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New hope for ITP patients: experimental drug aims to boost platelets

NCT ID NCT05885555

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This phase 2 trial tests an experimental drug called ianalumab in 41 adults with primary immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding. Participants have already tried steroids and another standard treatment. The study measures whether ianalumab can safely raise platelet counts to a safe level.

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 successful, this could offer a new treatment option for people with ITP whose disease hasn't responded well to standard therapies.
What could go wrong
This is a small, early-phase trial with only 41 participants, so results may not apply to everyone. The drug may not work or could cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

41 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Mar 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 obtained prior to participation in the study. * Male or female participants aged 18 years and older on the day of signing informed consent. * Confirmed diagnosis of primary ITP. * Prior treatment with at least a corticosteroid (±IVIG) and a TPO-RA: * Prior additional therapies are allowed; the corticosteroid or the TPO-RA do not need to be the last treatment. * Prior response to IVIG/anti-D or a corticosteroid (platelet count ≥50 G/L) that was not maintained. * At last ITP treatment, loss of response, insufficient response, no response or intolerance. * Platelet count \<30 G/L and assessed as needing treatment (per physician's discretion) at screening. If concomitant ITP medication is clinically indicated, the platelet assessment showing a value \<30 G/L must be performed after at least 14 days on a stable dose of a corticosteroid or/and a TPO-RA (less than 10% variation from current dose) and continue stable thereafter. Key exclusion criteria: * Diagnosis of secondary thrombocytopenia. * Platelet or whole blood transfusion, plasmapheresis, or use of any other rescue medications within 14 days before first ianalumab infusion. * Participants with the following conditions at screening: * Neutrophils \<1000/mm3. * Immunoglobulin G (IgG) \<5 g/L * Treatment with a B-cell depleting therapy (e.g., rituximab) or anti-B-cell Activating Factor of the TNF Family (BAFF) (e.g., belimumab) within 12 weeks prior to the first administration of ianalumab. * Immunosuppressant drugs other than corticosteroids within 5 times the elimination half-life of the drug or 14 days before first ianalumab infusion, whichever is longer. * Prior splenectomy. 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 (ITP)

Contacts and locations

Locations

  • Beth Israel Deaconess Med Center

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    Garran, Australian Capital Territory, 2605, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Jinan, 250012, China

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Giessen, 35392, Germany

  • Novartis Investigative Site

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    Johor Bahru, 80100, Malaysia

  • Novartis Investigative Site

    Katowice, 40-519, Poland

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    Aydin, Efeler, 09100, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Edirne, Merkez, 22030, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    Kocaeli, 41380, Turkey (Türkiye)

  • Novartis Investigative Site

    Glasgow, G31 2ER, United Kingdom

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

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