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
1. Male or female patients aged 18 years and older on the day of signing the informed
consent.
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
Key Exclusion criteria
1. 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.
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. Female patients who are pregnant or nursing
Other protocol-defined inclusion/exclusion criteria may apply.
Study Location
Novartis Investigative Site
Recruiting
Buenos Aires,C1425aum,Argentina
Novartis Investigative Site
Recruiting
Caba,Buenos Aires,C1181ach,Argentina
Novartis Investigative Site
Recruiting
Clayton,Victoria,3168,Australia
Novartis Investigative Site
Recruiting
Parkville,Victoria,3050,Australia
Novartis Investigative Site
Recruiting
Wels,A 4600,Austria
Novartis Investigative Site
Recruiting
Linz,4010,Austria
Novartis Investigative Site
Recruiting
Vienna,A 1090,Austria
Novartis Investigative Site
Recruiting
Roeselare,8800,Belgium
Novartis Investigative Site
Recruiting
Leuven,3000,Belgium
Novartis Investigative Site
Recruiting
Yvoir,5530,Belgium
Novartis Investigative Site
Recruiting
Ji Nan,250012,China
Novartis Investigative Site
Recruiting
Beijing,100044,China
Novartis Investigative Site
Recruiting
Wuhan,Hubei,430022,China
Novartis Investigative Site
Recruiting
Suzhou,Jiangsu,215006,China
Novartis Investigative Site
Recruiting
Beijing,100730,China
Novartis Investigative Site
Recruiting
Tianjin,300020,China
Novartis Investigative Site
Recruiting
Binzhou,Shandong,256603,China
Novartis Investigative Site
Recruiting
Tianjin,300052,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510515,China
Novartis Investigative Site
Recruiting
Hangzhou,Zhejiang,310003,China
Novartis Investigative Site
Recruiting
Praha,12808,Czechia
Novartis Investigative Site
Recruiting
Brno Bohunice,Czech Republic,625 00,Czechia
Novartis Investigative Site
Recruiting
Praha 10,100 34,Czechia
Novartis Investigative Site
Recruiting
Le Mans,Cedex 09,72037,France
Novartis Investigative Site
Recruiting
Blois Cedex,41000,France
Novartis Investigative Site
Recruiting
Vandoeuvre Les Nancy,54511,France
Novartis Investigative Site
Recruiting
Dresden,01307,Germany
Novartis Investigative Site
Recruiting
Giessen,35392,Germany
UMASS Memorial Medical Center
Recruiting
Worcester,Massachusetts,01665,United States
Daniel Winokur
Community Cancer Institute
Recruiting
Clovis,California,93611,United States
Mohammed Bukari
NorthShore University Health System
Recruiting
Evanston,Illinois,60201,United States
Amy Wang
STAT Research Inc Premier Clin Res LLC STAT Res
Recruiting
Dayton,Ohio,45402,United States
Charles Bane
University of Pennsylvania
Recruiting
Philadelphia,Pennsylvania,19104,United States
Adam Cuker
INTEGRIS Cancer Institute of Oklahoma Integris South West Med Center
Recruiting
Oklahoma City,Oklahoma,73142,United States
Basgar Alasad
Kellie Larsen-Dyer
Community Cancer Trials of Utah
Recruiting
Ogden,Utah,84405,United States
Carl Gray
Washington U Sch Of Med Ctr For CS Center For Advanced Medicine
Recruiting
Saint Louis,Missouri,63110,United States
Morey A. Blinder
Center of Clnl Rsch and Innovation
Recruiting
Houston,Texas,77008,United States
Adriana Mccray
John Knecht
Uni of Chi Medi Ctr Hema and Onco Main Centre
Recruiting
Chicago,Illinois,60637,United States
Michael Drazer
Yuma Regional Medical Center
Recruiting
Yuma,Arizona,85349,United States
Abhinav Chandra
Amy Olmeda
Montefiore Medical Center .
Recruiting
Bronx,New York,10461,United States
Irina Murakhovskaya
Compassionate Care Res Group Inc
Recruiting
Fountain Valley,California,92708,United States
Eric Lee
Clinical Research Alliance Research
Recruiting
Lake Success,New York,11042,United States
James D Olimpio
Parkview Research Center .
Recruiting
Fort Wayne,Indiana,46845,United States
Jeffrey Letzer
University of Colorado Anschutz
Recruiting
Aurora,Colorado,80045,United States
George Gemlyn
St Vincent Frontier Cancer Center .
Recruiting
Billings,Montana,59102,United States
Patrick Cobb
Napa Research
Recruiting
Margate,Florida,33063,United States
Emilio Araujo-Mino
Hematology Oncology Association of Rockland
Recruiting
Nyack,New York,10960,United States
Sung Ho Lee
Worldwide Contacts
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