# A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

> **NCT04058158** · PHASE3 · COMPLETED · sponsor: **Samsung Bioepis Co., Ltd.** · enrollment: 50 (actual)

## Conditions studied

- Paroxysmal Nocturnal Hemoglobinuria

## Interventions

- **DRUG:** SB12 (proposed eculizumab biosimilar)
- **DRUG:** Soliris (eculizumab)

## Key facts

- **NCT ID:** NCT04058158
- **Lead sponsor:** Samsung Bioepis Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-08-07
- **Primary completion:** 2021-09-21
- **Final completion:** 2021-10-21
- **Target enrollment:** 50 (ACTUAL)
- **Last updated:** 2024-03-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04058158

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04058158, "A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04058158. Licensed CC0.

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