety and Tolerability Parameters Definitions of the safety and tolerability parameters are described in Section 8.11.2. The safety set is used to perform all safety analyses. The medical history is coded using the latest version of MedDRA and listed. All AEs and SAEs are coded using the latest version of MedDRA.... | [] |
NCT05576012 | 10.5 | Immunogenicity Parameters | 10.5 Immunogenicity Parameters A definition of the immunogenicity parameters is described in Section 8.11.3.  Immunogenicity and exploratory parameters will be listed individually, displayed in appropriate graphics and summarized using descriptive statistics. | [] |
NCT05576012 | 10.6 | Exposure to Study Drug | 10.6 Exposure to Study Drug A listing with information about the study drug administration will be provided. | [] |
NCT05576012 | 10.7 | Baseline Parameters and Concomitant Medications | 10.7 Baseline Parameters and Concomitant Medications Summary statistics (mean, median, standard deviation, min, max, number of available observations) will be provided for continuous demographic variables (e.g., age, height, weight). Individual subject/patient listings of demographic data will be provided. Qualitative ... | [] |
NCT05576012 | 10.8 | Exploratory Analyses | 10.8 Exploratory Analyses A definition of the exploratory parameters is described in Section 8.11.4. Exploratory parameters will be listed individually, displayed in appropriate graphics and summarized using descriptive statistics. The PD (exploratory) set will be used. Also, the PP set and the "all-treated set" will b... | [] |
NCT05576012 | 10.9 | Interim Safety Report | 10.9 Interim Safety Report For Parts 1 and 2, the interim safety analysis will be conducted by the SRC on safety/tolerability and available PK data up to and including 14 days post-dose after completion of at least 6 evaluable subjects per treatment group (subject assessed as pharmacokinetically evaluable at Day 14). F... | [] |
NCT05576012 | 10.10 | Clinical Study Report | 10.10 Clinical Study Report Safety and tolerability parameters as well as PK and exploratory parameters (BSSL, CRP, hsCRP, ESR and S-calprotectin) will be evaluated in a Clinical Study Report. Certain exploratory parameters may be reported separately.  | [] |
NCT05576012 | 11 | REFERENCES | 11 REFERENCES - 1. Debreova M, Culenova M, Smolinska V et al. Rheumatoid arthritis: From synovium biology to cell-based therapy. Cytotherapy 2022; 24:365-75. - 2. Tanski W, S'wiatoniowska-Lonc N, Tabin N et al. The Relationship between Fatty Acids and the Development, Course and Treatment of Rheumatoid Arthritis. Nutri... | [] |
NCT05576012 | 12 | PROCEDURES AND GOOD CLINICAL PRACTICE | 12 PROCEDURES AND GOOD CLINICAL PRACTICE | [] |
NCT05576012 | 12.1 | Procedures | 12.1 Procedures | [] |
NCT05576012 | 12.1.1 | Protocol Amendments | 12.1.1 Protocol Amendments A change to a protocol has to be considered as an amendment as soon as these documents have been approved by IECs/IRBs or Health Authorities. The Sponsor is responsible to assess whether an amendment is substantial or non-substantial. Each amendment must be documented in writing by Lipum AB o... | [] |
NCT05576012 | 12.1.1.1 | Non-substantial Amendment | 12.1.1.1 Non-substantial Amendment Administrative or logistical minor changes require a non-substantial amendment. Such changes include but are not limited to changes in study staff or contact details (e.g., Lipum AB instead of CRO monitors) or minor changes in the packaging or labeling of study drug. The implementatio... | [] |
NCT05576012 | 12.1.1.2 | Substantial Amendment | 12.1.1.2 Substantial Amendment Significant changes require a substantial amendment. Significant changes include but are not limited to: new data affecting the safety of subjects/patients, change of the objectives/ parameters of the study, eligibility criteria, dose regimen, study assessments/procedures, treatment or st... | [] |
NCT05576012 | 12.1.1.3 | Urgent Amendment | 12.1.1.3 Urgent Amendment An urgent amendment might become necessary to preserve the safety of the subjects/patients included in the study. The requirements for approval should in no way prevent any immediate action being taken by the investigators or Lipum AB in the best interests of the subjects/patients. Therefore, ... | [] |
NCT05576012 | 12.1.2 | Site Monitoring | 12.1.2 Site Monitoring Clinical site monitoring is conducted by the CRA/monitor to ensure that the rights and wellbeing of human subjects are protected, that the reported study data are accurate, complete, and  verifiable, and that the conduct of the study is in compliance with the currently ap... | [] |
NCT05576012 | 12.1.3 | Data Management | 12.1.3 Data Management | [] |
NCT05576012 | 12.1.3.1 | Data Collection | 12.1.3.1 Data Collection A Subject Screening and Enrollment Log will be completed for all eligible or non-eligible subjects/patients with the reasons for exclusion. Data will be collected according to local SOP of the clinic. For each randomized subject/patient, regardless of study drug initiation, an eCRF must be comp... | [] |
