Experimental drug ANX005 targets blood cell destruction in autoimmune anemia
NCT ID NCT04691570
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This phase 2 trial investigates ANX005, an investigational drug given intravenously, for people with warm autoimmune hemolytic anemia (wAIHA). The study aims to assess the safety and tolerability of repeated doses, and to measure changes in blood markers like hemoglobin and bilirubin. Participants are adults with confirmed wAIHA and low hemoglobin levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ANX005
- What this could lead to
- If successful, ANX005 could offer a new treatment option for people with warm autoimmune hemolytic anemia, potentially improving red blood cell counts and reducing disease symptoms.
- What could go wrong
- This is a small, early-phase trial with only 7 participants, so results may not apply broadly. The drug may cause side effects or fail to show meaningful benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
7 people
The number who actually took part.
- Started
-
Nov 2021
- Finished
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Jan 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Investigational Site 01
Rochester, Minnesota, 55905, United States
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Investigational Site 02
Sofia, Bulgaria
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Investigational Site 03
Melbourne, Australia
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Investigational Site 04
Vienna, Austria
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