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New drug combo shows promise for rare autoimmune disease

NCT ID NCT04520451

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new drug called rilzabrutinib combined with steroids in 27 adults with active IgG4-related disease, a rare condition causing inflammation and organ damage. The goal was to see if the combination could prevent disease flares better than steroids alone. Participants took the drug daily and were monitored for safety and disease activity.

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

27 people

The number who actually took part.

Started

Aug 2020

Finished

Oct 2024

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 years and older

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: * Be male or female with age ≥18 years. * Have a clinical diagnosis of IgG4-RD. * Be willing to taper off an equivalent prednisone dose of between 20-40 mg/day in 2 weeks. Key Exclusion Criteria: * Currently or within 6 months of screening taking rituximab, other B-cell depleting agents, or alkylating agents unless B cell concentrations have been demonstrated by flow cytometry to return to normal values (defined as 5 cells per cubic mm). * History of solid organ transplant * Positive at Screening for HIV, hepatitis B, hepatitis C, or TB * Female patients who are pregnant or nursing. * NOTE: Other Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Immunoglobulin G4-Related Disease immunoglobulin G4-related sclerosing disease

As listed by the trial registrant

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

Contacts and locations

Locations

  • Investigational Site Number 12403

    Vancouver, V6K 2V8, Canada

  • Investigational Site Number 25013

    Marseille, France

  • Investigational Site Number 38016

    Milan, Italy

  • Investigational Site Number 72415

    Barcelona, Spain

  • Investigational Site Number 84016

    Boston, Massachusetts, 02114, United States

  • Investigational Site Number 84018

    Detroit, Michigan, 48202, United States

  • Investigational Site Number 84019

    Stanford, California, 94305, United States

  • Investigational Site Number 84030

    New York, New York, 10021, United States

  • Investigational Site Number 84036

    Portland, Oregon, 97239, United States

More trials for these conditions

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