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

• Status: Not yet recruiting
• Trial end date: 2022-02-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Annexon, Inc.

Criteria

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.

• Hemoglobin (Hgb) level <10.0 g /dL (pre-transfusion).

• Positive direct antiglobulin test (DAT) ≥ 1+ for C3d and immunoglobulin G (IgG).

• Evidence of classical complement pathway activation.

• CH50 below the lower limit of normal.

• 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 complete vaccinations at least 2 weeks prior to dosing with ANX005.

Exclusion Criteria:

• Elevated aspartate aminotransferase or alanine aminotransferase levels >2.5 times the upper limit of normal.

• Platelet count < 30 X 10^9/L.

• 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 kg or greater than 100 kg.