Trial · NCT03347396
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)
NCT03347396, Phase 3, Completed, Bioverativ, a Sanofi company; results first posted 2022-10-31
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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). Trials, record NCT03347396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03347396
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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)
- NCT number
- NCT03347396
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 24 participants, actual
- Lead sponsor
- Bioverativ, a Sanofi company
- Conditions
- Agglutinin Disease, Cold
- Interventions
- BIVV009
- First posted
- 2017-11-20
- Last updated
- 2022-10-31
- Other registries' IDs
- eudract:2017-003538-10
- Results first posted
- 2022-10-31
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Percentage of Participants With Response to Treatment | From Week 5 through Week 26 | 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). |
| Primary | Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | 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) | 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). |
| Secondary | Part A: Mean Change From Baseline in Bilirubin Levels at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. |
| Secondary | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. |
| Secondary | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. |
| Secondary | Part A: Number of Blood Transfusions Per Participant | From Week 5 up to Week 26 | 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. |
| Secondary | Part A: Number of Blood Units Transfused Per Participant | From Week 5 up to Week 26 | 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. |
| Secondary | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. |
| Secondary | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | 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) | 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). |
| Secondary | Part B: Change From Baseline in Bilirubin Levels at Each Specified Time Points | 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) | 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). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Percentage of Participants With Response to Treatment | From Week 5 through Week 26 | Analysis was performed on Part A-full analysis set (FAS) which included all participants who received at least 1 dose (including partial dose) of study drug. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | percentage of participants | NUMBER |
| PRIMARY | Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | 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) | Analysis was performed 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 for dose-wise reporting groups (BIVV009 6.5g and BIVV009 7.5 g). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Mean Change From Baseline in Bilirubin Levels at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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 (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | micromoles per Liter (mcmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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 (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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 (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | units per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Number of Blood Transfusions Per Participant | From Week 5 up to Week 26 | 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 (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | blood transfusions per participant | MEAN |
| SECONDARY | Part A: Number of Blood Units Transfused Per Participant | From Week 5 up to Week 26 | Analysis was performed on Part A-FAS. Here, 'overall number of participants analyzed' = number of participants with at least 1 transfusion. Data for this outcome measure was planned to be collected and analyzed for combined population (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | blood units transfused per participant | MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Baseline, treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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 (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | g/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | 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) | Analysis was performed on Part B-FAS which included all participants who enrolled in Part B study and received at least 1 dose (including partial dose) of study drug. 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 (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | g/dL | MEAN |
| SECONDARY | Part B: Change From Baseline in Bilirubin Levels at Each Specified Time Points | 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) | 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 (i.e., all participants who received BIVV009 \[either at 6.5 g or 7.5 g\]). | mcmol/L | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group439
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Percentage of Participants With Response to Treatment | BIVV009 | 54.2 | 95% Confidence Interval 32.8 to 74.4 | percentage of participants | |
| Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | BIVV009 6.5 g | TEAEs | 16 | Participants | |
| Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | BIVV009 7.5 g | TEAEs | 6 | Participants | |
| Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | BIVV009 6.5 g | TESAEs | 10 | Participants | |
| Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | BIVV009 7.5 g | TESAEs | 2 | Participants | |
| Part A: Mean Change From Baseline in Bilirubin Levels at the Treatment Assessment Timepoint | BIVV009 | -38.18 | 95% Confidence Interval -42.52 to -33.84 | micromoles per Liter (mcmol/L) | |
| Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score (Quality of Life) at Treatment Assessment Timepoint | BIVV009 | 10.85 | 95% Confidence Interval 8.00 to 13.70 | score on a scale | |
| Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | BIVV009 | -126.95 | 95% Confidence Interval -218.47 to -35.42 | units per liter | |
| Part A: Number of Blood Transfusions Per Participant | BIVV009 | 0.9 | Standard Deviation 2.75 | blood transfusions per participant | |
| Part A: Number of Blood Units Transfused Per Participant | BIVV009 | 5.8 | Standard Deviation 8.47 | blood units transfused per participant |
1 to 10 of 439Source ClinicalTrials.gov
See all 439 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (26 Weeks) | STARTED | BIVV009 6.5 g | 17 | |
| Part A (26 Weeks) | STARTED | BIVV009 7.5 g | 7 | |
| Part A (26 Weeks) | COMPLETED | BIVV009 6.5 g | 16 | |
| Part A (26 Weeks) | COMPLETED | BIVV009 7.5 g | 6 | |
| Part A (26 Weeks) | NOT COMPLETED | BIVV009 6.5 g | 1 | |
| Part A (26 Weeks) | NOT COMPLETED | BIVV009 7.5 g | 1 | |
| Part B (149 Weeks) | STARTED | BIVV009 6.5 g | 16 | |
| Part B (149 Weeks) | STARTED | BIVV009 7.5 g | 6 | |
| Part B (149 Weeks) | COMPLETED | BIVV009 6.5 g | 14 | |
| Part B (149 Weeks) | COMPLETED | BIVV009 7.5 g | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,084
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: BIVV009 6.5 g | 0 | 17 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BIVV009 7.5 g | 1 | 7 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: BIVV009 6.5 g | 5 | 16 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: BIVV009 7.5 g | 2 | 6 | 2 |
| other | Cold Type Haemolytic Anaemia | Blood and lymphatic system disorders | Part A: BIVV009 6.5 g | 0 | 17 | 0 |
| other | Cold Type Haemolytic Anaemia | Blood and lymphatic system disorders | Part A: BIVV009 7.5 g | 0 | 7 | 0 |
| other | Cold Type Haemolytic Anaemia | Blood and lymphatic system disorders | Part B: BIVV009 6.5 g | 2 | 16 | 2 |
| other | Cold Type Haemolytic Anaemia | Blood and lymphatic system disorders | Part B: BIVV009 7.5 g | 0 | 6 | 0 |
| other | Haemolysis | Blood and lymphatic system disorders | Part A: BIVV009 6.5 g | 0 | 17 | 0 |
| other | Haemolysis | Blood and lymphatic system disorders | Part A: BIVV009 7.5 g | 0 | 7 | 0 |
1 to 10 of 1,084Source ClinicalTrials.gov
See all 1,084 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: BIVV009 6.5 g | 0 | 17 |
| Total, all-cause mortality | Part A: BIVV009 7.5 g | 1 | 7 |
| Total, all-cause mortality | Part B: BIVV009 6.5 g | 2 | 16 |
| Total, all-cause mortality | Part B: BIVV009 7.5 g | 0 | 6 |
| Total, other adverse events | Part A: BIVV009 6.5 g | 15 | 17 |
| Total, other adverse events | Part A: BIVV009 7.5 g | 6 | 7 |
| Total, other adverse events | Part B: BIVV009 6.5 g | 16 | 16 |
| Total, other adverse events | Part B: BIVV009 7.5 g | 6 | 6 |
| Total, serious adverse events | Part A: BIVV009 6.5 g | 4 | 17 |
| Total, serious adverse events | Part A: BIVV009 7.5 g | 3 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03347396
GET https://conductscience.org/api/trials/v1/NCT03347396/results?page=2