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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003539-12 | EudraCT Number | ||
| BIVV009-04 | Other Identifier | Bioverativ Therapeutics Inc. |
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The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.
The planned total study duration per participant was approximately 1.5 to 2.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIVV009/BIVV009 | Experimental | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an intravenous (IV) infusion of BIVV009 6.5 g (for participants less than [<]75 kilograms [kg]) or 7.5 g dose (for participants greater than or equal to [>=]75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
| Placebo/BIVV009 | Experimental | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sutimlimab (BIVV009) | Drug | Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Percentage of Participants With Response to Treatment | A participant was considered a responder: if he or she did not receive blood transfusion from Week 5 through Week 26 (end of treatment) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, participant's hemoglobin (Hgb) level must have increased to >=1.5 grams per deciliter (g/dL) from baseline (defined as last Hgb value before administration of first dose of study drug) at treatment assessment timepoint (defined as average of values from the Week 23, 25, and 26 visits). Percentage of responders was calculated together with 95% exact Clopper-Pearson confidence interval (CI). | From Week 5 through Week 26 |
| Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Adverse Event (AE): any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Treatment emergent serious adverse events (TESAEs) was defined as 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 congenital anomaly/birth defect, was medically important event. Treatment emergent adverse events (TEAEs): AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from first investigational medicinal product [IMP] administration in Part B to last IMP administration + 9 weeks follow-up period). | Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Mean change from baseline (Week 0) in Hemoglobin (Hgb) at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Least squares (LS) mean and 95 % confidence interval (CI) was assessed by Mixed Model for Repeated Measures (MMRM) approach using heterogeneous Toeplitz (TOEPH) covariance matrix with change from baseline as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug. |
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Inclusion criteria:
Exclusion criteria:
The above information was 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 |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates PC | Tucson | Arizona | 85711 | United States | ||
| USC/Keck School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36403132 | Derived | Roth A, Broome CM, Barcellini W, Jilma B, Hill QA, Cella D, Tvedt THA, Yamaguchi M, Lee M, Shafer F, Wardecki M, Jiang X, Patel P, Joly F, Weitz IC. Sutimlimab provides clinically meaningful improvements in patient-reported outcomes in patients with cold agglutinin disease: Results from the randomised, placebo-controlled, Phase 3 CADENZA study. Eur J Haematol. 2023 Mar;110(3):280-288. doi: 10.1111/ejh.13903. Epub 2022 Dec 9. | |
| 35687757 |
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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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Participants were stratified based on baseline body weight to receive BIVV009 6.5 grams (g) (if <75 kg) or 7.5 g (if >=75 kg). As planned, data presented as: 1) Dose-wise (2 dose cohorts: BIVV009 6.5 g & BIVV009 7.5 g) for safety outcome measures and adverse events (AEs). 2) combined population (BIVV009 at any dose) for efficacy outcome measures.
The study was conducted at 27 sites in 13 countries. Out of 66 screened participants, a total of 42 participants were enrolled and randomized from 17 March 2018 to 30 March 2020. This study consisted of 2 Parts: Part A and Part B.
