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A study of efficacy and safety of ianalumab in previously treated patients with warm autoimmune haemolytic anaemia
EU CTIS ID: 2024-510635-21-00
What this study is testing
To demonstrate that either dose of ianalumab induces durable hemoglobin (Hb) response compared to placebo in patients with wAIHA. The primary clinical question of interest is: What is the effect of either dose of ianalumab versus placebo (with or without supportive care), in inducing durable hemoglobin response, in wAIHA patients ≥18 years of age who failed at least one line of treatment, regardless of premature discontinuation from study treatment or temporary treatment interruption/delay, and in the absence of rescue or prohibited treatment?
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent form (ICF) must be obtained prior to any screening assessments
- Male or female participants aged 18 years and older on the day of signing the ICF
- Participants with primary or secondary wAIHA (previously documented by positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA), who had an insufficient response to, or relapsed after at least one line of treatment, including patients with corticosteroid resistance, dependence, or intolerance
- Hemoglobin concentration ≥5 g/dL and <10 g/dL and presence of symptoms related to anemia at Screening and Week 1.
- The dose of supportive care must be stable for at least 4 weeks prior randomization.
You likely can't join if
- Patients with wAIHA secondary to hematologic disease involving bone marrow (e.g., chronic lymphocytic leukemia (CLL)) or another disease requiring prohibited medication. Of note, the patients with autoimmune diseases like lupus nephritis (LN), systemic lupus erythematosus (SLE), Primary Sjögren’s Syndrome (pSS) or autoimmune hepatitis (AIH) after wash-out from the treatments are allowed
- Prior use of B-cell depleting therapy: • within 12 weeks prior randomization, or • no hematologic response to the last course of B-cell depleting therapy, irrespective of time of administration
- Active viral, bacterial, or other infections (including active or latent tuberculosis or SARSCoV- 2) requiring systemic treatment at the time of screening or history of recurrent clinically significant infection
- Known history of primary or secondary immunodeficiency, or patients that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)-positive. Refer to Section 5.2 exclusion criterion #7b for exemptions applicable for patients who are HBsAg negative and HBcAb positive.
- Live or live-attenuated vaccination within 4 weeks before randomization
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- China
- Israel
- United States
- Japan
- Thailand
- Malaysia
- Argentina
- United Kingdom
- India
- Singapore
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; China; Israel; United States; Japan; Thailand and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.