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

Overview

About this study

The purpose of this study is to evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Eligibility last updated 6/24/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ronald Go, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Lindsey Kluck APRN, C.N.P., M.S.N.

Kluck.Lindsey@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20523804

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