Trial · NCT03347422
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion
NCT03347422, Phase 3, Completed, Bioverativ, a Sanofi company; results first posted 2022-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion. Trials, record NCT03347422. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03347422
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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 Without A Recent History of Blood Transfusion
- NCT number
- NCT03347422
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Bioverativ, a Sanofi company
- Conditions
- Cold Agglutinin Disease
- Interventions
- sutimlimab (BIVV009), placebo
- First posted
- 2017-11-20
- Last updated
- 2022-12-23
- Other registries' IDs
- eudract:2017-003539-12
- Results first posted
- 2022-12-23
Source ClinicalTrials.gov
Registered outcomes18
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 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). |
| Primary | Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | 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) | 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). |
| Secondary | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. |
| Secondary | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | Baseline (Week 0), 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 (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. |
| Secondary | Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. |
| Secondary | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. |
| Secondary | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | 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. |
| Secondary | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | 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. |
| Secondary | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | 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. |
| 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 | 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) | 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). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 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. | percentage of participants | NUMBER |
| PRIMARY | Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | 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) | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. | grams per deciliter | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | Baseline (Week 0), treatment assessment timepoint (i.e., average of Week 23, 25 and 26) | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Total Bilirubin Levels at the Treatment Assessment Timepoint | Baseline (Week 0), 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 of BIVV009 (i.e., all participants who received BIVV009 \[either at 6.5 or 7.5 g\] and placebo in Part A. | micromoles per liter | MEAN |
| SECONDARY | Part A: Mean Change From Baseline in Lactate Dehydrogenase (LDH) at the Treatment Assessment Timepoint | Baseline (Week 0), 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 of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]) and placebo in Part A. | units per liter | MEAN |
| SECONDARY | Part A: Percentage of Participants With Solicited Symptomatic Anemia at Week 26 | 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 of BIVV009 (i.e., all participants who received BIVV009 \[either 6.5 g or 7.5 g\]) and placebo in Part A. | percentage of participants | NUMBER |
| SECONDARY | Part B: Change From Baseline in Hemoglobin (Hgb) Level at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | 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 \[either 6.5 g or 7.5 g\]). | grams per deciliter | MEAN |
| SECONDARY | Part B: Change From Baseline in Total Bilirubin Levels at Each Specified Time Points | Baseline (Week 0), every 2 weeks starting from Week 27 till Week 175 and at ET/SFU visit (i.e., up to Week 184) | 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 \[either 6.5 g or 7.5 g\]). | micromoles per liter | MEAN |
| 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 | 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) | 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 \[either 6.5 g or 7.5 g\]). | score on a scale | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group1,053
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 | 72.7 | 95% Confidence Interval 49.8 to 89.3 | percentage of participants | |
| Part A: Percentage of Participants With Response to Treatment | Placebo | 15.0 | 95% Confidence Interval 3.2 to 37.9 | percentage of participants | |
| Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Part B: BIVV009 6.5 g | TEAEs | 29 | Participants | |
| Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Part B: BIVV009 7.5 g | TEAEs | 7 | Participants | |
| Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Part B: BIVV009 6.5 g | TESAEs | 6 | Participants | |
| Part B: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) | Part B: BIVV009 7.5 g | TESAEs | 1 | Participants | |
| Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | BIVV009 | 2.66 | 95% Confidence Interval 2.09 to 3.22 | grams per deciliter | |
| Part A: Mean Change From Baseline in Hemoglobin (Hgb) Level at the Treatment Assessment Timepoint | Placebo | 0.09 | 95% Confidence Interval -0.50 to 0.68 | grams per deciliter | |
| Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | BIVV009 | 10.83 | 95% Confidence Interval 7.45 to 14.22 | score on a scale | |
| Part A: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at the Treatment Assessment Timepoint | Placebo | 1.91 | 95% Confidence Interval -1.65 to 5.46 | score on a scale |
1 to 10 of 1,053Source ClinicalTrials.gov
See all 1,053 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/BIVV009 | 22 | |
| Part A (26 Weeks) | STARTED | Placebo/BIVV009 | 20 | |
| Part A (26 Weeks) | COMPLETED | BIVV009/BIVV009 | 19 | |
| Part A (26 Weeks) | COMPLETED | Placebo/BIVV009 | 20 | |
| Part A (26 Weeks) | NOT COMPLETED | BIVV009/BIVV009 | 3 | |
| Part A (26 Weeks) | NOT COMPLETED | Placebo/BIVV009 | 0 | |
| Part B (149 Weeks) | STARTED | BIVV009/BIVV009 | 19 | |
| Part B (149 Weeks) | STARTED | Placebo/BIVV009 | 20 | |
| Part B (149 Weeks) | COMPLETED | BIVV009/BIVV009 | 16 | |
| Part B (149 Weeks) | COMPLETED | Placebo/BIVV009 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events775
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 | 2 | 5 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Part A: Placebo | 0 | 20 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: BIVV009 6.5 g | 9 | 32 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Part B: BIVV009 7.5 g | 2 | 7 | 3 |
| other | Blood Loss Anaemia | Blood and lymphatic system disorders | Part A: BIVV009 6.5 g | 1 | 17 | 1 |
| other | Blood Loss Anaemia | Blood and lymphatic system disorders | Part A: BIVV009 7.5 g | 0 | 5 | 0 |
| other | Blood Loss Anaemia | Blood and lymphatic system disorders | Part A: Placebo | 0 | 20 | 0 |
| other | Blood Loss Anaemia | Blood and lymphatic system disorders | Part B: BIVV009 6.5 g | 0 | 32 | 0 |
| other | Blood Loss Anaemia | Blood and lymphatic system disorders | Part B: BIVV009 7.5 g | 0 | 7 | 0 |
1 to 10 of 775Source ClinicalTrials.gov
See all 775 adverse eventsAdverse event totals15
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 | 0 | 5 |
| Total, all-cause mortality | Part A: Placebo | 0 | 20 |
| Total, all-cause mortality | Part B: BIVV009 6.5 g | 1 | 32 |
| Total, all-cause mortality | Part B: BIVV009 7.5 g | 0 | 7 |
| Total, other adverse events | Part A: BIVV009 6.5 g | 16 | 17 |
| Total, other adverse events | Part A: BIVV009 7.5 g | 5 | 5 |
| Total, other adverse events | Part A: Placebo | 3 | 20 |
| Total, other adverse events | Part B: BIVV009 6.5 g | 28 | 32 |
| Total, other adverse events | Part B: BIVV009 7.5 g | 7 | 7 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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.
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