Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
Launched by NOVARTIS PHARMACEUTICALS · Dec 14, 2022
Trial Information
Current as of January 13, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called ianalumab to see how well it works in helping adults with a condition called primary immune thrombocytopenia (ITP) maintain a healthy platelet count when taken alongside standard treatments like corticosteroids. Participants will be divided into groups to receive either ianalumab at different doses or a placebo (a dummy treatment with no active medication) to compare results. The main goal is to see if ianalumab can help keep platelet counts at or above 30 G/L, which is important for preventing bleeding.
To participate in the trial, individuals must be at least 18 years old and have been diagnosed with ITP within the last three months. They should have a low platelet count (below 30 G/L) before starting treatment and must have shown some improvement (platelet count of 50 G/L or higher) after receiving corticosteroids or IVIG, which are common initial therapies for ITP. Participants will need to sign consent forms and be willing to follow the study's guidelines. It’s important to note that certain health conditions or previous treatments may prevent someone from joining the trial, so potential participants should discuss their eligibility with their healthcare provider.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Signed informed consent prior to participation in the study.
- • Male or female participants aged 18 years and older on the day of signing informed consent
- • Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG)
- • Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG)
- • Response (platelet count \>=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response.
- Key Exclusion Criteria:
- • Evans syndrome or any other cytopenia (patients with anemia related to bleeding or iron deficiency are eligible)
- • Current life-threatening bleeding
- • Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .
- • Prior use of B-cell depleting therapy (e.g., rituximab).
- • Absolute neutrophil count below 1.0 G/L at randomization
- • Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid
- • 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
Philadelphia, Pennsylvania, United States
Rochester, Minnesota, United States
Cleveland, Ohio, United States
Providence, Rhode Island, United States
Clovis, California, United States
Bethesda, Maryland, United States
Brasschaat, , Belgium
Birmingham, , United Kingdom
Madrid, , Spain
London, , United Kingdom
Rochester, Minnesota, United States
Prahran, Victoria, Australia
Leuven, , Belgium
Lille, , France
Bologna, Bo, Italy
Roma, Rm, Italy
Liverpool, , United Kingdom
Clayton, Victoria, Australia
Essen, , Germany
Vicenza, Vi, Italy
London, , United Kingdom
Hong Kong, , Hong Kong
Bangkok, , Thailand
Oklahoma City, Oklahoma, United States
Dallas, Texas, United States
Salzburg, , Austria
Brugge, , Belgium
Jena, , Germany
Sevilla, Andalucia, Spain
Dresden, , Germany
Frankfurt, , Germany
Leeds, , United Kingdom
Nottingham, , United Kingdom
Guangzhou, Guangdong, China
Singapore, , Singapore
Madrid, , Spain
Chiang Mai, , Thailand
Tianjin, , China
Buenos Aires, , Argentina
Lille Cedex, , France
Paris, , France
Budapest, , Hungary
Izmir, , Turkey
Caen, Cedex, France
Firenze, Fi, Italy
Roma, Rm, Italy
Selangor, , Malaysia
Monterrey, Nuevo Leon, Mexico
Singapore, , Singapore
Salamanca, Castilla Y Leon, Spain
Istanbul, Tur, Turkey
Roeselare, , Belgium
Varna, , Bulgaria
Praha 10, , Czechia
Le Mans, , France
Murcia, , Spain
Caba, Buenos Aires, Argentina
Cordoba, , Argentina
Beijing, Beijing, China
Changsha, Hunan, China
Chengdu, Sichuan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Budapest, , Hungary
Debrecen, , Hungary
Truro, Cornwall, United Kingdom
Southampton, , United Kingdom
Barcelona, Catalunya, Spain
Rennes, , France
Innsbruck, Tyrol, Austria
Wien, , Austria
Tianjin, Tianjin, China
Beijing, , China
Canberra, Australian Capital Territory, Australia
Wooloongabba, Queensland, Australia
Wuhan, Hubei, China
Jinan, , China
Aydin, , Turkey
Nyack, New York, United States
Osaka City, Osaka, Japan
Greifswald, , Germany
Lake Success, New York, United States
Plovdiv, , Bulgaria
Kuching, Sarawak, Malaysia
Brno Bohunice, Czech Republic, Czechia
New Territories, , Hong Kong
Okayama City, Okayama, Japan
Mumbai, Maharashtra, India
Edirne, , Turkey
Chambéry Cedex, , France
Giessen, , Germany
Bucharest, District 2, Romania
Hannover, , Germany
Izmir, , Turkey
Caen, , France
Praha, , Czechia
Samsun, , Turkey
Nanchang, Jiangxi, China
Fort Wayne, Indiana, United States
Melbourne, Victoria, Australia
Kuala Lumpur, , Malaysia
Ahmedabad, Gujarat, India
Nagakute City, Aichi, Japan
Chongqing, Chongqing, China
Brno Bohunice, , Czechia
Ogden, Utah, United States
Sofia, , Bulgaria
Saint Louis Park, Minnesota, United States
Matsumoto City, Nagano, Japan
Hanoi, , Vietnam
Taiyuan, Shanxi, China
Le Mans, Cedex 09, France
Bucharest, , Romania
Glasgow, , United Kingdom
Mcallen, Texas, United States
Trieste, Ts, Italy
Kuala Lumpur, Mys, Malaysia
Shibukawa City, Gunma, Japan
Farmington Hills, Michigan, United States
Billings, Montana, United States
Aurora, Colorado, United States
Johor Bahru, , Malaysia
Gralum, , Norway
Bengbu, , China
Ciudad De Mexico, Mexico Cp, Mexico
Gifu Shi, Gifu, Japan
Ciudad Autonoma De Bs As, Buenos Aires, Argentina
Istanbul, , Turkey
Zhengzhou, Henan, China
Xian, Shaanxi, China
Iruma Gun, Saitama, Japan
Shenzhen, Guangdong, China
Kolkata, West Bengal, India
Morelia, Michoacan, Mexico
Shijiazhuang, , China
Chongqing City, Chongqing, China
Chiba, , Japan
Florham Park, New Jersey, United States
Tampa, Florida, United States
Ostrava, Poruba, Czechia
Luoyang, Henan, China
Margate, Florida, United States
Tucuman, San Miguel De Tucuman, Argentina
Fort Wayne, Indiana, United States
Bucuresti, , Romania
Sapporo, Hokkaido, Japan
Dalian, , China
Changzhou, Jiangsu, China
Fukuoka, , Japan
Buenos Aires, , Argentina
Mullica Hill, New Jersey, United States
Billings, Montana, United States
Lake Success, New York, United States
Ho Chi Minh, , Vietnam
Cleveland, Ohio, United States
San Antonio, Texas, United States
Yuma, Arizona, United States
Oklahoma City, Oklahoma, United States
Penang, , Malaysia
Fountain Valley, California, United States
Chicago, Illinois, United States
Saint Louis Park, Minnesota, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Dayton, Ohio, United States
Fountain Valley, California, United States
Dallas, Texas, United States
Chambery Cedex, , France
San Antonio, Texas, United States
Rochester, Minnesota, United States
Dayton, Ohio, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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