Study Description
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.
This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count <30 G/L) who failed previous first-line treatment with corticosteroids.
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.
Interventions
Eltrombopag
Ianalumab
Placebo
Eligibility Criteria
Key Inclusion criteria
Male or female patients aged 18 years and older on the day of signing the informed consent.
A signed informed consent must be obtained prior to participation in the study.
A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
Patient with platelet count <30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag
Key Exclusion criteria
ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
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).
Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
Patients with current or history of life-threatening bleeding
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
Patients with known active or uncontrolled infection requiring systemic treatment during screening period
Patients with hepatic impairment
Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily)
Female patients who are pregnant or nursing
Other protocol-defined inclusion/exclusion criteria may apply.
Study Location
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Caba,Buenos Aires,C1181ACH,Argentina
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Buenos Aires,C1425AUM,Argentina
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Clayton,Victoria,3168,Australia
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Parkville,Victoria,3050,Australia
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Linz,4010,Austria
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Vienna,A 1090,Austria
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Wels,A 4600,Austria
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Yvoir,5530,Belgium
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Leuven,3000,Belgium
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Roeselare,8800,Belgium
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Wuhan,Hubei,430022,China
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Hangzhou,Zhejiang,310003,China
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Suzhou,Jiangsu,215006,China
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Beijing,100044,China
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Tianjin,300020,China
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Beijing,100730,China
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Tianjin,300052,China
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Binzhou,Shandong,256603,China
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Ji Nan,250012,China
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Guangzhou,Guangdong,510515,China
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Brno Bohunice,Czech Republic,625 00,Czech Republic
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Praha 10,100 34,Czech Republic
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Praha,12808,Czech Republic
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Dresden,01307,Germany
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Hannover,30161,Germany
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Koeln,50937,Germany
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Giessen,35392,Germany
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Jena,07740,Germany
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Greifswald,17475,Germany
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Budapest,1085,Hungary
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Debrecen,4032,Hungary
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Chandigarh,160 012,India
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Kolkata,West Bengal,700014,India
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Rishikesh,Uttarakhand,249203,India
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Trieste,TS,34129,Italy
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Roma,RM,00133,Italy
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Roma,RM,00168,Italy
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Vicenza,VI,36100,Italy
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Bologna,BO,40138,Italy
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Torino,TO,10126,Italy
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Suita,Osaka,565 0871,Japan
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Narita,Chiba,286-8523,Japan
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Kumamoto-city,Kumamoto,860-0008,Japan
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Omura,Nagasaki,856-8562,Japan
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Kofu-city,Yamanashi,400-8506,Japan
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Chuo ku,Tokyo,104-8560,Japan
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Osaka-city,Osaka,540-0006,Japan
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Aomori,030 8553,Japan
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Bunkyo-ku,Tokyo,113-8603,Japan
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Nagoya,Aichi,453-8511,Japan
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Seoul,06351,Korea, Republic of
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Jeollanam,519763,Korea, Republic of
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Penang,10050,Malaysia
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Kuching,Sarawak,93586,Malaysia
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Pulau Pinang,10990,Malaysia
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Kota Kinabalu,Sabah,88586,Malaysia
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Subang Jaya,Selangor,47500,Malaysia
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Selangor,68000,Malaysia
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Kuala Lumpur,MYS,56000,Malaysia
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Johor Bahru,80100,Malaysia
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Utrecht,3584 CX,Netherlands
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Gralum,1714,Norway
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Makati City,1229,Philippines
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Quezon,1102,Philippines
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Sibiu,550245,Romania
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Bucharest,District 2,022328,Romania
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Bucharest,030 171,Romania
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Timisoara,300079,Romania
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Craiova,200136,Romania
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Singapore,119228,Singapore
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Singapore,169608,Singapore
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Singapore,S308433,Singapore
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Barcelona,Catalunya,08003,Spain
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Madrid,28041,Spain
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Salamanca,Castilla Y Leon,37007,Spain
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Madrid,28046,Spain
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Santiago De Compostela,Galicia,15706,Spain
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Murcia,30008,Spain
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Kaohsiung,83301,Taiwan
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Taoyuan,33305,Taiwan
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Bangkok,10700,Thailand
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Chiang Mai,50200,Thailand
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Bangkok,10330,Thailand
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Edirne,22030,Turkey
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Izmir,35040,Turkey
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Ankara,06100,Turkey
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Samsun,55139,Turkey
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Aydin,09100,Turkey
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London,SW17 0QT,United Kingdom
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London,W12 0HS,United Kingdom
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Truro,Cornwall,TR1 3LJ,United Kingdom
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Nottingham,NG5 1PB,United Kingdom
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London,E1 1BB,United Kingdom
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Oxford,OX3 7LE,United Kingdom
Montefiore Medical Center .
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Bronx,Noelle Townsend (718-920-2680) email: [email protected] -- Irina Murakhovskaya,10461 - New York,United States
Clinical Research Alliance Research
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Lake Success,William Krenn (+1 516 488 2918#183) email: [email protected] -- James D Olimpio,11042 - New York,United States
Napa Research
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Margate,Emilio Araujo-Mino,33063 - Florida,United States
Community Cancer Institute
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Clovis,(559-387-1850) -- Mohammed Bukari,93611 - California,United States
St Vincent Frontier Cancer Center .
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Billings,Amanda Klein (406-238-6290) email: [email protected] -- Patrick Cobb,59102 - Montana,United States
NorthShore University Health System
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Evanston,Michele Britto (847-570-2109) email: [email protected] -- Amy Wang,60201 - Illinois,United States
Community Cancer Trials of Utah
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Ogden,Sibian Torres (801-689-3909) email: [email protected] -- Carl Gray,84405 - Utah,United States
STAT Research Inc Premier Clin Res LLC STAT Res
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Dayton,Charles Bane,45402 - Ohio,United States
Compassionate Care Res Group Inc
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Fountain Valley,(714-210-2300) -- Eric Lee,92708 - California,United States
Texas Oncology Drug Ship - 5
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Dallas,(214-370-1614) -- Racha Halawi,75251 - Texas,United States
Hematology Oncology Association of Rockland
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Nyack,Marion VanWoudenberg (845-362-1750) email: [email protected] -- Sung Ho Lee,10960 - New York,United States
Uni of Chi Medi Ctr Hema and Onco Main Centre
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Chicago,Sara Moellering (773-834-0783) email: [email protected] -- Michael Drazer,60637 - Illinois,United States
INTEGRIS Cancer Institute of Oklahoma Integris South West Med Center
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Oklahoma City,Kellie Larsen-Dyer email: [email protected] -- Basgar Alasad,73142 - Oklahoma,United States
Center of Clnl Rsch and Innovation
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Houston,Adriana McCray email: [email protected] -- John Knecht,77008 - Texas,United States
Yuma Regional Medical Center
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Yuma,Amy Olmeda email: [email protected] -- Abhinav Chandra,85349 - Arizona,United States
Worldwide Contacts
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