Last Update: Aug 20, 2024
A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVAY736Q12301
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Primary Immune Thrombocytopenia
Phase3
Recruiting
150
Feb 02, 2023
May 19, 2028
All
18 Years - (Adult, Older Adult)

Interventions

Drug

Eltrombopag

Film-coated tablet for oral use
Biological

Ianalumab

Concentrate for solution for infusion for intravenous use
Drug

Placebo

Concentrate for solution for infusion for intravenous use.

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

Vienna,A 1090,Austria

Novartis Investigative Site

Recruiting

Wels,A 4600,Austria

Novartis Investigative Site

Recruiting

Linz,4010,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

Hangzhou,Zhejiang,310003,China

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

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

University of Pennsylvania

Recruiting

Philadelphia,Pennsylvania,19104,United States

Adam Cuker
Emmanuel Ndukwudimma

Boston Medical Center

Recruiting

Boston,Massachusetts,02118,United States

J Mark Sloan

Hematology Oncology Association of Rockland

Recruiting

Nyack,New York,10960,United States

Sung Ho Lee
Marion VanWoudenberg

UMASS Memorial Medical Center

Recruiting

Worcester,Massachusetts,01665,United States

Daniel Winokur
Lindsey Allen

Community Cancer Institute

Recruiting

Clovis,California,93611,United States

Mohammed Bukari

STAT Research Inc Premier Clin Res LLC STAT Res

Recruiting

Dayton,Ohio,45402,United States

Charles Bane

NorthShore University Health System

Recruiting

Evanston,Illinois,60201,United States

Michele Britto
Amy Wang

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
Sibian Torres

Summit Health

Recruiting

Florham Park,New Jersey,07932,United States

David Gallinson

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
Sara Moellering

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
Noelle Townsend

Compassionate Care Res Group Inc

Recruiting

Fountain Valley,California,92708,United States

Eric Lee

Texas Oncology Drug Ship 5

Recruiting

Dallas,Texas,75251,United States

Racha Halawi

Clinical Research Alliance Research

Recruiting

Lake Success,New York,11042,United States

James D Olimpio
William Krenn

Parkview Research Center .

Recruiting

Fort Wayne,Indiana,46845,United States

Jeffrey Letzer

University of Colorado Anschutz

Recruiting

Aurora,Colorado,80045,United States

George Gemlyn

Napa Research

Recruiting

Margate,Florida,33063,United States

Emilio Araujo-Mino

St Vincent Frontier Cancer Center .

Recruiting

Billings,Montana,59102,United States

Amanda Klein
Patrick Cobb

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