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.
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