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| ID | Title | Description |
|---|---|---|
| FG000 | BIVV009/BIVV009 | Participants with primary Cold Agglutinin Disease (CAD) and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an intravenous (IV) infusion of BIVV009 6.5 g (for participants less than [<]75 kilograms [kg]) or 7.5 g dose (for participants greater than or equal to [>=]75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A (26 Weeks) |
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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 | Nov 4, 2020 | Dec 1, 2022 |
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| placebo | Drug | Pharmaceutical form: solution for injection Route of administration: intravenous (i.v.) |
|
| Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) |
| Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. Total score ranged from 0 to 52, with higher score indicating more fatigue. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. LS mean and 95% CI was assessed by MMRM approach using TOEPH covariance matrix with change from baseline (Week 0) as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug. | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) |
| Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint | Mean change from baseline (Week 0) in total bilirubin at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug. | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) |
| Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Mean change from baseline (Week 0) in LDH at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug. | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) |
| Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Symptomatic anemia was defined as having following symptoms: i. Fatigue; ii. Weakness; iii. Shortness of breath; iv. Palpitations, fast heartbeat; v. Light headedness and/or vi. Chest pain. Percentage of participants with solicited symptomatic anemia symptoms was reported in this outcome measure. | Week 26 |
| Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Change from baseline (Week 0) in Hgb levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43,45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83,85,87, 89,91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147,149,151,153, 155,157,159,161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. Early Termination (ET) visit/safety follow up (SFU) visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) |
| Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Change from baseline (Week 0) in total bilirubin levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65,67,69,71,73,75, 77, 79, 81,83, 85, 87, 89, 91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121, 123, 125, 127,129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) |
| Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. The Total score ranged from 0 to 52, with higher score indicating more fatigue. Baseline (Week 0) was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
| Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | SF-12: 12 item-questionnaire assessed health-related quality of life (HRQOL), contained 12 items, categorized into 8 domains (subscales) of functioning and well-being: physical functioning, role-physical, role emotional, mental health, bodily pain, general health, vitality and social functioning, with each domain score ranged from 0 (poor health) to 100 (better health). Higher scores = good health condition. These 8 domains were further summarized into 2 summary scores, PCS and MCS that ranged from 0 (poor health) to 100 (better health). Higher scores = better HRQOL. Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184). | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
| Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | EQ-5D-5L included 2 components: health state utility index (descriptive system) and Visual Analog Scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response option: no problem, slight problem, moderate problem, severe problem and extreme problems measured with Likert scale. EQ-5D-5L responses converted into single index utility score between 0 to 1. Higher score=better health. EQ-5D-5L VAS rated participant's current health state on scale from 0 (worst imaginable health) to 100 (best imaginable health). Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184). | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
| Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | The PGIS is a self-reported scale. The PGIS is a 1-item questionnaire designed to assess participant's impression of disease severity using a 5-point scale ranging from 1 to 5, where 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
| Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | PGIC is a self-administered questionnaire to evaluate the improvement or worsening compared to the start of the study. PGIC was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGIC scores as follows: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worsen. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
| Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Change from baseline (Week 0) in LDH levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 105, 107,109, 111, 113, 115, 117, 119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147, 149, 151,153,155,157,159,161,163,165,167,169, 171, 173, 175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) |
| Part B: Number of Blood Transfusions Per Participant | A participant was to receive a transfusion if his or her Hgb level met either of the following criteria: Hgb was <9 g/dL and the participant had symptoms of anemia or Hgb was <7 g/dL and the participant was asymptomatic. | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) |
| Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Change from baseline (Week 0) in haptoglobin values at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97,99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127, 129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Haptoglobin values <0.2 were imputed as 0.2. | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) |
| Part B: Number of Healthcare Visits by Type | In this outcome measure, number of healthcare visits which included non-study healthcare resource utilization visit (consisted mainly of extra visits to the office of the study doctor, visit to a generalist doctor or visit to a specialist doctor), hospitalization visit and visit to hospital emergency is reported. | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) |
| Los Angeles |
| California |
| 90033 |
| United States |
| Georgetown University Medical Center | Georgetown | District of Columbia | 20007 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Montefiore Medical Center | New York | New York | 10461 | United States |
| New York Medical College at Westchester Medical Center | Valhalla | New York | 10595 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| UW Hospitals and Clinics | Madison | Wisconsin | 53792 | United States |
| USC Health Clinics | Buderim | Queensland | 4556 | Australia |
| Ballarat Oncology & Haematology | Ballarat | Victoria | 3350 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Perth Blood Institute | West Perth | Western Australia | 6005 | Australia |
| Medical University of Vienna | Vienna | 1090 | Austria |
| ZNA Stuivenberg | Antwerp | 2060 | Belgium |
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| McGill University Health Center | Montreal | Quebec | H4A3J1 | Canada |
| CHU d'Angers | Angers | 49933 | France |
| Hôpital de Caen | Caen | 14033 | France |
| Centre Hospitalier Henri Mondor | Créteil | 94000 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Gemeinschaftspraxis Hämatologie-Onkologie | Dresden | 1307 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Univ Ulm, Inst Klin. Transfusions. Immungen | Ulm | 89081 | Germany |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Laniado Hospital | Netanya | 4244916 | Israel |
| A. O. Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| U.O.C. Ematologia- Policlinico "A. Gemelli" | Rome | 00168 | Italy |
| U.O.C. Ematologia Ospedale San Bortolo | Vicenza | 36100 | Italy |
| Japanese Red Cross Society Himeji Hospital | Himeji | Hyōgo | 670-8540 | Japan |
| Ishikawa Prefectural Central Hospital | Kanazawa | Ishikawa-ken | 9208530 | Japan |
| Tokai University Hospital | Isehara | Kanagawa | 259-1193 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| Saitama Medical University Hospital | Iruma-gun | Saitama | 350-0495 | Japan |
| Aichi Medical University Hospital | Nagakute | 480-1195 | Japan |
| Academisch Medisch Centrum | Amsterdam | 1105 | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | 2333 | Netherlands |
| Haukeland University Hospital | Bergen | 5053 | Norway |
| St Olavs Hospital, Avdeling for blodsykdommer | Trondheim | 7030 | Norway |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Clinci i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| St James Hospital, Leeds | Leeds | LS9 7TF | United Kingdom |
| Imperial College Healthcare NHS Trust, Hammersmith Hospital | London | W12 0HS | United Kingdom |
| University College London | London | WC1E 6AG | United Kingdom |
| Derived |
| Roth A, Berentsen S, Barcellini W, D'Sa S, Jilma B, Michel M, Weitz IC, Yamaguchi M, Nishimura JI, Vos JMI, Storek M, Wong N, Patel P, Jiang X, Vagge DS, Wardecki M, Shafer F, Lee M, Broome CM. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022 Sep 1;140(9):980-991. doi: 10.1182/blood.2021014955. |
| FG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
| COMPLETED |
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| NOT COMPLETED |
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| Part B (149 Weeks) |
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Analysis was performed on full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | BIVV009/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g (for participants <75 kg) or 7.5 g dose (for participants >=75 kg) on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26), received placebo on Week 26 and continued to receive BIVV009 6.5 or 7.5 g in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks (for 6.5 g) or 121 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
| BG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Part A: Percentage of Participants With Response to Treatment | A participant was considered a responder: if he or she did not receive blood transfusion from Week 5 through Week 26 (end of treatment) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, participant's hemoglobin (Hgb) level must have increased to >=1.5 grams per deciliter (g/dL) from baseline (defined as last Hgb value before administration of first dose of study drug) at treatment assessment timepoint (defined as average of values from the Week 23, 25, and 26 visits). Percentage of responders was calculated together with 95% exact Clopper-Pearson confidence interval (CI). | Analysis was performed on Part A-full analysis set (FAS) which included all randomized participants who received at least 1 dose (including partial dose) of study drug (BIVV009 or placebo). Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A. | Posted | Number | 95% Confidence Interval | percentage of participants | From Week 5 through Week 26 |