NCT05576012 | 12.1.3.2 | Database Management and Quality Control | 12.1.3.2 Database Management and Quality Control After completion of the eCRF, each subject/patient will be electronically approved (signed) by the Investigator. The CRA/monitor will perform source data verification according to the MP and the SOPs of QPS Netherlands B.V. The CRA will use eCRF systems to track the moni... | [] |
NCT05576012 | 12.1.4 | Recording of Data and Retention of Documents | 12.1.4 Recording of Data and Retention of Documents The Investigator will maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be subsequently verified. These documents will be classified into two different categories: Investigator Site File (ISF), and s... | [] |
NCT05576012 | 12.1.5 | Audit | 12.1.5 Audit Lipum AB's quality assurance (QA) Manager or delegate may conduct audits of clinical research activities in accordance with internal SOPs to evaluate compliance with the principles of GCP and ICH related guidelines. Health Authorities may also wish to conduct an inspection (during the study or after its co... | [] |
NCT05576012 | 12.1.6 | Handling of Study Drug(s) | 12.1.6 Handling of Study Drug(s) Lipum AB will supply all study drug(s) to the site according to local regulations. Drug supplies must be kept in an appropriate, secure area and stored according to the conditions specified on the drug labels. The site must maintain an accurate record of the shipment and dispensing of s... | [] |
NCT05576012 | 12.1.7 | Publication of Study Results | 12.1.7 Publication of Study Results In accordance with standard editorial and ethical practice, Lipum AB will support publication of the data. | [] |
NCT05576012 | 12.1.8 | Disclosure and Confidentiality | 12.1.8 Disclosure and Confidentiality By signing the protocol, the Investigator agrees to keep all information provided by Lipum AB in strict confidence and to request similar confidentiality from his/her staff and the IEC/IRB. Study documents provided by Lipum AB (e.g. investigators' brochures, protocols, eCRFs and ot... | [] |
NCT05576012 | 12.1.9 | Stopping rules for Subject/Patient | 12.1.9 Stopping rules for Subject/Patient Should a subject/patient experience an AE or SAE that meets the following criteria, the subject/patient may be immediately discontinued from the study: - Any AE or SAE in the judgement of the Investigator or subject/patient justifies withdrawal due to its severity, nature, or r... | [] |
NCT05576012 | 12.1.10 | Premature Termination or Suspension of the Study | 12.1.10 Premature Termination or Suspension of the Study Both Lipum AB and the Investigator reserve the right to terminate the study at any time. If a study is prematurely terminated or suspended, Lipum AB will promptly inform the investigators, the IECs/IRBs and Health Authorities, as appropriate, and provide the reas... | [] |
NCT05576012 | 12.2 | Good Clinical Practice | 12.2 Good Clinical Practice | [] |
NCT05576012 | 12.2.1 | Ethics and Good Clinical Practice | 12.2.1 Ethics and Good Clinical Practice The Investigator will ensure that this study is conducted in full conformance with the principles of the "Declaration of Helsinki" (as amended in Tokyo, Venice, Hong Kong, Somerset-West, Edinburgh, Washington DC, Seoul and Fortaleza) and with the laws and regulations of the coun... | [] |
NCT05576012 | 12.2.2 | Quality Control and Quality Assurance | 12.2.2 Quality Control and Quality Assurance Quality control will be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. The Sponsor can decide to conduct an audit at the clinical study center. The audit will be conducted with the aim to ensure that the clinica... | [] |
NCT05576012 | 12.2.3 | Independent Ethics Committee / Institutional Review Board | 12.2.3 Independent Ethics Committee / Institutional Review Board The Investigator will submit this protocol and any related document provided to the subject/patient (such as subject/patient information used to obtain informed consent) to an IEC or IRB. Approval from the committee must be obtained before starting the st... | [] |
NCT05576012 | 12.2.4 | Informed Consent and Recruitment | 12.2.4 Informed Consent and Recruitment It is the responsibility of the Investigator to obtain written informed consent from each individual participating in this study after adequate explanation of the aims, methods, and objectives of the study and potential hazards of the study drug. The Investigator must also explai... | [] |
NCT05576012 | 12.2.5 | Compensation to Subjects/Patients and Investigators | 12.2.5 Compensation to Subjects/Patients and Investigators Lipum AB is providing insurance in order to indemnify (legal and financial coverage) the Investigator/center against claims arising from the study, except for claims that arise from malpractice and/or negligence. The compensation of the subject/patient in the e... | [] |
NCT05576012 | 13 | STRUCTURED RISK ANALYSIS | 13 STRUCTURED RISK ANALYSIS | 13.1Potential Issues of Concern | | |------------------------------------------------------------------------------------------------------------------|--| | 13.1.1Level of Knowledge About Mechanism of Action | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 13.1.2Previous ... | [] |
NCT05576012 | 13.1.7 | Study Population | 13.1.7 Study Population Up to 48 healthy male and female volunteers, and 1 cohort of 8 RA patients will be enrolled, aged between 18-65 years. Females of childbearing potential may be enrolled if they agree to use appropriate contraception. | [] |
