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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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. Nursing (breast feeding) or pregnant women
Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
Time from randomization until treatment failure — Randomization to until end of study (up to 39 months after randomization of last participant) Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure:
* platelet count below 30 G/L
* start of a new ITP treatment
* need for a rescue treatment
* ineligibility to taper or inability to discontinue eltrombopag
* death
Trial sites (74)
Facility
City
Region
Status
Yuma Regional Medical Center
Yuma
Arizona
University of Colorado Anschutz
Aurora
Colorado
NorthShore University Health System
Evanston
Illinois
Boston Medical Center
Boston
Massachusetts
UMASS Memorial Medical Center
Worcester
Massachusetts
Michigan Center of Medical Research
Farmington Hills
Michigan
St Vincent Frontier Cancer Center
Billings
Montana
Hematology Oncology Association of Rockland
Nyack
New York
Montefiore Medical Center
The Bronx
New York
Novartis Investigative Site
CABA
Argentina
Novartis Investigative Site
Vienna
Austria
Novartis Investigative Site
Yvoir
Namur
Novartis Investigative Site
Roeselare
West-Vlaanderen
Novartis Investigative Site
Guangzhou
Guangdong
Novartis Investigative Site
Wuhan
Hubei
Novartis Investigative Site
Binzhou
Shandong
Novartis Investigative Site
Hangzhou
Zhejiang
Novartis Investigative Site
Beijing
China
Novartis Investigative Site
Jinan
China
Novartis Investigative Site
Tianjin
China
Novartis Investigative Site
Brno
Czechia
Novartis Investigative Site
Prague
Czechia
Novartis Investigative Site
Prague
Czechia
Novartis Investigative Site
Blois
France
Novartis Investigative Site
Le Mans
France
Novartis Investigative Site
Cologne
North Rhine-Westphalia
Novartis Investigative Site
Dresden
Saxony
Novartis Investigative Site
Jena
Thuringia
Novartis Investigative Site
Dresden
Germany
Novartis Investigative Site
Debrecen
Hajdu Bihar Megye
Novartis Investigative Site
Budapest
Hungary
Novartis Investigative Site
Rishikesh
Uttarakhand
Novartis Investigative Site
Kolkata
West Bengal
Novartis Investigative Site
Bologna
BO
Novartis Investigative Site
Roma
RM
Novartis Investigative Site
Roma
RM
Novartis Investigative Site
Trieste
TS
Novartis Investigative Site
Nagoya
Aichi-ken
Novartis Investigative Site
Osaka
Osaka
Novartis Investigative Site
Suita
Osaka
+ 34 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.