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New hope for rare blood disorder: drug trial targets anemia

NCT ID NCT05648968

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This phase 3 trial tests a drug called ianalumab against a placebo in 90 adults with warm autoimmune hemolytic anemia (wAIHA) who have already tried at least one treatment without success. The goal is to see if ianalumab can raise hemoglobin levels and keep them stable for at least eight weeks. Participants receive IV infusions of either the drug or a placebo, and researchers track their response over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ianalumab (a biologic drug given by IV infusion)
What this could lead to
If it works, this could offer a new treatment option for people with warm autoimmune hemolytic anemia who haven't responded to standard therapies.
What could go wrong
This is a phase 3 trial, but it's still experimental. The drug may not work better than placebo, and there could be side effects like infusion reactions or infections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

90 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

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 to 100 years

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.

Key Inclusion Criteria: * 18 years and older at time of signing consent * Patients with primary or secondary wAIHA documented by positive direct antiglobulin test 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 steroid resistance, dependence or intolerance * Hemoglobin concentration at screening and at Week 1 \>=5 g/dL and \<10 g/dL, associated with presence of symptoms related to anemia * The dose of supportive care must be stable for at least 4 weeks prior to randomization into the study Key Exclusion Criteria: * wAIHA secondary to hematologic disease involving bone marrow (e.g., CLL) or another immunologic disease requiring prohibited medication as per protocol. Patients with autoimmune diseases after wash-out from the treatments are allowed. * Presence of other forms of AIHA (cold or intermediate forms), Evans Syndrome or other cytopenias * Prior use of B-cell depleting therapy (e.g., rituximab) within 12 weeks prior to randomization, or without hematological response to the last course of B-cell depleting therapy * Neutrophils: \<1000/mm3 * Serum creatinine \>1.5 × upper limit of normal (ULN) * Immunoglobulin G (IgG) \<5g/L * Active viral, bacterial or other infections (including tuberculosis and SARS-CoV-2) requiring systemic treatment at time of screening, or history of recurrent clinically significant infection * Positivity for hepatitis C virus, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb). HBcAb positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given. * Known history of primary or secondary immunodeficiency, or a positive human immune deficiency virus (HIV) test result * Live or live-attenuated vaccination within 4 weeks before randomization * History of splenectomy Other protocol-defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia, warm type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Warm autoimmune hemolytic anemia (waiha)

Contacts and locations

Locations

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Michigan Center of Medical Research

    Farmington Hills, Michigan, 48334, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414DRK, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1039AAC, Argentina

  • Novartis Investigative Site

    Caba, C1015ABO, Argentina

  • Novartis Investigative Site

    Garran, Australian Capital Territory, 2605, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    Dalian, 116000, China

  • Novartis Investigative Site

    Tianjin, 300020, China

  • Novartis Investigative Site

    Tianjin, 300052, China

  • Novartis Investigative Site

    Créteil, 94010, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Nice, 06202, France

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Giessen, 35392, Germany

  • Novartis Investigative Site

    Hanover, 30161, Germany

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Novartis Investigative Site

    Madurai, Tamil Nadu, 625107, India

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082, India

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226014, India

  • Novartis Investigative Site

    Kfar Saba, 4428164, Israel

  • Novartis Investigative Site

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    Milan, MI, 20100, Italy

  • Novartis Investigative Site

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    Bassano del Grappa, VI, 36061, Italy

  • Novartis Investigative Site

    Novara, 28100, Italy

  • Novartis Investigative Site

    Narita, Chiba, 2868523, Japan

  • Novartis Investigative Site

    Matsuyama, Ehime, 7900024, Japan

  • Novartis Investigative Site

    Gifu, Gifu, 5011194, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    Isehara, Kanagawa, 2591193, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 1738610, Japan

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 1600023, Japan

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Johor Bahru, 80100, Malaysia

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 308433, Singapore

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Murcia, 30008, Spain

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Novartis Investigative Site

    Leeds, LS1 3EX, United Kingdom

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

  • University of Minnesota Med Center

    Minneapolis, Minnesota, 55455, United States

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