A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
NCT ID: NCT05653219
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
152 participants
INTERVENTIONAL
2023-02-02
2028-04-08
Brief Summary
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Detailed Description
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After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment arm 1
Participants will receive eltrombopag and ianalumab lower dose
Ianalumab
Concentrate for solution for infusion for intravenous use
Eltrombopag
Film-coated tablet for oral use
Treatment arm 2
Participants will receive eltrombopag and ianalumab higher dose
Ianalumab
Concentrate for solution for infusion for intravenous use
Eltrombopag
Film-coated tablet for oral use
Treatment arm 3
Participants will receive eltrombopag and placebo
Eltrombopag
Film-coated tablet for oral use
Placebo
Concentrate for solution for infusion for intravenous use.
Interventions
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Ianalumab
Concentrate for solution for infusion for intravenous use
Eltrombopag
Film-coated tablet for oral use
Placebo
Concentrate for solution for infusion for intravenous use.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A signed informed consent must be obtained prior to participation in the study.
3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
4. Patient with platelet count \<30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag
Exclusion Criteria
2. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia, (patients with low grade anemia related to bleeding or iron deficiency are eligible).
3. Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
4. Patients with current or history of life-threatening bleeding
5. Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)-positive. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given
6. Patients with known active or uncontrolled infection requiring systemic treatment during screening period
7. Patients with hepatic impairment
8. Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily)
9. Nursing (breast feeding) or pregnant women
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Chiang Mai, , Thailand
Yuma Regional Medical Center
Yuma, Arizona, United States
University of Colorado Anschutz
Aurora, Colorado, United States
NorthShore University Health System
Evanston, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, United States
St Vincent Frontier Cancer Center
Billings, Montana, United States
Hematology Oncology Association of Rockland
Nyack, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Novartis Investigative Site
CABA, , Argentina
Novartis Investigative Site
Vienna, , Austria
Novartis Investigative Site
Yvoir, Namur, Belgium
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium
Novartis Investigative Site
Guangzhou, Guangdong, China
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Wuhan, Hubei, China
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Binzhou, Shandong, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Jinan, , China
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Tianjin, , China
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Blois, , France
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Le Mans, , France
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Cologne, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Jena, Thuringia, Germany
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Dresden, , Germany
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Debrecen, Hajdu Bihar Megye, Hungary
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Budapest, , Hungary
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Rishikesh, Uttarakhand, India
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Kolkata, West Bengal, India
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Bologna, BO, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Trieste, TS, Italy
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Nagoya, Aichi-ken, Japan
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Osaka, Osaka, Japan
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Suita, Osaka, Japan
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Kofu, Yamanashi, Japan
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Kumamoto, , Japan
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George Town, Pulau Pinang, Malaysia
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Kota Kinabalu, Sabah, Malaysia
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Subang Jaya, Selangor, Malaysia
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George Town, , Malaysia
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Johor Bahru, , Malaysia
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Kuala Selangor, , Malaysia
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Saltillo, Coahuila, Mexico
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Morelia, Michoacán, Mexico
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Monterrey, Nuevo León, Mexico
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Leiden, South Holland, Netherlands
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Utrecht, , Netherlands
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Makati City, , Philippines
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Quezon, , Philippines
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Craiova, Dolj, Romania
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Timișoara, , Romania
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Singapore, , Singapore
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Singapore, , Singapore
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Jeollanam, , South Korea
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Seoul, , South Korea
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Santiago Compostela, A Coruna, Spain
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Salamanca, , Spain
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Samsun, Atakum, Turkey (Türkiye)
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Ankara, Bilkent Cankaya, Turkey (Türkiye)
Novartis Investigative Site
Aydin, Efeler, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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London, , United Kingdom
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London, , United Kingdom
Novartis Investigative Site
Oxford, , United Kingdom
Countries
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References
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Cuker A, Stauch T, Cooper N, Al-Samkari H, Michel M, Ghanima W, Urban P, Fronczek J, Foster M, Weill M, Zhang L, Hou M, Zander T, Sharif A, Sun J, Nath UK, Schutgens R, Rossi E, Deleu L, Cervinek L, Yoon JH, Chang H, Ruchutrakool T, Iino M, Goto T, Zaja F; VAYHIT2 Investigators. Ianalumab plus Eltrombopag in Immune Thrombocytopenia. N Engl J Med. 2025 Dec 9. doi: 10.1056/NEJMoa2515168. Online ahead of print.
Other Identifiers
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2024-512890-28-00
Identifier Type: OTHER
Identifier Source: secondary_id
CVAY736Q12301
Identifier Type: -
Identifier Source: org_study_id
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