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A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

NCT05653219

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Primary Immune Thrombocytopenia

Interventions: Ianalumab, Eltrombopag, Placebo

Countries: United States, Argentina, Austria, Belgium, China, Czechia, France, Germany

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 overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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. Nursing (breast feeding) or pregnant women

Other protocol-defined inclusion/exclusion criteria may apply.
Locations (74)
  • Yuma, Arizona, United States
  • Aurora, Colorado, United States
  • Evanston, Illinois, United States
  • Boston, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Farmington Hills, Michigan, United States
  • Billings, Montana, United States
  • Nyack, New York, United States
  • The Bronx, New York, United States
  • CABA, Argentina
  • Vienna, Austria
  • Yvoir, Namur, Belgium
  • Roeselare, West-Vlaanderen, Belgium
  • Guangzhou, Guangdong, China
  • Wuhan, Hubei, China
  • Binzhou, Shandong, China
  • Hangzhou, Zhejiang, China
  • Beijing, China
  • Jinan, China
  • Tianjin, China
  • Brno, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Blois, France
  • Le Mans, France
  • Cologne, North Rhine-Westphalia, Germany
  • Dresden, Saxony, Germany
  • Jena, Thuringia, Germany
  • Dresden, Germany
  • Debrecen, Hajdu Bihar Megye, Hungary
  • + 44 more on CT.gov