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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03347396
Registration number
NCT03347396
Ethics application status
Date submitted
16/11/2017
Date registered
20/11/2017
Date last updated
31/10/2022
Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
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Scientific title
A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion
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Secondary ID [1]
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BIVV009-03
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Secondary ID [2]
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EFC16215
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Agglutinin Disease, Cold
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Condition category
Condition code
Blood
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Anaemia
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Inflammatory and Immune System
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BIVV009
Experimental: BIVV009 - Participants with primary CAD who had a recent history of transfusion (defined as at least 1 transfusion during the last 6 months prior to screening) received an intravenous (IV) infusion of BIVV009 6.5 grams (g) (if body weight was less than [<] 75 kilograms [kg]) or BIVV009 7.5 g (if body weight was 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) could continue to receive BIVV009 in Part B, every 2 weeks starting at Week 27 for up to an additional 149 weeks. All participants who completed Part A elected to continue in Part B.
Treatment: Drugs: BIVV009
Sutimlimab was administered as intravenous (IV) infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Percentage of Participants With Response to Treatment
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Assessment method [1]
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A participant was considered a responder: if he or she did not receive a blood transfusion from Week 5 through Week 26 (end of treatment in Part A) and did not receive treatment for CAD beyond what was permitted per protocol. Additionally, the participant's hemoglobin (Hgb) level must meet either of the following criteria: Hgb level >= 12 grams per deciliter (g/dL) at the treatment assessment endpoint (defined as the average of the values from the Week 23, 25, and 26 visits), or Hgb increased >= 2 g/dL from baseline (defined as the last Hgb value before administration of the first dose of study drug) at treatment assessment endpoint. Percentage of responders was calculated together with a 95% exact Clopper-Pearson confidence interval (CI).
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Timepoint [1]
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From Week 5 through Week 26
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Primary outcome [2]
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Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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Assessment method [2]
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An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. 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 a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent (TE) period (from the first investigational medicinal product [IMP] administration in Part B to the last IMP administration + 9 weeks follow up period).
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Timepoint [2]
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Part B, 6.5 g cohort: From first dose (Week 27) up to 143 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 179); Part B, 7.5 g cohort: From first dose (Week 27) up to 149 weeks of treatment + 9 weeks of follow-up (i.e., up to Week 185)
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Secondary outcome [1]
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Part A: Mean Change From Baseline in Bilirubin Levels at the Treatment Assessment Timepoint
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Assessment method [1]
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Mean change from baseline in bilirubin levels at the treatment assessment timepoint was 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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Timepoint [1]
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Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
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Secondary outcome [2]
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Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Treatment Assessment Timepoint
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Assessment method [2]
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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 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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Timepoint [2]
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Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
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Secondary outcome [3]
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Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint
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Assessment method [3]
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Mean change from baseline 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. LS mean and 95% CI was assessed by MMRM approach using 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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Timepoint [3]
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Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
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Secondary outcome [4]
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Part A: Number of Blood Transfusions Per Participant
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Assessment method [4]
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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. Number of transfusions after the first 5 weeks of study drug administration and up to Week 26 are reported in this outcome measure.
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Timepoint [4]
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From Week 5 up to Week 26
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Secondary outcome [5]
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Part A: Number of Blood Units Transfused Per Participant
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Assessment method [5]
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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. Number of blood units transfused after the first 5 weeks of study drug administration and up to Week 26 are reported in this outcome measure.
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Timepoint [5]
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From Week 5 up to Week 26
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Secondary outcome [6]
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Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint
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Assessment method [6]
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Mean change from baseline (Week 0) in Hgb at 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. LS mean and 95% CI was assessed by MMRM approach using 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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Timepoint [6]
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Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26)
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Secondary outcome [7]
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Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points
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Assessment method [7]
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Change From Hgb level from baseline (Week 0) at each specified time points (i.e., Weeks 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, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175 and early termination/safety follow up [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 185).
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Timepoint [7]
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Baseline, Weeks 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, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175, ET/SFU (up to Week 185)
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Secondary outcome [8]
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Part B: Change From Baseline in Bilirubin Levels at Each Specified Time Points
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Assessment method [8]
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Change from baseline (Week 0) in bilirubin levels at each specified time point (i.e., Weeks 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, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 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 185).
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Timepoint [8]
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Baseline, Weeks 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, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175, ET/SFU (up to Week 185)
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Secondary outcome [9]
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Part B: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and Early Termination (ET) Visit/Safety Follow-up Visit
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Assessment method [9]
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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 185).
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Timepoint [9]
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Baseline, Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and ET Visit/SFU visit (i.e., up to Week 185)
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Secondary outcome [10]
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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
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Assessment method [10]
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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 for which, score ranged 0 (poor health) to 100 (better health). Higher scores = better HRQOL. Baseline (Week 0) was defined as the last non-missing value prior to 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 185). Change from baseline in SF-12 PCS and MCS scores is reported in this outcome measure.
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Timepoint [10]
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Baseline, Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135 and ET Visit/SFU visit (i.e., up to Week 185)
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Secondary outcome [11]
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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 Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and ET Visit/SFU Visit
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Assessment method [11]
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EQ-5D-5L:standardized, participant-rated questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L 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 problems, slight problems, moderate problems, severe problems, and extreme problems measured with Likert scale. EQ-5D-5L responses relating to 5 dimensions are converted into a single index utility score between 0 to 1, where higher score=better health state. The EQ-5D-5L VAS rated participant's current health state on a scale from 0=worst imaginable health state to 100 =best imaginable health state. Baseline (Week 0): last non-missing value prior to 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 185).
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Timepoint [11]
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Baseline, Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and ET Visit/SFU visit (i.e., up to Week 185)
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Secondary outcome [12]
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Part B: Number of Participants With Response to Participant's Global Impression of (Fatigue) Severity (PGIS) Questionnaire at Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and at ET Visit/SFU Visit
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Assessment method [12]
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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 185).
