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Second dose of experimental drug may help when first fails

NCT ID NCT07039422

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tests whether a second course of ianalumab can help adults with two rare blood disorders—immune thrombocytopenia (ITP) and warm-antibody autoimmune hemolytic anemia (wAIHA)—who previously responded to the drug but then stopped responding. About 60 participants will receive ianalumab by IV infusion. The goal is to see if it can control the disease again without major side effects.

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 show that a second course of ianalumab helps control ITP or wAIHA when the first course stops working.
What could go wrong
This is a small, early-phase study (60 people) with no placebo group, so results may not be definitive. Risks include infusion reactions and infections.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

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 Primary ITP patients: * Previously enrolled and treated either with ianalumab/placebo in addition to first-line corticosteroids on protocol CVAY736I12301 or with ianalumab/placebo in addition to eltrombopag in the second line on protocol CVAY736Q12301, and who experienced treatment failure (TF) by parent trial definition ≥ 2 years after the last infusion of ianalumab/placebo * Rescue medication and/or bridging therapy are allowed to be started within the 28 days prior to screening; platelet count results obtained prior to the start of the therapy must be used to assess eligibility and have to be collected within 30 days prior to screening For Primary or Secondary wAIHA patients: * Previously documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA, previously enrolled and treated with ianalumab/placebo in blinded cohort or placebo followed by crossover to open label ianalumab in protocol CVAY736O12301, having experienced durable response lasting beyond 2 years from the last infusion of ianalumab/placebo in blinded cohorts or a durable response beyond week 20 from last dose of first course of ianalumab in the crossover arm. * Relapsed wAIHA with hemoglobin concentration ≥5 g/dL and \<10 g/dL and presence of symptoms related to anemia during screening or within 14 days before screening window or within 28 days before screening window if rescue medication/bridging therapy has been initiated. * Rescue medication and/or bridging therapy are allowed to be started during the screening and within 28 days prior to screening; hemoglobin level result for eligibility assessment needs to be obtained prior to the start of the treatment within 30 days prior to screening * Supportive care is allowed in the case the participant received it in the parent trial when the relapse occurred and has remained stable at least 4 weeks prior screening Exclusion Criteria: * Evans syndrome or any cytopenia other than thrombocytopenia (for ITP participants) or anemia (for wAIHA), except for grade 1 anemia due to blood loss or iron deficiency. * Secondary wAIHA with BM involvement for wAIHA patients * Current life-threatening bleeding or history of life-threatening bleeding due to thrombocytopenia * Therapy for ITP or wAIHA other than ianalumab/placebo, bridging/rescue therapies and supportive care prior to the beginning of the screening window * After primary analysis of each respective parent trial, participants whose treatment was unblinded and who received placebo only will be excluded. * ITP participants only: Participants with concurrent coagulation disorders and/or receiving anti-platelet or anti-coagulant medication except for low dose of acetylsalicylic acid (≤150 mg per day) Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia, warm type 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 Warm autoimmune hemolytic anemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    WITHDRAWN

    Buenos Aires, C1039AAC, Argentina

  • Novartis Investigative Site

    RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    RECRUITING

    Dalian, Liaoning, 116023, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300020, China

  • Novartis Investigative Site

    RECRUITING

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    RECRUITING

    Caen, 14033, France

  • Novartis Investigative Site

    RECRUITING

    Rennes, 35033, France

  • Novartis Investigative Site

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    RECRUITING

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    RECRUITING

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    RECRUITING

    Trieste, TS, 34129, Italy

  • Novartis Investigative Site

    RECRUITING

    Vicenza, VI, 36100, Italy

  • Novartis Investigative Site

    RECRUITING

    George Town, 10050, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Johor Bahru, 80100, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Kuala Selangor, 68000, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Bucharest, 030171, Romania

  • Novartis Investigative Site

    RECRUITING

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28009, Spain

  • Novartis Investigative Site

    RECRUITING

    Murcia, 30008, Spain

  • Novartis Investigative Site

    RECRUITING

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Ankara, Bilkent Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    London, W12 0HS, United Kingdom

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