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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004162-18 | EudraCT Number | ||
| U1111-1253-2343 | Other Identifier | UTN |
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Primary Objective:
- To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP)
Secondary Objectives:
Study duration:
Visit frequency:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR445088 | Experimental | Participants received SAR445088 (BIVV020). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR445088 (BIVV020) | Drug | Pharmaceutical form:solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Durable Platelet Response | A naive participant was a participant who did not use sutimlimab prior to enrollment. A switcher was a participant who used sutimlimab prior to enrollment. A naive participant was a responder if the platelet count was >=50 × 10^9/liter (L) at >=50 percent (%) of scheduled visits, or for participants with baseline platelet count <15 × 10^9/L, a >=20 × 10^9/L increase in platelet count from baseline at >=50% of scheduled visits, without receiving rescue immune thrombocytopenia (ITP) therapy. A switcher was a responder if the maintenance platelet count was >=30 × 10^9/L at >=50% of scheduled visits, without receiving rescue ITP therapy. | From Week 3 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (SAE) | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed after the first study treatment administration in the safety analysis period which was defined as the period from the first study intervention administration to the end of study (EOS) visit (up to Week 103). |
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Inclusion criteria :
Male and female participants ≥18 years of age at the time of signing the informed consent
Confirmed diagnosis of primary ITP; for participants who previously received sutimlimab in study TDR16218 (NCT03275454), a response to sutimlimab must have been obtained, as defined by platelet count ≥30 × 10^9/L on 2 visits at least 7 days apart
For participants who have not previously received sutimlimab: persistent/chronic ITP (ITP lasting for ≥6 months) and all the following conditions:
Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitidis, including serogroup B where available, Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years of enrollment
Contraceptive use for women of childbearing potential and men who were sexually active with a female partner of childbearing potential
Exclusion criteria:
Participants were excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :8400001 | Washington D.C. | District of Columbia | 20007 | United States | ||
| Investigational Site Number :8400002 |
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| Label | URL |
|---|---|
| PDY16894 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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The study consisted of a screening period (up to 56 days), treatment period (up to 81 weeks), and follow-up visits (up to 22 weeks). A total of 12 participants [either switchers: who had received and responded to sutimlimab (BIVV009) in study TDR16218 (NCT03275454) or naïve: who have not previously received sutimlimab] were enrolled in this study.
The study was conducted at 8 centers in 5 countries. A total of 20 participants were screened from 04 Feb 2021 to 07 Sep 2021, of which 8 were screen failures due to not meeting eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | SAR445088 | Participants received a loading dose of SAR445088 (BIVV020) 50 milligram per kilogram (mg/kg) intravenously (IV) on Day 1, followed by maintenance doses of 600 mg subcutaneous (SC) weekly starting on Day 8 until the last participant enrolled completed 52 weeks of treatment. The maximum duration of treatment for an individual participant was up to 81 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2021 | Dec 1, 2023 |
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| From first study treatment administration (Day 1) up to Week 103 |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematology | Criteria for potentially clinically significant laboratory abnormalities (PCSA): White blood cells: less than (<)3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]), greater than or equal to (>=)16.0 Giga/L; Lymphocytes: greater than (>)4.0 Giga/L; Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); Monocytes: >0.7 Giga/L; Basophils: >0.1 Giga/L; Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L); Hemoglobin: less than or equal to (<=) 115 grams per liter (g/L) (Male[M]) or <=95 g/L (Female[F]), >=185 g/L (M) or >=165 g/L (F), Decrease from baseline (DFB) >=20 g/L; Hematocrit: <=0.37 volume/volume (v/v) (M) or <=0.32 v/v (F); Red blood cells (RBC): >=6 Tera/L; Platelets:<100 Giga/L, >=700 Giga/L. Only the worst case during the treatment-emergent (TE) period for each participant with worsening from baseline is presented. | On Days 1, 15, 29, at Weeks 8, 12, 24, and then every 8 weeks until the end of study (EOS) (Week 103) |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Clinical Chemistry | Criteria for PCSA: Blood Urea Nitrogen: >=17 millimole (mmol)/L; Creatinine: >=150 micromole (mcmol)/L (Adults), >=30% and <100% change from baseline, >=100% change from baseline; Potassium: <3 mmol/L, >=5.5 mmol/L; Sodium: <=129 mmol/L, >=160 mmol/L; Aspartate Aminotransferase (AST): >3 ULN, >5 ULN, >10 ULN, >20 ULN; Alanine Aminotransferase (ALT): >3 ULN, >5 ULN, >10 ULN, >20 ULN; Alkaline Phosphatase (ALP): >1.5 ULN; Bilirubin: >1.5 ULN, >2 ULN; ALT and Total Bilirubin: ALT >3 ULN and TBILI >2 ULN. Only the worst case during the TE period for each participant with worsening from baseline is presented. | On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103) |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Coagulation | The number of participants with PCSA for coagulation parameters during the TE period without PCSA definition by biological function are presented. The parameters evaluated were prothrombin time, prothrombin international normalized ratio and activated partial thromboplastin time (APTT). | On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103) |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Urinalysis | Criteria for PCSA: potential of Hydrogen (pH) <=4.6, >=8. Only the worst case during the TE period for each participant with worsening from baseline is presented. | On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103) |
| Plasma Concentrations of SAR445088 (BIVV020) | Plasma samples were collected at specified timepoints. | 1-hour post-dose on Day 1, on Days 8, 15, 29, 43, at Weeks 12, 16, 24, 32, 40, 48, 56, 64, 72, 80 and EOS visit, up to 103 weeks |
| Number of Responders to SAR445088 (BIVV020) | A participant was a responder if the platelet count was >=50 × 10^9/L and there was a greater than 2-fold increase from baseline, measured on 2 occasions at least 7 days apart with the absence of bleeding [bleeding score >=2 on the World Health Organization (WHO) bleeding scale] while the platelet counts were maintained above the threshold and lack of combination ITP therapy during this period. WHO bleeding scores: 1=Petechiae; 2=Mild blood loss; 3=Gross blood loss; and 4=Debilitating blood loss. | At Weeks 24 and 56 |
| Time to First Platelet Response | Time to first platelet response was defined as greater than or equal to each of the following values: 50 × 10^9/L or 100 × 10^9/L (confirmed by 2 measurements at least 7 days apart). It was calculated as date of first occurrence of confirmed platelet count response before rescue therapy. | From Baseline (Day 1) up to Week 56 |
| Percentage of Participants Who Did Not Require Rescue Therapy for an Acute Episode of Thrombocytopenia After Week 3 | Data was collected to assess the effect of treatment with SAR445088 (BIVV020) on the requirement for rescue ITP therapy. | Up to Week 84 |
| Number of Participants With Anti-Drug Antibody (ADAs) Response to SAR445088 (BIVV020) | Plasma samples were analyzed for the presence of ADAs for SAR445088 (BIVV020) using validated assays. Treatment-induced ADA was defined as ADAs that developed during the treatment-emergent period and without pre-existing ADA. Pre-existing ADA was defined as ADAs present in samples drawn before first study treatment administration. Treatment-boosted ADA positive was defined as pre-existing ADA (i.e., ADA positive at baseline) that was boosted at least a 9-fold increase of titer values during the treatment-emergent period than the baseline. Treatment-emergent ADA positive was defined as either treatment-induced ADA positive or treatment-boosted ADA positive during the treatment-emergent period. Inconclusive ADA was defined as the one that could not irrefutably be classified as with or without treatment-emergent ADA. | Up to Week 103 |
| Tamarac |
| Florida |
| 33321 |
| United States |
| Investigational Site Number :2030002 | Ostrava - Poruba | 70852 | Czechia |
| Investigational Site Number :2760001 | Essen | 45147 | Germany |
| Investigational Site Number :5280001 | Leiden | 2333 ZA | Netherlands |
| Investigational Site Number :7240002 | A Coruña | A Coruña [La Coruña] | 15006 | Spain |
| Investigational Site Number :7240001 | Palma de Mallorca | 07120 | Spain |
| Investigational Site Number :7240003 | Seville | 41013 | Spain |
| Investigational Site Number :8260002 | London | London, City of | W12 0HS | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Enrolled population consisted of all participants from screened population who had been allocated to a treatment regardless of whether the treatment was received or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | SAR445088 | Participants received a loading dose of SAR445088 (BIVV020) at 50 mg/kg IV on Day 1, followed by maintenance doses of 600 mg SC weekly starting on Day 8 until the last participant enrolled completed 52 weeks of treatment. The maximum duration of treatment for an individual participant was up to 81 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Durable Platelet Response | A naive participant was a participant who did not use sutimlimab prior to enrollment. A switcher was a participant who used sutimlimab prior to enrollment. A naive participant was a responder if the platelet count was >=50 × 10^9/liter (L) at >=50 percent (%) of scheduled visits, or for participants with baseline platelet count <15 × 10^9/L, a >=20 × 10^9/L increase in platelet count from baseline at >=50% of scheduled visits, without receiving rescue immune thrombocytopenia (ITP) therapy. A switcher was a responder if the maintenance platelet count was >=30 × 10^9/L at >=50% of scheduled visits, without receiving rescue ITP therapy. | Results are based on the overall number of participants analyzed = intent-to-treat (ITT) population which consisted of all exposed participants. Number analyzed = number of participants for