Japanese CAD patients get continued access to experimental drug sutimlimab

NCT ID NCT05132127

Completed Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study gave sutimlimab to 7 adults in Japan with cold agglutinin disease (CAD) who had already completed earlier trials and still needed treatment. The goal was to monitor safety and side effects over time until the drug became commercially available. It is a small, open-label study focused on long-term safety.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: sutimlimab
What this could lead to: If successful, this could confirm sutimlimab as a safe long-term treatment option for cold agglutinin disease in Japan.
What could go wrong: This is a small, open-label study with only 7 participants, so results may not apply broadly. It focuses on safety, not effectiveness, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia cold agglutinin disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COLD AGGLUTININ DISEASE

Contacts and locations

Locations

Investigational Site Number 3920001

Tokyo, 113-8431, Japan
Investigational Site Number 3920002

Saitama, 350-0495, Japan
Investigational Site Number 3920003

Osaka, 565-0871, Japan
Investigational Site Number 3920004

Kanagawa, 259-1193, Japan
Investigational Site Number 3920005

Ishikawa, 920-8530, Japan

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