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Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

NCT ID: NCT05653349

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-03

Study Completion Date

2028-09-29

Brief Summary

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The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.

Detailed Description

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This is a multi-center, randomized, double-blind Phase 3 study to assess the efficacy and safety of two different doses of ianalumab compared to placebo in adults with primary ITP (platelets count \<30 G/L) who require first-line standard-of-care corticosteroids.

After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with standard of care corticosteroids).

After the treatment period, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how they respond to the study treatment.

Conditions

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Primary Immune Thrombocytopenia (ITP)

Keywords

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Primary immune thrombocytopenia (ITP) ianalumab VAY736 B-cell depletion B-cell Activating Factor Receptor (BAFF-R) blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ianalumab Lower dose

Lower dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)

Group Type EXPERIMENTAL

Corticosteroids

Intervention Type DRUG

Oral or parental (if clinically justified)

Ianalumab

Intervention Type BIOLOGICAL

Intravenous infusion, prepared from concentrate solution

Ianalumab Higher dose

Higher dose of ianalumab administered intravenously with corticosteroids oral or parental (if clinically justified)

Group Type EXPERIMENTAL

Corticosteroids

Intervention Type DRUG

Oral or parental (if clinically justified)

Ianalumab

Intervention Type BIOLOGICAL

Intravenous infusion, prepared from concentrate solution

Placebo

Placebo administered intravenously with corticosteroids oral or parental (if clinically justified)

Group Type PLACEBO_COMPARATOR

Corticosteroids

Intervention Type DRUG

Oral or parental (if clinically justified)

Placebo

Intervention Type DRUG

Intravenous infusion, prepared from matching placebo

Interventions

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Corticosteroids

Oral or parental (if clinically justified)

Intervention Type DRUG

Ianalumab

Intravenous infusion, prepared from concentrate solution

Intervention Type BIOLOGICAL

Placebo

Intravenous infusion, prepared from matching placebo

Intervention Type DRUG

Other Intervention Names

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VAY736

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent prior to participation in the study.
* Male or female participants aged 18 years and older on the day of signing informed consent
* Primary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG)
* Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG)
* Response (platelet count \>=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response.

Exclusion Criteria

* Evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible)
* Current life-threatening bleeding
* Previous ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .
* Prior use of B-cell depleting therapy (e.g., rituximab).
* Absolute neutrophil count below 1.0 G/L at randomization
* Participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid

Other protocol-defined Inclusion/Exclusion may apply.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Yuma Regional Medical Center

Yuma, Arizona, United States

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Community Cancer Institute

Clovis, California, United States

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Compassionate Care Res Group Inc

Fountain Valley, California, United States

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University of Colorado Anschutz

Aurora, Colorado, United States

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DH Cancer Research Center LLC

Margate, Florida, United States

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Uni of Chi Medi Ctr Hema and Onco

Chicago, Illinois, United States

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Parkview Research Center

Fort Wayne, Indiana, United States

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Oncology Care Associates

Bethesda, Maryland, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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Beth Israel Deaconess Med Center

Boston, Massachusetts, United States

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Michigan Center of Medical Research

Farmington Hills, Michigan, United States

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Mayo Clinic Rochester

Rochester, Minnesota, United States

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Metro Minnesota CCOP

Saint Louis Park, Minnesota, United States

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St Vincent Frontier Cancer Center

Billings, Montana, United States

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Clinical Research Alliance

Lake Success, New York, United States

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Hematology Oncology Association of Rockland

Nyack, New York, United States

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

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STAT Research Inc

Dayton, Ohio, United States

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Rhode Island Hospital

Providence, Rhode Island, United States

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Mays Cancer Ctr Uthsa Mdacc

San Antonio, Texas, United States

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Community Cancer Trials of Utah

Ogden, Utah, United States

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Novartis Investigative Site

CABA, Buenos Aires, Argentina

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CABA, Buenos Aires, Argentina

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San Miguel Tucuman, Tucumán Province, Argentina

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Caba, , Argentina

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Caba, , Argentina

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Córdoba, , Argentina

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Garran, Australian Capital Territory, Australia

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Wooloongabba, Queensland, Australia

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Clayton, Victoria, Australia

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Melbourne, Victoria, Australia

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Innsbruck, Tyrol, Austria

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Salzburg, , Austria

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Roeselare, West-Vlaanderen, Belgium

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Brasschaat, , Belgium

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Bruges, , Belgium

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Leuven, , Belgium

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Beijing, Beijing Municipality, China

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Guangzhou, Guangdong, China

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Shenzhen, Guangdong, China

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Shijiazhuang, Hebei, China

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Luoyang, Henan, China

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Zhengzhou, Henan, China

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Wuhan, Hubei, China

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Changzhou, Jiangsu, China

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Nanchang, Jiangxi, China

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Xi'an, Shaanxi, China

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Chengdu, Sichuan, China

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Kunming, Yunnan, China

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Hangzhou, Zhejiang, China

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Bengbu, , China

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Dalian, , China

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Tianjin, , China

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Ostrava, Poruba, Czechia

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Brno, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Caen, , France

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Chambéry, , France

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Lille, , France

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Rennes, , France

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Frankfurt am Main, Hesse, Germany

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Dresden, Saxony, Germany

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Jena, Thuringia, Germany

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Dresden, , Germany

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Essen, , Germany

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Giessen, , Germany

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New Territories, Hong Kong, Hong Kong

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Hong Kong, , Hong Kong

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Debrecen, Hajdu Bihar Megye, Hungary

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Budapest, , Hungary

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Ahmedabad, Gujarat, India

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Mumbai, Maharashtra, India

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Rishikesh, Uttarakhand, India

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Kolkata, West Bengal, India

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Bologna, BO, Italy

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Florence, FI, Italy

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Roma, RM, Italy

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Trieste, TS, Italy

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Vicenza, VI, Italy

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Nagakute, Aichi-ken, Japan

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Shibukawa, Gunma, Japan

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Sapporo, Hokkaido, Japan

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Okayama, Okayama-ken, Japan

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Iruma-gun, Saitama, Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Gifu, , Japan

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Osaka, , Japan

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Kuching, Sarawak, Malaysia

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George Town, , Malaysia

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Johor Bahru, , Malaysia

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Kuala Selangor, , Malaysia

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico CP, Mexico

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Morelia, Michoacán, Mexico

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Monterrey, Nuevo León, Mexico

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Grålum, , Norway

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Bucharest, , Romania

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Bucharest, , Romania

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Singapore, , Singapore

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Singapore, , Singapore

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Murcia, , Spain

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Salamanca, , Spain

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Seville, , Spain

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Samsun, Atakum, Turkey (Türkiye)

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Aydin, Efeler, Turkey (Türkiye)

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Istanbul, Fatih, Turkey (Türkiye)

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Birmingham, West Midlands, United Kingdom

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London, , United Kingdom

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Nottingham, , United Kingdom

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Hanoi, , Vietnam

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Ho Chi Minh City, , Vietnam

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Countries

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United States Argentina Australia Austria Belgium Bulgaria China Czechia France Germany Hong Kong Hungary India Italy Japan Malaysia Mexico Norway Romania Singapore Spain Thailand Turkey (Türkiye) United Kingdom Vietnam

Other Identifiers

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CVAY736I12301

Identifier Type: -

Identifier Source: org_study_id