Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

  • STATUS
    Recruiting
  • End date
    Apr 12, 2023
  • participants needed
    12
  • sponsor
    Annexon, Inc.
Updated on 12 July 2022

Summary

This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

Description

After being informed of study details and potential risks, all participants who provide written informed consent will undergo an up to 6-week screening period to determine eligibility. Participants who meet the eligibility criteria will receive two once-weekly intravenous (IV) infusions of ANX005. Participants will return to the clinic weekly through Week 10 for study assessments. The total duration of individual participation in this study will be up to 16 weeks.

Details
Condition Warm Autoimmune Hemolytic Anemia (wAIHA)
Treatment ANX005
Clinical Study IdentifierNCT04691570
SponsorAnnexon, Inc.
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or non-pregnant, non-lactating female ≥18 years of age (no maximum age)
Diagnosis of wAIHA at least 3 months prior to screening with a direct antiglobulin test (DAT) ≥1 positive for immunoglobulin G (IgG)±C3, or a diagnosis of mixed autoimmune hemolytic anemia (AIHA) that is DAT positive for both IgG and C3, with a presence of a cold antibody with a thermal amplitude ≥30ºCelcius
Hemoglobin (Hgb) level ≤10.0 grams/deciliter (pre-transfusion)
Evidence of classical complement pathway activation
Evidence of active hemolysis
Stable use of glucocorticoids and immunosuppressants are permitted
Vaccinations against encapsulated bacterial organisms within 5 years prior to screening or participant must be willing to receive prophylaxis against infections with encapsulated bacteria via vaccination and/or the use of prophylactic antibiotics in accordance with local standards of practice and/or guidelines

Exclusion Criteria

Elevated aspartate aminotransferase or alanine aminotransferase levels >2.5 times the upper limit of normal
Platelet count <30 X 10^9/liter
History of cold agglutinin disease
History of solid organ, bone marrow, or stem cell transplantation
History of splenectomy within the 3 months prior to screening
Received rituximab or other anti-CD20 monoclonal antibody <3 months prior to screening
Intravenous immunoglobulin (IVIg) treatment within 3 months prior to screening or plasmapheresis or immunoadsorption treatment within 60 days prior to screening
Clinically significant, recent, or ongoing illness or medical condition, including coexistent autoimmune disorder, malignancy, HIV, hepatitis B virus, and hepatitis C virus
History of meningitis or septicemia within the past 2 years
Treatment with an investigational therapeutic agent within 30 days prior to screening
Hypersensitivity to any drug product or excipients used in this study or to previous IV medication administration
Body weight less than 50 kilograms (kg) or greater than 100 kg
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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