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Timepoint [12]
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At Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and at ET Visit/SFU visit (i.e., up to Week 185)
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Secondary outcome [13]
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Part B: Number of Participants With Response to Participant's Global Impression of Change (PGIC) Questionnaire at Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and at ET Visit/SFU Visit
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Assessment method [13]
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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 185).
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Timepoint [13]
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At Weeks 39, 51, 63, 75, 87, 99, 111, 123, 135, 147,159, 171 and at ET Visit/SFU visit (i.e., up to Week 185)
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Secondary outcome [14]
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Part B: Mean Change From Baseline in Lactate Dehydrogenase (LDH) Level at Each Specified Time Points
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Assessment method [14]
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Mean change from baseline in LDH levels at each specified time points (i.e., Weeks 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, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175 and ET/SFU Visit) is reported in this outcome measure. 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 185).
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Timepoint [14]
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Baseline, Weeks 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, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175, ET/SFU (up to Week 185)
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Secondary outcome [15]
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Part B: Number of Blood Transfusions Per Participant
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Assessment method [15]
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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.
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Timepoint [15]
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From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)
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Secondary outcome [16]
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Part B: Number of Blood Units Transfused Per Participant
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Assessment method [16]
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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.
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Timepoint [16]
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From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)
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Secondary outcome [17]
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Part B: Change From Baseline in Haptoglobin Values at Each Specified Time Points
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Assessment method [17]
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Change in Haptoglobin values from baseline at each specified time points (i.e., Weeks 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, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 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 185). Haptoglobin values <0.2 were imputed as 0.2.
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Timepoint [17]
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Baseline, Weeks 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, 83, 87, 91, 95, 99, 103, 107, 111, 115, 119, 123, 127, 131, 135, 139, 143, 147, 151, 155, 159, 163, 167, 171, 175, ET/SFU (up to Week 185)
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Secondary outcome [18]
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Part B: Number of Healthcare Visits by Type
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Assessment method [18]
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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, or visit to a generalist doctor, or visit to a specialist doctor) and hospitalization visit and visit to hospital emergency is reported.
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Timepoint [18]
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From Week 27 up to 149 weeks of treatment (i.e., up to Week 176)
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Eligibility
Key inclusion criteria
- Body weight of >= 39 kg at screening.
- Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic
hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific
DAT strongly positive for C3d; d) Cold agglutinin titer >= 64 at 4 degree celsius; e)
Immunoglobulin G (IgG) DAT less than or equal to (<=) 1+, and f) No overt malignant
disease.
- History of at least one documented blood transfusion within 6 months of enrollment.
- Hemoglobin level <= 10.0 g/dL.
- Bilirubin level above the normal reference range, including participants with
Gilbert's Syndrome.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active
hematologic malignancy.
- Clinically relevant infection of any kind within the month preceding enrollment (e.g.,
active hepatitis C, pneumonia).
- Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with
anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long-standing
duration without associated clinical symptoms adjudicated on a case-by-case basis
during the Confirmatory Review of Patient Eligibility.
- Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C
virus antibody) prior to or at Screening.
- Positive human immunodeficiency virus (HIV) antibody at screening.
- Treatment with rituximab monotherapy within 3 months or rituximab combination
therapies (e.g., with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within
6 months prior to enrollment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/10/2021
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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USC Health Clinics - Buderim
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Recruitment hospital [2]
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Ballarat Oncology & Haematology - Ballarat
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Recruitment hospital [3]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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4556 - Buderim
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Recruitment postcode(s) [2]
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3350 - Ballarat
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
District of Columbia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Massachusetts
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New York
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Country [6]
0
0
United States of America
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State/province [6]
0
0
North Carolina
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Ohio
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Pennsylvania
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Wisconsin
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Country [10]
0
0
Austria
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State/province [10]
0
0
Vienna
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Antwerpen
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Country [12]
0
0
Belgium
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State/province [12]
0
0
La Louvière
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Country [13]
0
0
Belgium
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State/province [13]
0
0
Leuven
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Country [14]
0
0
Canada
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State/province [14]
0
0
Ontario
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Country [15]
0
0
Canada
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State/province [15]
0
0
Quebec
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Country [16]
0
0
Canada
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State/province [16]
0
0
Edmonton
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Country [17]
0
0
France
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State/province [17]
0
0
Caen
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Country [18]
0
0
France
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State/province [18]
0
0
Créteil
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Country [19]
0
0
France
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State/province [19]
0
0
Lyon
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Country [20]
0
0
Germany
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State/province [20]
0
0
Dresden
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Country [21]
0
0
Germany
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State/province [21]
0
0
Essen
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Country [22]
0
0
Germany
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State/province [22]
0
0
Ulm
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Country [23]
0
0
Israel
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State/province [23]
0
0
Jerusalem
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Country [24]
0
0
Israel
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State/province [24]
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Netanya
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Country [25]
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Israel
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Tel Aviv
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Italy
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Brescia
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Italy
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Milan
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Italy
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Rome
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Italy
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Vicenza
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Japan
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Kanagawa
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Japan
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Saitama-Ken
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Japan
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Tokyo-To
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Netherlands
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Amsterdam
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Norway
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Bergen
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Norway
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Oslo
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Norway
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Trondheim
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Sevilla
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Spain
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Valencia
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United Kingdom
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Leeds
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bioverativ, a Sanofi company
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Ethics approval
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Summary
Brief summary
The purpose of Part A was to determine whether sutimlimab administration resulted in a
greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb)
levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during
treatment in participants with primary cold agglutinin disease (CAD) who had 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 CAD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03347396
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03347396
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