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Experimental drug ANX005 targets blood cell destruction in autoimmune anemia

NCT ID NCT04691570

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

  • Investigational Site 02

    Sofia, Bulgaria

  • Investigational Site 03

    Melbourne, Australia

  • Investigational Site 04

    Vienna, Austria

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