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| Primary | Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Adverse Event (AE): any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Treatment emergent serious adverse events (TESAEs) was defined as 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 congenital anomaly/birth defect, was medically important event. Treatment emergent adverse events (TEAEs): AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from first investigational medicinal product [IMP] administration in Part B to last IMP administration + 9 weeks follow-up period). | Analyzed on Part B safety analysis set (SAS) which included all participants who received at least 1 dose (including partial dose) of study drug in Part B. Data for this outcome measures was planned to be collected and analyzed separately for each dose of BIVV009 (6.5 g and 7.5 g). | Posted | Count of Participants | Participants | Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172) |
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| Secondary | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Mean change from baseline (Week 0) in Hemoglobin (Hgb) at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Least squares (LS) mean and 95 % confidence interval (CI) was assessed by Mixed Model for Repeated Measures (MMRM) approach using heterogeneous Toeplitz (TOEPH) covariance matrix with change from baseline as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug. | Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A. | Posted | Least Squares Mean | 95% Confidence Interval | grams per deciliter | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) |
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| Secondary | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. Total score ranged from 0 to 52, with higher score indicating more fatigue. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. LS mean and 95% CI was assessed by MMRM approach using TOEPH covariance matrix with change from baseline (Week 0) as the dependent variable and baseline value and visits as independent variables. Baseline was defined as the last non-missing value prior to the first administration of study drug. | Analysis was performed on Part A-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) |
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| Secondary | Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint | Mean change from baseline (Week 0) in total bilirubin at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug. | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either at 6.5 or 7.5 g] and placebo in Part A. | Posted | Mean | Standard Deviation | micromoles per liter | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) |
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| Secondary | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Mean change from baseline (Week 0) in LDH at the treatment assessment timepoint is reported in this outcome measure. Treatment assessment timepoint was defined as the average of the values from the Week 23, 25, and 26 visits. Baseline was defined as the last non-missing value prior to the first administration of study drug. | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A. | Posted | Mean | Standard Deviation | units per liter | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) |
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| Secondary | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | Symptomatic anemia was defined as having following symptoms: i. Fatigue; ii. Weakness; iii. Shortness of breath; iv. Palpitations, fast heartbeat; v. Light headedness and/or vi. Chest pain. Percentage of participants with solicited symptomatic anemia symptoms was reported in this outcome measure. | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]) and placebo in Part A. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Change from baseline (Week 0) in Hgb levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43,45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83,85,87, 89,91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147,149,151,153, 155,157,159,161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. Early Termination (ET) visit/safety follow up (SFU) visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. | Analyzed on Part B-FAS which included all participants who enrolled in Part B and received at least 1 dose (including partial dose) of study drug (BIVV009). Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Mean | Standard Deviation | grams per deciliter | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Change from baseline (Week 0) in total bilirubin levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65,67,69,71,73,75, 77, 79, 81,83, 85, 87, 89, 91, 93, 95, 97, 99,101,103, 105, 107,109, 111,113,115,117,119, 121, 123, 125, 127,129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Here, "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. | Analysis was performed on Part B-FAS. Here, 'overall number of participants analyzed'=participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Mean | Standard Deviation | micromoles per liter | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Each Specified Time Points | FACIT-Fatigue scale consists of 13 questions assessed using a 5-point scale (0=not at all; 1 = a little bit, 2 = somewhat, 3 = quite a bit and 4 = very much). Responses to each question were added to obtain a total score. The Total score ranged from 0 to 52, with higher score indicating more fatigue. Baseline (Week 0) was defined as the last non-missing value prior to the first administration of study drug in Part A. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). | Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Change From Baseline in 12-Item Short-Form Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Each Specified Time Points | SF-12: 12 item-questionnaire assessed health-related quality of life (HRQOL), contained 12 items, categorized into 8 domains (subscales) of functioning and well-being: physical functioning, role-physical, role emotional, mental health, bodily pain, general health, vitality and social functioning, with each domain score ranged from 0 (poor health) to 100 (better health). Higher scores = good health condition. These 8 domains were further summarized into 2 summary scores, PCS and MCS that ranged from 0 (poor health) to 100 (better health). Higher scores = better HRQOL. Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184). | Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Change From Baseline in 5-level European Quality of Life 5- Dimensions 5-Level Questionnaire (EQ-5D-5L) Health State Utility Index and VAS Scores at Each Specified Time Points | EQ-5D-5L included 2 components: health state utility index (descriptive system) and Visual Analog Scale (VAS). EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response option: no problem, slight problem, moderate problem, severe problem and extreme problems measured with Likert scale. EQ-5D-5L responses converted into single index utility score between 0 to 1. Higher score=better health. EQ-5D-5L VAS rated participant's current health state on scale from 0 (worst imaginable health) to 100 (best imaginable health). Baseline (Week 0): last non-missing value prior to first administration of study drug in Part A. ET visit/SFU visit: 9 weeks after administration of last dose (i.e., up to Week 184). | Analysis was performed on Part B-FAS. Here, 'number analyzed'=participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Each Specified Time Points | The PGIS is a self-reported scale. The PGIS is a 1-item questionnaire designed to assess participant's impression of disease severity using a 5-point scale ranging from 1 to 5, where 1=none, 2=mild, 3=moderate, 4=severe, 5=very severe. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Count of Participants | Participants | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Each Specified Time Points | PGIC is a self-administered questionnaire to evaluate the improvement or worsening compared to the start of the study. PGIC was assessed on a 7-point Likert scale ranged from 1 (greatly improved) to 7 (greatly worsened). Categories were defined based on the PGIC scores as follows: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse and 7=very much worsen. Higher scores indicated greater severity. ET visit/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Count of Participants | Participants | Baseline (Week 0), Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147, 159, 171 and ET Visit/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points | Change from baseline (Week 0) in LDH levels at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97, 99, 101, 103, 105, 107,109, 111, 113, 115, 117, 119, 121,123, 125, 127,129,131,133,135,137,139,141,143,145,147, 149, 151,153,155,157,159,161,163,165,167,169, 171, 173, 175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Mean | Standard Deviation | units per liter | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Number of Blood Transfusions Per Participant | A participant was to receive a transfusion if his or her Hgb level met either of the following criteria: Hgb was <9 g/dL and the participant had symptoms of anemia or Hgb was <7 g/dL and the participant was asymptomatic. | Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Mean | Standard Deviation | blood transfusions per participant | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) |
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| Secondary | Part B: Mean Change From Baseline in Haptoglobin Values at Each Specified Time Points | Change from baseline (Week 0) in haptoglobin values at each specified time points (i.e., Week 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57, 59, 61, 63, 65, 67, 69, 71, 73, 75, 77, 79, 81, 83, 85, 87, 89, 91, 93, 95, 97,99,101,103, 105, 107,109, 111,113,115,117,119, 121,123, 125, 127, 129,131,133,135,137,139,141,143, 145,147,149,151,153,155,157,159, 161,163,165,167,169,171,173,175 and ET/SFU Visit) is reported in this outcome measure. Baseline was defined as the last non-missing value prior to the first administration of study drug in Part A. ET/SFU visit was 9 weeks after administration of last dose (i.e., up to Week 184). Haptoglobin values <0.2 were imputed as 0.2. | Analysis was performed on Part B-FAS. Here, 'number analyzed' = participants with available data for each specified category and "0" in the number analyzed field signifies that none of participants were available for assessment at the specified timepoints. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Mean | Standard Deviation | grams per liter | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) |
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| Secondary | Part B: Number of Healthcare Visits by Type | In this outcome measure, number of healthcare visits which included non-study healthcare resource utilization visit (consisted mainly of extra visits to the office of the study doctor, visit to a generalist doctor or visit to a specialist doctor), hospitalization visit and visit to hospital emergency is reported. | Analysis was performed on Part B-FAS. Data for this outcome measure was planned to be collected and analyzed for combined population of BIVV009 (i.e., all participants who received BIVV009 [either 6.5 g or 7.5 g]). | Posted | Number | visits | From Week 27 up to 149 weeks of treatment (i.e., up to Week 176) |
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Part A (both 6.5 g and 7.5 g cohorts): first dose (Day 0) up to Week 25; Part B, 6.5 g cohort: From first dose (Week 26) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 184); Part B, 7.5 g cohort: From first dose (Week 26) up to 137 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 172)
