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

Completed · Phase 2

Conditions studied: Warm Autoimmune Hemolytic Anemia (wAIHA)

In brief

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

Key facts

Study ID

NCT04691570

Run by

Annexon, Inc.

People needed

7

Starts

2021-11-10

Expected to finish

2023-01-17

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Investigational Site 01 — Rochester, Minnesota, United States
• Investigational Site 03 — Melbourne, Australia
• Investigational Site 04 — Vienna, Austria
• Investigational Site 02 — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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