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Japanese CAD patients get continued access to experimental drug sutimlimab

NCT ID NCT05132127

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

7 people

The number who actually took part.

Started

Nov 2021

Finished

Nov 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: --Participant must be adults. * Participants who had been enrolled in and had completed Part B of CARDINAL or CADENZA study. * Participants who had ongoing diagnosis of CAD. * Participants who continued to require treatment for CAD upon completion of participation in the previous study evidenced by return of CAD-related symptoms of anemia and/or deterioration on markers of hemolysis after the end of study visit following the 9-week safety follow up period. (9-week follow up period). * Participants who had acceptable benefit/risk profile. * Participant who had acceptable infection risk. * Participants who had no available appropriate alternative therapy for CAD. * Body weight \>= 39 kg. * Gave signed informed consent. Exclusion Criteria: --Clinical diagnosis of systemic lupus erythematosus or immune complex-mediated autoimmune disorders. * Participants who met recent Rituximab and/or immunosuppressive therapy. * Any of the following medical conditions: 1. Active, serious intercurrent illness which precluded enrolment until recovery was complete. 2. Pregnancy or breast-feeding. * End of Study visit in CARDINAL or CADENZA took place more than 3 months before Baseline visit in this study. * Hypersensitivity reactions to sutimlimab or components thereof, or other allergy that, in the opinion of the Investigator, contraindicated participation in the study.

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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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