each category (naive participant and switcher). | Posted | Number | 95% Confidence Interval | percentage of participants | From Week 3 to Week 24 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (SAE) | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were AEs that developed after the first study treatment administration in the safety analysis period which was defined as the period from the first study intervention administration to the end of study (EOS) visit (up to Week 103). | The Safety population consisted of all enrolled participants who took at least 1 dose (including partial dose) of study treatment. | Posted | Count of Participants | Participants | No | From first study treatment administration (Day 1) up to Week 103 |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematology | Criteria for potentially clinically significant laboratory abnormalities (PCSA): White blood cells: less than (<)3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]), greater than or equal to (>=)16.0 Giga/L; Lymphocytes: greater than (>)4.0 Giga/L; Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); Monocytes: >0.7 Giga/L; Basophils: >0.1 Giga/L; Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L); Hemoglobin: less than or equal to (<=) 115 grams per liter (g/L) (Male[M]) or <=95 g/L (Female[F]), >=185 g/L (M) or >=165 g/L (F), Decrease from baseline (DFB) >=20 g/L; Hematocrit: <=0.37 volume/volume (v/v) (M) or <=0.32 v/v (F); Red blood cells (RBC): >=6 Tera/L; Platelets:<100 Giga/L, >=700 Giga/L. Only the worst case during the treatment-emergent (TE) period for each participant with worsening from baseline is presented. | Overall number of participants analyzed = safety population. Number analyzed = number of participants in the 'safety population' with available data for the corresponding categories. The Safety population consisted of all enrolled participants who took at least 1 dose (including partial dose) of study treatment. Only those participants with data available were analyzed. | Posted | Count of Participants | Participants | No | On Days 1, 15, 29, at Weeks 8, 12, 24, and then every 8 weeks until the end of study (EOS) (Week 103) |
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Clinical Chemistry | Criteria for PCSA: Blood Urea Nitrogen: >=17 millimole (mmol)/L; Creatinine: >=150 micromole (mcmol)/L (Adults), >=30% and <100% change from baseline, >=100% change from baseline; Potassium: <3 mmol/L, >=5.5 mmol/L; Sodium: <=129 mmol/L, >=160 mmol/L; Aspartate Aminotransferase (AST): >3 ULN, >5 ULN, >10 ULN, >20 ULN; Alanine Aminotransferase (ALT): >3 ULN, >5 ULN, >10 ULN, >20 ULN; Alkaline Phosphatase (ALP): >1.5 ULN; Bilirubin: >1.5 ULN, >2 ULN; ALT and Total Bilirubin: ALT >3 ULN and TBILI >2 ULN. Only the worst case during the TE period for each participant with worsening from baseline is presented. | The Safety population consisted of all enrolled participants who took at least 1 dose (including partial dose) of study treatment. | Posted | Count of Participants | Participants | No | On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103) |
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| Secondary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Coagulation | The number of participants with PCSA for coagulation parameters during the TE period without PCSA definition by biological function are presented. The parameters evaluated were prothrombin time, prothrombin international normalized ratio and activated partial thromboplastin time (APTT). | Overall number of participants analyzed = Number of participants in the 'safety population' with available data for this outcome measure. Number analyzed = number of participants in the 'safety population' with available data for the corresponding categories. Some participants in 'Number Analyzed' were common for 2 or for all the 3 categories (Prothrombin time, Prothrombin International Normalized Ratio and APTT). | Posted | Count of Participants | Participants | No | On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103) |
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| Secondary | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Urinalysis | Criteria for PCSA: potential of Hydrogen (pH) <=4.6, >=8. Only the worst case during the TE period for each participant with worsening from baseline is presented. | The Safety population consisted of all enrolled participants who took at least 1 dose (including partial dose) of study treatment. | Posted | Count of Participants | Participants | No | On Days 1, 15, 29, Weeks 8, 12 and 24, then every 8 weeks until the EOS (Week 103) |
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| Secondary | Plasma Concentrations of SAR445088 (BIVV020) | Plasma samples were collected at specified timepoints. | The Pharmacokinetic (PK) population consisted of all enrolled and treated participants (safety population) with at least 1 post-baseline PK sample. Only those participants with data available were included in the analysis. | Posted | Mean | Standard Deviation | microgram/milliliter (mcg/mL) | 1-hour post-dose on Day 1, on Days 8, 15, 29, 43, at Weeks 12, 16, 24, 32, 40, 48, 56, 64, 72, 80 and EOS visit, up to 103 weeks |
