# 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** · PHASE3 · COMPLETED · sponsor: **Bioverativ, a Sanofi company** · enrollment: 24 (actual)

## Conditions studied

- Agglutinin Disease, Cold

## Interventions

- **DRUG:** BIVV009

## Key facts

- **NCT ID:** NCT03347396
- **Lead sponsor:** Bioverativ, a Sanofi company
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-03-05
- **Primary completion:** 2021-10-05
- **Final completion:** 2021-10-05
- **Target enrollment:** 24 (ACTUAL)
- **Last updated:** 2022-10-31


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03347396

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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)". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT03347396. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*