Ended Human Pharmacology (Phase I)- Other Autoimmune haemolytic anaemia

An open-label, long-term, safety and tolerability study of SAR445088 in participants with cold agglutinin disease previously treated with SAR445088 or never treated with SAR445088

EU CTIS ID: 2023-510210-68-00

What this study is testing

To assess the long-term safety and tolerability in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088

  • Human Pharmacology (Phase I)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male and female adult patients ≥18 years of age with CAD who were previously treated with SAR445088 and met criteria the below criteria for entry into Part 1: • met the eligibility criteria of a previous study evaluating SAR445088; • successfully enrolled and completed dosing in a previous study evaluating SAR445088; • successfully completed end of study procedures in a previous study evaluating SAR445088; and • per Investigator judgement, had a favorable benefit-to-risk profile after receiving SAR445088. OR were never treated with SAR445088 before entering Part 2, and met the below criteria to establish CAD diagnosis: • chronic hemolysis; • polyspecific direct antiglobulin test (DAT) positive status; • monospecific DAT strongly positive for C3d; • cold agglutinin [CAg] titer ≥64 at 4°C; • IgG DAT ≤1+; • hemoglobin level ≤10 g/dL; • elevated bilirubin not attributable to liver disease; Documented vaccinations against encapsulated bacterial pathogens given within five years of enrollment and at least 14 days prior to dosing (vaccinations have to be initiated at least 14 days prior to dosing and completed before Week 5 of Part 2) Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants. Having given written informed consent prior to undertaking any study-related procedure.

You likely can't join if

  • Participants are excluded from the study if any of the following criteria apply: Cold agglutinin syndrome secondary to infection, rheumatologic disease, or known high-grade hematologic malignancy, or known solid organ tumor. Clinically relevant infection within 1 month of enrollment. Clinical diagnosis of systemic lupus erythematosus (SLE). Treatment with anti-CD20 monotherapy within 3 months or anti-CD20 combination therapies within 6 months prior to screening. Concurrent treatment with systemic immunosuppressive agents targeting B- or T-cell function and/or cytotoxic agents within 3 months prior to screening. Concurrent treatment with other systemic immunosuppressants within 5.5 half-lives of the drug prior to screening. Any specific complement system inhibitor other than SAR445088 (eg, eculizumab) within 3 months prior to screening. Concurrent treatment with systemic corticosteroids other than a stable daily dose equivalent to ≤10 mg/day prednisone within 3 months prior to screening. History of hypersensitivity to SAR445088 or any of its components.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.