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Search / Trial NCT05648968

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

Launched by NOVARTIS PHARMACEUTICALS · Dec 5, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Warm Autoimmune Hemolytic Anemia W Aiha Ianalumab Vay736 B Cell Depletion B Cell Activating Factor Receptor (Baff R) Blockade

ClinConnect Summary

This clinical trial is studying a new treatment called ianalumab for patients with a condition known as warm autoimmune hemolytic anemia (wAIHA). This condition causes the body to destroy its own red blood cells, leading to anemia, which is a shortage of red blood cells that can make you feel tired and weak. The trial aims to see if ianalumab is effective and safe compared to a placebo (a harmless pill with no active treatment) for patients who have already tried at least one other treatment that didn't work.

To be eligible for this study, participants need to be at least 18 years old and have been diagnosed with wAIHA, showing specific test results. They should also have low levels of hemoglobin, which is a protein in red blood cells, and experience symptoms related to anemia. Participants will be closely monitored throughout the study, and everyone will receive either ianalumab or the placebo. It's important to note that people with certain other medical conditions, recent infections, or specific treatments may not qualify for this trial. If you or a loved one is considering participation, it's a great opportunity to potentially access a new treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Novartis Pharmaceuticals

Study Director

Novartis Pharmaceuticals

About Novartis Pharmaceuticals

Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.

Locations

Bronx, New York, United States

Canton, Ohio, United States

Seattle, Washington, United States

Birmingham, , United Kingdom

Prahran, Victoria, Australia

Lille, , France

Vandoeuvre Les Nancy, , France

Essen, , Germany

Milano, Mi, Italy

Barcelona, Catalunya, Spain

Taoyuan, , Taiwan

London, , United Kingdom

Evanston, Illinois, United States

Creteil, , France

Shinjuku Ku, Tokyo, Japan

Dresden, , Germany

Frankfurt, , Germany

Leeds, , United Kingdom

London, , United Kingdom

Guangzhou, Guangdong, China

Petach Tikva, , Israel

Singapore, , Singapore

Bangkok, , Thailand

Chiang Mai, , Thailand

Tianjin, , China

Caen, Cedex, France

Nice Cedex, , France

Toulouse, , France

Selangor, , Malaysia

Singapore, , Singapore

London, , United Kingdom

Le Mans, , France

New Delhi, , India

Kfar Saba, , Israel

Murcia, , Spain

Suzhou, Jiangsu, China

Kunming, Yunnan, China

Hangzhou, Zhejiang, China

Tianjin, , China

Debrecen, , Hungary

Lille Cedex, , France

Nantes Cedex 1, , France

Bari, Ba, Italy

Canberra, Australian Capital Territory, Australia

Wuhan, Hubei, China

Frankfurt, , Germany

Madurai, Tamil Nadu, India

Hyderabad, Telangana, India

Lucknow, Uttar Pradesh, India

Milano, Mi, Italy

Novara, , Italy

Suzhou, Jiangsu, China

Greifswald, , Germany

Kuching, Sarawak, Malaysia

Nice, , France

Itabashi Ku, Tokyo, Japan

Fukuoka City, Fukuoka, Japan

Giessen, , Germany

Avellino, Av, Italy

Hannover, , Germany

Afula, , Israel

Caen, , France

Fort Wayne, Indiana, United States

Kobe City, Hyogo, Japan

Melbourne, Victoria, Australia

Pulau Pinang, , Malaysia

Kuala Lumpur, , Malaysia

London, , United Kingdom

Isehara, Kanagawa, Japan

Aomori, , Japan

Yamagata, , Japan

Narita, Chiba, Japan

Le Mans, Cedex 09, France

Gifu City, Gifu, Japan

Petach Tikva, , Israel

Kuala Lumpur, Mys, Malaysia

Farmington Hills, Michigan, United States

Aurora, Colorado, United States

Johor Bahru, , Malaysia

Matsuyama City, Ehime, Japan

Ciudad Autonoma De Bs As, Buenos Aires, Argentina

Bassano Del Grappa, Vi, Italy

Kobe, Hyogo, Japan

Zerifin, Hamerkaz, Israel

Florham Park, New Jersey, United States

Dresden, Saxonia, Germany

Caba, Buenos Aires, Argentina

Suita, Osaka, Japan

Margate, Florida, United States

Fort Wayne, Indiana, United States

Bucuresti, , Romania

Dalian, , China

Buenos Aires, , Argentina

Mullica Hill, New Jersey, United States

Blois Cedex, , France

Bronx, New York, United States

Penang, , Malaysia

Minneapolis, Minnesota, United States

Dayton, Ohio, United States

Dallas, Texas, United States

Shinjuku Ku, Tokyo, Japan

Madurai, Tamilnadu, India

Zerifin, , Israel

Bassano Del Grappa, Vicenza, Italy

Dayton, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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