Trial · NCT05132127
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
NCT05132127, Phase 3, Completed, Sanofi; results first posted 2023-10-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan. Trials, record NCT05132127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05132127
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
- NCT number
- NCT05132127
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Cold Agglutinin Disease
- Interventions
- sutimlimab
- First posted
- 2021-11-24
- Last updated
- 2025-09-15
- Results first posted
- 2023-10-03
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study intervention and did not necessarily had to have a causal relationship with the treatment. Serious adverse events (SAEs) were 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, suspected transmission of any infectious agent via an authorized medicinal product, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent period (from first dose of study intervention up to 9 weeks after the last dose of study intervention in the current study). |
| Primary | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks) | An AE was defined as any untoward medical occurrence in a participant who received study intervention and did not necessarily had to have a causal relationship with the treatment. AESIs were AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks) | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | From first dose of study intervention up to 9 weeks after the last dose of study intervention (maximum duration: 49 weeks) | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Sutimlimab | TEAEs | 7 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Sutimlimab | TESAEs | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI) | Sutimlimab | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sutimlimab | 7 | |
| Overall Study | COMPLETED | Sutimlimab | 6 | |
| Overall Study | NOT COMPLETED | Sutimlimab | 1 |
Source ClinicalTrials.gov
Adverse events32
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 | Cystitis | Infections and infestations | Sutimlimab | 1 | 7 | 2 |
| other | Gingivitis | Infections and infestations | Sutimlimab | 1 | 7 | 1 |
| other | Nasopharyngitis | Infections and infestations | Sutimlimab | 1 | 7 | 1 |
| other | Rhinitis | Infections and infestations | Sutimlimab | 1 | 7 | 1 |
| other | Skin Candida | Infections and infestations | Sutimlimab | 1 | 7 | 1 |
| other | Urinary Tract Infection | Infections and infestations | Sutimlimab | 1 | 7 | 1 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Sutimlimab | 1 | 7 | 1 |
| other | Hypothyroidism | Endocrine disorders | Sutimlimab | 1 | 7 | 1 |
| other | Hypoglycaemia | Metabolism and nutrition disorders | Sutimlimab | 1 | 7 | 1 |
| other | Insomnia | Psychiatric disorders | Sutimlimab | 1 | 7 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sutimlimab | 1 | 7 |
| Total, other adverse events | Sutimlimab | 7 | 7 |
| Total, serious adverse events | Sutimlimab | 1 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05132127
GET https://conductscience.org/api/trials/v1/NCT05132127/events?page=2