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 January 14, 2025
Recruiting
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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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