Trials
Search / Trial NCT05653349

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

Primary Immune Thrombocytopenia (Itp) Ianalumab Vay736 B Cell Depletion B Cell Activating Factor Receptor (Baff R) Blockade

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.

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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