Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
Lead Sponsor:
Annexon, Inc.
Conditions:
Warm Autoimmune Hemolytic Anemia (wAIHA)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
Detailed 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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04691570
Start Date
November 10 2021
End Date
January 17 2023
Last Update
January 19 2024
Active Locations (1)
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1
Investigational Site 01
Rochester, Minnesota, United States, 55905