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New hope for chronic blood disorder: combo therapy aims to keep platelets stable

NCT ID NCT05653219

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 1 time

Summary

This study tests whether adding ianalumab to standard eltrombopag treatment helps adults with immune thrombocytopenia (ITP) who did not get better with steroids. ITP causes low platelet counts, raising bleeding risk. The trial involves 152 participants and measures how long the treatment works before failure. It is a phase 3, double-blind study, meaning neither patients nor doctors know who gets the extra drug.

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

152 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Apr 2028

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.

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.

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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

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Hematology Oncology Association of Rockland

    Nyack, New York, 10960, United States

  • Michigan Center of Medical Research

    Farmington Hills, Michigan, 48334, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Yvoir, Namur, 5530, Belgium

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Binzhou, Shandong, 256603, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Jinan, 250012, China

  • Novartis Investigative Site

    Tianjin, 300020, China

  • Novartis Investigative Site

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    Prague, 100 34, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Blois, 41000, France

  • Novartis Investigative Site

    Le Mans, 72000, France

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    Rishikesh, Uttarakhand, 249203, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700014, India

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Trieste, TS, 34129, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 453-8511, Japan

  • Novartis Investigative Site

    Osaka, Osaka, 5400006, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Kofu, Yamanashi, 400-8506, Japan

  • Novartis Investigative Site

    Kumamoto, 860-0008, Japan

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Kota Kinabalu, Sabah, 88586, Malaysia

  • Novartis Investigative Site

    Subang Jaya, Selangor, 47500, 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

    Saltillo, Coahuila, 25230, Mexico

  • Novartis Investigative Site

    Morelia, Michoacán, 58260, Mexico

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460, Mexico

  • Novartis Investigative Site

    Leiden, South Holland, 2333 ZA, Netherlands

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Makati City, 1229, Philippines

  • Novartis Investigative Site

    Quezon, 1102, Philippines

  • Novartis Investigative Site

    Craiova, Dolj, 200136, Romania

  • Novartis Investigative Site

    Timișoara, 300079, Romania

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Jeollanam, 519763, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Bilkent Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    Aydin, Efeler, 09100, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    London, E1 1BB, United Kingdom

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 7LE, United Kingdom

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102, United States

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01665, United States

  • University of Colorado Anschutz

    Aurora, Colorado, 80045, United States

  • Yuma Regional Medical Center

    Yuma, Arizona, 85349, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.