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New pill shows promise for rare bleeding disorder

NCT ID NCT03395210

Disease control Sponsor: Principia Biopharma, a Sanofi Company 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an experimental oral drug called rilzabrutinib in 86 adults with relapsed immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, raising bleeding risk. The drug aims to block a key immune signal to help raise platelet counts. The trial looked at safety and how well the drug worked at different doses.

What this could mean

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

Active substance
Rilzabrutinib (an oral BTK inhibitor)
What this could lead to
If successful, this could offer a new oral treatment option for people with relapsed immune thrombocytopenia who have few alternatives.
What could go wrong
This is a relatively small, early-phase study (Phase 1/2) with no placebo comparison. The results may not hold up in larger trials, and side effects are still being evaluated.

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

86 people

The number who actually took part.

Started

Mar 2018

Finished

Dec 2025

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 80 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: * Male or female patients, aged 18 to 80 years old * Immune-related ITP (both primary and secondary) Exclusion Criteria: * Pregnant or lactating women * Current drug or alcohol abuse * History of solid organ transplant * Positive screening for HIV, hepatitis B, or hepatitis C

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Conditions

The condition(s) this trial relates to.

Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

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

Immune thrombocytopenia

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center- Site Number : 1099

    Boston, Massachusetts, 02215, United States

  • Bleeding and Clotting Disorders Institute- Site Number : 1087

    Peoria, Illinois, 61614-2868, United States

  • Investigational Site Number : 101

    Clayton, Victoria, 3168, Australia

  • Investigational Site Number : 102

    Woolloongabba, Queensland, 4102, Australia

  • Investigational Site Number : 103

    Perth, Western Australia, 6005, Australia

  • Investigational Site Number : 104

    Sydney, New South Wales, 2139, Australia

  • Investigational Site Number : 105

    Canberra, Australian Capital Territory, 2605, Australia

  • Investigational Site Number : 106

    Parkville, Victoria, 3050, Australia

  • Investigational Site Number : 1161

    Toronto, Ontario, M5B 1W8, Canada

  • Investigational Site Number : 1162

    Montreal, Quebec, H3A 1A1, Canada

  • Investigational Site Number : 211

    Varna, 9010, Bulgaria

  • Investigational Site Number : 213

    Pleven, 5800, Bulgaria

  • Investigational Site Number : 214

    Sofia, 1431, Bulgaria

  • Investigational Site Number : 431

    Brno, 62500, Czechia

  • Investigational Site Number : 432

    Prague, 12808, Czechia

  • Investigational Site Number : 433

    Hradec Králové, 50005, Czechia

  • Investigational Site Number : 434

    Ostrava - Poruba, 70852, Czechia

  • Investigational Site Number : 541

    Grålum, 1714, Norway

  • Investigational Site Number : 542

    Bergen, N-5021, Norway

  • Investigational Site Number : 727

    Rotterdam, 3015 GD, Netherlands

  • Investigational Site Number : 728

    The Hague, 2545 CH, Netherlands

  • Investigational Site Number : 980

    London, London, City of, W12 0HS, United Kingdom

  • Investigational Site Number : 981

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Investigational Site Number : 983

    London, London, City of, E1 2ES, United Kingdom

  • Investigational Site Number : 984

    Birmingham, B15 2GW, United Kingdom

  • Massachusetts General Hospital Cancer Center- Site Number : 1092

    Boston, Massachusetts, 02114-2603, United States

  • Mid Michigan Medical Center- Site Number : 1086

    Midland, Michigan, 48670, United States

  • New York Presbyterian Hospital/Weill Cornell Medical Center- Site Number : 1097

    New York, New York, 10021, United States

  • Pitt County Memorial Hospital- Site Number : 1095

    Greenville, North Carolina, 27834, United States

  • RCCA MC LLC- Site Number : 1091

    Bethesda, Maryland, 20817-1915, United States

  • Seattle Cancer Care Alliance Site Number : 1098

    Seattle, Washington, 98109-4405, United States

More trials for these conditions

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