Study of ianalumab versus placebo in adults with warm autoimmune hemolytic anemia who failed previous treatment

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What is this study about?

This clinical trial studies warm autoimmune hemolytic anemia (wAIHA), a condition where the body’s immune system destroys its own red blood cells. The study tests a new medication called ianalumab (also known as VAY736) against placebo in people whose previous treatments were not successful. The medication is given through intravenous infusion.

The main purpose of the study is to determine if ianalumab can help maintain healthy blood levels in people with wAIHA. During the study, participants will be randomly assigned to receive either ianalumab or placebo. The study will measure whether the treatment can increase and maintain hemoglobin levels, which is an important component of red blood cells that carries oxygen throughout the body.

The treatment period lasts for 32 weeks, during which participants will receive regular infusions. Throughout the study, doctors will monitor blood levels, check for side effects, and track how participants feel. Some participants may also receive standard supportive care medications such as corticosteroids, antihistamines, or other treatments commonly used for this condition.

1 Initial treatment phase

Your participation begins with receiving either ianalumab or a placebo through intravenous infusion

The treatment aims to increase your hemoglobin levels to 10 g/dL or higher, with at least a 2 g/dL increase from your starting level

Your current hemoglobin level must be between 5 g/dL and 10 g/dL at the start of the study

2 Treatment monitoring period (Weeks 1-8)

Regular monitoring of your hemoglobin levels will occur

Your blood will be tested to measure B-cell counts and immunoglobulin levels

Medical staff will monitor your response to the treatment

3 Response evaluation period (Weeks 9-25)

The main evaluation period begins at week 9

Your hemoglobin levels will be regularly checked to determine if you have achieved a lasting response

A successful response means maintaining increased hemoglobin levels for at least 8 weeks

4 Extended monitoring

Blood tests will continue to check your response to treatment

Medical staff will monitor any side effects

Your overall health and well-being will be assessed through questionnaires

The study continues until February 2029

Who Can Join the Study?

Must sign a written informed consent form before any screening tests can begin
Must be at least 18 years of age or older when signing the consent form
Must have warm autoimmune hemolytic anemia (wAIHA) that has been previously confirmed by a positive direct antiglobulin test (a blood test that checks for antibodies attached to red blood cells)
Must have had insufficient response to, or relapsed after, at least one previous treatment, including:
- resistance to corticosteroids (medications that reduce inflammation)
- dependence on corticosteroids
- intolerance to corticosteroids
Must have a hemoglobin level (protein that carries oxygen in blood) between 5 and 10 g/dL and show symptoms of anemia during screening and first week
Must be on stable supportive care treatment for at least 4 weeks before being randomly assigned to a treatment group

Who Cannot Join the Study?

History of severe allergic reactions or anaphylaxis to biological treatments
Active or chronic hepatitis B or hepatitis C infection
Current diagnosis of malignancy (cancer) or cancer treatment within the past 5 years
Severe or uncontrolled cardiovascular disease (heart conditions)
Significant kidney or liver problems
Active serious infections requiring treatment
Pregnant or breastfeeding women
Use of prohibited medications within specified timeframe before study start
History of other autoimmune conditions that could interfere with the study
Mental conditions that could affect ability to comply with study procedures
Major surgery within 3 months before starting the study
Participation in another clinical trial within 30 days before this study
Blood transfusion dependence (requiring regular blood transfusions)
Presence of other blood disorders that could affect study results
Unstable medical conditions that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Gemeinschaftspraxis Haematologie Onkologie	Dresden	Germany
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
ASST Fatebenefratelli Sacco	Milan	Italy
Hospital General Universitario Morales Meseguer	Murcia	Spain
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Neolife Medical Center	Bucharest	Romania
Regione Del Veneto Azienda ULSS N 7 Pedemontana	Bassano Del Grappa	Italy
University Of Debrecen	Debrecen	Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Le Mans	Le Mans	France
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Udnnjdkloffekqxgpzmxa Ewhef Ayq	Essen	Germany
Shfjvblqkmrqou ap Rufxjnipoc	Hanover	Germany
Hnoczbuf Vnsv dvftgxac	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	09.05.2023
Germany	Not recruiting	09.05.2023
Hungary	Not recruiting	09.05.2023
Italy	Not recruiting	09.05.2023
Romania	Not recruiting	09.05.2023
Spain	Not recruiting	09.05.2023

Trial locations

Investigated drugs:

Ianalumab (VAY736) is a medication being studied for the treatment of warm autoimmune hemolytic anemia (wAIHA). It is designed to help patients whose blood condition has not improved after at least one previous treatment. This medication works by targeting the immune system to reduce the destruction of red blood cells that occurs in this disease. The medication is being tested to see if it can help maintain healthy levels of hemoglobin in the blood.

Placebo is an inactive substance that contains no medication. It is used as a comparison to determine how effective the actual medication (ianalumab) is in treating the condition.

Warm Autoimmune Hemolytic Anemia (wAIHA) – A blood disorder where the immune system mistakenly attacks and destroys red blood cells at body temperature. In this condition, antibodies attach to red blood cells, causing them to break down faster than the body can replace them. The destruction of red blood cells leads to a decrease in hemoglobin levels and can cause anemia. The condition typically develops gradually and can occur at any age. Common signs include fatigue, weakness, pale skin, and shortness of breath due to reduced oxygen-carrying capacity of the blood.

Trial ID:

2024-510635-21-00

Protocol code:

CVAY736O12301

NCT ID:

NCT05648968

Trial Phase:

Therapeutic confirmatory (Phase III)

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