# 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** · PHASE3 · COMPLETED · sponsor: **Bioverativ, a Sanofi company** · enrollment: 42 (actual)

## Conditions studied

- Cold Agglutinin Disease

## Interventions

- **DRUG:** sutimlimab (BIVV009)
- **DRUG:** placebo

## Key facts

- **NCT ID:** NCT03347422
- **Lead sponsor:** Bioverativ, a Sanofi company
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-03-17
- **Primary completion:** 2021-12-03
- **Final completion:** 2021-12-03
- **Target enrollment:** 42 (ACTUAL)
- **Last updated:** 2022-12-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03347422

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT03347422. Licensed CC0.

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