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| Secondary | Number of Responders to SAR445088 (BIVV020) | A participant was a responder if the platelet count was >=50 × 10^9/L and there was a greater than 2-fold increase from baseline, measured on 2 occasions at least 7 days apart with the absence of bleeding [bleeding score >=2 on the World Health Organization (WHO) bleeding scale] while the platelet counts were maintained above the threshold and lack of combination ITP therapy during this period. WHO bleeding scores: 1=Petechiae; 2=Mild blood loss; 3=Gross blood loss; and 4=Debilitating blood loss. | The ITT population consisted of all exposed participants. | Posted | Count of Participants | Participants | No | At Weeks 24 and 56 |
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| Secondary | Time to First Platelet Response | Time to first platelet response was defined as greater than or equal to each of the following values: 50 × 10^9/L or 100 × 10^9/L (confirmed by 2 measurements at least 7 days apart). It was calculated as date of first occurrence of confirmed platelet count response before rescue therapy. | Overall number of participants analyzed = ITT Population which consisted of all exposed participants. Number analyzed = number of participants in the 'ITT Population' who met the specified platelet counts (>=50 x10^9/L or >=100 x10^9/L) as confirmed by 2 measurements at least 7 days apart. Participants who met the criteria 'Platelet count >=100 x10^9/L' were the same as who met the criteria 'Platelet count >=50 x10^9/L'. | Posted | Median | Inter-Quartile Range | weeks | From Baseline (Day 1) up to Week 56 |
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| Secondary | Percentage of Participants Who Did Not Require Rescue Therapy for an Acute Episode of Thrombocytopenia After Week 3 | Data was collected to assess the effect of treatment with SAR445088 (BIVV020) on the requirement for rescue ITP therapy. | The ITT population consisted of all exposed participants. | Posted | Number | percentage of participants | Up to Week 84 |
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| Secondary | Number of Participants With Anti-Drug Antibody (ADAs) Response to SAR445088 (BIVV020) | Plasma samples were analyzed for the presence of ADAs for SAR445088 (BIVV020) using validated assays. Treatment-induced ADA was defined as ADAs that developed during the treatment-emergent period and without pre-existing ADA. Pre-existing ADA was defined as ADAs present in samples drawn before first study treatment administration. Treatment-boosted ADA positive was defined as pre-existing ADA (i.e., ADA positive at baseline) that was boosted at least a 9-fold increase of titer values during the treatment-emergent period than the baseline. Treatment-emergent ADA positive was defined as either treatment-induced ADA positive or treatment-boosted ADA positive during the treatment-emergent period. Inconclusive ADA was defined as the one that could not irrefutably be classified as with or without treatment-emergent ADA. | The ADA population consisted of all enrolled and treated participants (safety population) with at least 1 post-baseline ADA sample. | Posted | Count of Participants | Participants | No | Up to Week 103 |
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The TEAEs were collected from first study treatment administration (Day 1) up to Week 103
The Safety population consisted of all enrolled participants who took at least 1 dose (including partial dose) of study treatment. As prespecified, AEs recorded for doses 50 mg/kg (loading dose) and 600 mg (maintenance dose) of SAR445088 are presented under the reporting group, SAR445088.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAR445088 | Participants received a loading dose of SAR445088 (BIVV020) at 50 mg/kg IV on Day 1, followed by maintenance doses of 600 mg SC weekly starting on Day 8 until the last participant enrolled completed 52 weeks of treatment. The maximum duration of treatment for an individual participant was up to 81 weeks. | 0 | 12 | 2 | 12 | 8 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Post-Acute Covid-19 Syndrome | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDra 25.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 25.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
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| Burning Sensation | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra 25.1 | Systematic Assessment |
| |
| Eye Irritation | Eye disorders | MedDra 25.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDra 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 25.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDra 25.1 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDra 25.1 | Systematic Assessment |
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| Cholecystitis Chronic | Hepatobiliary disorders | MedDra 25.1 | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDra 25.1 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDra 25.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 25.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDra 25.1 | Systematic Assessment |
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| Injection Site Bruising | General disorders | MedDra 25.1 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDra 25.1 | Systematic Assessment |
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| Blood Cholesterol Increased | Investigations | MedDra 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 8006331610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2021 | Dec 1, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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