Reported AEs and SAEs including fatal AEs were TEAEs that developed/worsened or became serious during on-treatment period. Analysis was performed on SAS.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: BIVV009 6.5 g | Participants with primary CAD and body weight <75 kg and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 6.5 g on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. | 0 | 17 | 2 | 17 | 16 | 17 |
| EG001 | Part A: BIVV009 7.5 g | Participants with primary CAD and body weight >=75 kg and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of BIVV009 7.5 g on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. | 0 | 5 | 1 | 5 | 5 | 5 |
| EG002 | Part A: Placebo | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. | 0 | 20 | 0 | 20 | 3 | 20 |
| EG003 | Part B: BIVV009 6.5 g | Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 149 weeks. Participants who received placebo in Part A received BIVV009 6.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 6.5 g in Part A received placebo on Week 26, BIVV009 6.5 g on Week 27 and every 2 weeks thereafter for up to an additional 149 weeks. | 1 | 32 | 6 | 32 | 28 | 32 |
| EG004 | Part B: BIVV009 7.5 g | Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 137 weeks. Participants who received placebo in Part A received BIVV009 7.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 7.5 g in Part A received placebo on Week 26, BIVV009 7.5 g on Week 27 and every 2 weeks thereafter for up to an additional 137 weeks. | 0 | 7 | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Polycystic Liver Disease | Congenital, familial and genetic disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Febrile Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Immunoglobulin M Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Squamous Cell Carcinoma Of Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Cerebral Venous Sinus Thrombosis | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Raynaud's Phenomenon | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Loss Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Visual Acuity Reduced | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Angular Cheilitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Faeces Discoloured | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tongue Ulceration | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Catheter Site Dryness | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection Site Pruritus | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination Site Erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination Site Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination Site Rash | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Biliary Colic | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Skin Candida | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Staphylococcal Skin Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Vulval Abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Face Injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Infusion Related Reaction | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Vaccination Complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Immunoglobulin M Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood Urine Present | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bone Swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Melanocytic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Phantom Limb Syndrome | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Device Kink | Product Issues | MedDRA 24.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Depressed Mood | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemoglobinuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Renal Cyst | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Breast Calcifications | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Breast Cyst | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Skin Discolouration | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Toxic Skin Eruption | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cyanosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Extremity Necrosis | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Poor Venous Access | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Raynaud's Phenomenon | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2020 | Dec 1, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000744 | Anemia, Hemolytic, Autoimmune |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634098 | sutimlimab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Other |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Part B: BIVV009 7.5 g | Participants who completed Part A per protocol through the end of treatment visit (Week 26) were eligible to be enrolled in Part B where they were treated for up to an additional 137 weeks. Participants who received placebo in Part A received BIVV009 7.5 g on Week 26, Week 27 and every 2 weeks thereafter; participants who received BIVV009 7.5 g in Part A received placebo on Week 26, BIVV009 7.5 g on Week 27 and every 2 weeks thereafter for up to an additional 137 weeks. |
|
|
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25.
|
|
|
| OG001 |
| Placebo |
Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. |
|
|
|
|
|
|
|
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
|
|
| OG001 | Placebo/BIVV009 | Participants with primary CAD and without a recent history of blood transfusion during the last 6 months prior to enrollment in this study, received an IV infusion of placebo matched to BIVV009 on Day 0 and Day 7 and every 14 days thereafter in Part A up to Week 25. Participants who completed Part A per protocol through the end of treatment visit (Week 26) received BIVV009 6.5 (if <75 kg) or 7.5 g (if >=75 kg) in Part B, on Week 26 and Week 27 and every 2 weeks thereafter for up to an additional 123 weeks (for 6.5 g) or 137 weeks (for 7.5 g). All participants who completed Part A elected to continue in Part B. |
|
|
|
|