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New biologic aims to stabilize platelet counts in ITP patients

NCT ID NCT05653349

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding ianalumab (a biologic drug) to standard corticosteroids helps adults with newly diagnosed immune thrombocytopenia (ITP) achieve a stable platelet response off all treatments at 12 months. About 226 participants will receive either ianalumab or a placebo alongside corticosteroids. The goal is to see if ianalumab can improve long-term disease control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ianalumab (a biologic drug given by IV infusion)
What this could lead to
If it works, this could offer a new first-line option for adults with ITP, helping more people achieve stable platelet counts without needing long-term treatment.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may not improve response rates over placebo, and side effects from the biologic or corticosteroids could occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

226 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Key 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.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura primary thrombocytopenia Purpura, Thrombocytopenic, Idiopathic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary immune thrombocytopenia (ITP)

Contacts and locations

Locations

  • Beth Israel Deaconess Med Center

    Boston, Massachusetts, 02215, United States

  • Community Cancer Institute

    Clovis, California, 93611, United States

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

  • Compassionate Care Res Group Inc

    Fountain Valley, California, 92708, United States

  • DH Cancer Research Center LLC

    Margate, Florida, 33063, United States

  • Hematology Oncology Association of Rockland

    Nyack, New York, 10960, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Mays Cancer Ctr Uthsa Mdacc

    San Antonio, Texas, 78229, United States

  • Metro Minnesota CCOP

    Saint Louis Park, Minnesota, 55416, United States

  • Michigan Center of Medical Research

    Farmington Hills, Michigan, 48334, United States

  • Novartis Investigative Site

    CABA, Buenos Aires, C1280AEB, Argentina

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414DRK, Argentina

  • Novartis Investigative Site

    San Miguel Tucuman, Tucumán Province, T4000DPK, Argentina

  • Novartis Investigative Site

    Caba, C1039AAC, Argentina

  • Novartis Investigative Site

    Córdoba, 5000, Argentina

  • Novartis Investigative Site

    Garran, Australian Capital Territory, 2605, Australia

  • Novartis Investigative Site

    Wooloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Salzburg, 5020, Austria

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    Brasschaat, 2930, Belgium

  • Novartis Investigative Site

    Bruges, 8000, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Plovdiv, 4002, Bulgaria

  • Novartis Investigative Site

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100044, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518037, China

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000, China

  • Novartis Investigative Site

    Luoyang, Henan, 471003, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    Changzhou, Jiangsu, 213004, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    Kunming, Yunnan, 650101, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006, China

  • Novartis Investigative Site

    Bengbu, 233004, China

  • Novartis Investigative Site

    Dalian, 116000, China

  • Novartis Investigative Site

    Tianjin, 300020, China

  • Novartis Investigative Site

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    Prague, 100 34, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Caen, 14033, France

  • Novartis Investigative Site

    Chambéry, 73000, France

  • Novartis Investigative Site

    Le Mans, 72000, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Rennes, 35033, France

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Giessen, 35392, Germany

  • Novartis Investigative Site

    New Territories, Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, H-1083, Hungary

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380013, India

  • Novartis Investigative Site

    Rishikesh, Uttarakhand, 249203, India

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Trieste, TS, 34129, Italy

  • Novartis Investigative Site

    Vicenza, VI, 36100, Italy

  • Novartis Investigative Site

    Nagakute, Aichi-ken, 480-1195, Japan

  • Novartis Investigative Site

    Shibukawa, Gunma, 377-0280, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608604, Japan

  • Novartis Investigative Site

    Okayama, Okayama-ken, 7011192, Japan

  • Novartis Investigative Site

    Iruma-gun, Saitama, 3500495, Japan

  • Novartis Investigative Site

    Chiba, 260-0852, Japan

  • Novartis Investigative Site

    Fukuoka, 815-8555, Japan

  • Novartis Investigative Site

    Gifu, 5008513, Japan

  • Novartis Investigative Site

    Osaka, 543-8555, Japan

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    George Town, 10050, Malaysia

  • Novartis Investigative Site

    Johor Bahru, 80100, Malaysia

  • Novartis Investigative Site

    Kuala Selangor, 68000, Malaysia

  • Novartis Investigative Site

    Mexico City, Mexico City, 06720, Mexico

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    Grålum, 1714, Norway

  • Novartis Investigative Site

    Bucharest, 030171, Romania

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Murcia, 30008, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    Aydin, Efeler, 09100, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    Nottingham, NG5 1PB, United Kingdom

  • Novartis Investigative Site

    Hanoi, 100000, Vietnam

  • Novartis Investigative Site

    Ho Chi Minh City, 70000, Vietnam

  • Oncology Care Associates

    Bethesda, Maryland, 20817, United States

  • Optum Health

    Lake Success, New York, 11042, United States

  • Parkview Research Center

    Fort Wayne, Indiana, 46845, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • STAT Research Inc

    Dayton, Ohio, 45402, United States

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102, United States

  • Uni of Chi Medi Ctr Hema and Onco

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz

    Aurora, Colorado, 80045, United States

  • Yuma Regional Medical Center

    Yuma, Arizona, 85349, United States

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