NCT05576012 | 13.1.8 | Interaction with Other Products | 13.1.8 Interaction with Other Products Metabolism and potential metabolic interactions have not been investigated. Based on the fact that both SOL-116 and its target BSSL being proteins, and since SOL-116 is not directly binding proinflammatory cytokines, there are no expected drug-drug interactions with small molecule... | [] |
NCT05576012 | 13.1.9 | Predictability of Effect | 13.1.9 Predictability of Effect The PK behavior of SOL-116 in the preclinical studies appears predictable and in line with what is expected after s.c. injections of a monoclonal antibody.  | [] |
NCT05576012 | 13.1.10 | Can Effects be Managed? | 13.1.10 Can Effects be Managed? No antidote is available. Treatment of adverse effect will be symptomatic, tailored to the nature of the events. Subjects with a history or known hypersensitivity or allergy are excluded from participation in the study. There is also immediate access to equipment, qualified staff and an ... | [] |
NCT05576012 | 13.2 | Synthesis | 13.2 Synthesis This is a First-in-Human trial with a First-in-Class novel investigational medicinal product. Given the available nonclinical safety data, the selected starting dose and the oversight of dose escalation steps by a Safety Review Committee and ethics committee, the overall risk assessments are acceptable i... | [] |
NCT05576012 | 13.3 | Category study | 13.3 Category study | Conclusions | Based on the risk analysis the study can beperformed without additional conditions. | |-------------|----------------------------------------------------------------------------------------------------| | | Based on the risk analysis the study can beperformed with the following addit... | [] |
NCT00555971 | 1 | INTRODUCTION | 1 INTRODUCTION Omalizumab was recently approved by the FDA for management of patients with moderatesevere asthma, who are not achieving the goals of asthma management despite pursuing appropriate avoidance measures and taking regular "controller" medications. Based on evidence demonstrating its utility for improving as... | [
"BACKGROUND",
"Aspirin dosages"
] |
NCT00555971 | 2 | STUDY OBJECTIVES | 2 STUDY OBJECTIVES
PRIMARY AIM: To assess the impact of Omalizumab on aspirin-induced bronchospasm occurring during aspirin desensitization in patients with AERD.
PRIMARY OUTCOME OF INTEREST: Aspirin-induced respiratory reaction as defined by the decline in the forced expiratory volume in one second (FEV1) values fro... | [
"PRIMARY AIM:",
"PRIMARY OUTCOME OF INTEREST:",
"SECONDARY OUTCOMES OF INTEREST:"
] |
NCT00555971 | 3 | INVESTIGATIONAL PLAN | 3 INVESTIGATIONAL PLAN | [] |
NCT00555971 | 3.1 | OVERALL STUDY DESIGN | 3.1 OVERALL STUDY DESIGN
Design: The study will be a randomized double-blind placebo-controlled evaluation of the impact of Omalizumab on aspirin desensitization in patients with AERD. Patients who are candidates for aspirin desensitization will be offered the opportunity to participate in this study, and will receive... | [
"Design:"
] |
NCT00555971 | 3.2 | STUDY POPULATION | 3.2 STUDY POPULATION We intend to offer participation to all patients with AERD seen at the Cleveland Clinic Foundation - Patients will fulfill the following criteria, according to Xolair label: - o AERD confirmed by history and clinical course - o Atopic as determined by immediate hypersensitivity skin testing or RAST... | [
"Inclusion criteria",
"Exclusion criteria"
] |
NCT00555971 | 3.3 | TREATMENTS | 3.3 TREATMENTS
INVESTIGATIONAL THERAPY AND REFERENCE THERAPY Patients with AERD who are candidates for aspirin desensitization will be offered the opportunity to participate. Once enrolled, patients will receive either Omalizumab (administered according to Xolair label) or identical placebo. Subjects will receive 4 in... | [
"INVESTIGATIONAL THERAPY AND REFERENCE THERAPY",
"TREATMENT, ASSIGNMENT, BLINDING AND RANDOMIZATION",
"CONCOMITANT THERAPY",
"INTERRUPTION OR DISCONTINUATION OF TREATMENT",
"TREATMENT COMPLIANCE"
] |
NCT00555971 | 3.4 | VISITS AND ASSESSMENTS | 3.4 VISITS AND ASSESSMENTS
Study Timetable Duration of participation = approximately 24 weeks (6 months) - Phase A: Entry - Phase B: Xolair/Placebo (approximately 16 weeks) - Phase C: Aspirin Desensitization (1-3 weeks after Phase B) - Phase D: Aspirin Desensitization Treatment (approximately 1 month after Phase C) | ... | [
"Study Timetable",
"\\ Informed consent may take place prior to Phase A, while the patient is completing an outpatient visit.",
"Phase A - Enrollment",
"Phase B – Xolair/Placebo",
"Baseline:",
"Week 4, 8, and 12 (receiving injections every 4 weeks +/- 7 days):",
"Week 2, 4, 6, 8, 10, 12, 14 (receiving i... |
NCT00555971 | 3.5 | SAFETY ASSESSMENTS | 3.5 SAFETY ASSESSMENTS Safety assessments will consist of monitoring and recording all adverse events, including serious adverse events, as described in the study manual. An adverse event is any undesirable sign, symptom or medical condition occurring after starting study drug (or therapy). Medical conditions/diseases ... | [] |
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