New drug combo shows promise for rare autoimmune disease
NCT ID NCT04520451
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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27 people
The number who actually took part.
- Started
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Aug 2020
- Finished
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Oct 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Investigational Site Number 12403
Vancouver, V6K 2V8, Canada
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Investigational Site Number 25013
Marseille, France
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Investigational Site Number 38016
Milan, Italy
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Investigational Site Number 72415
Barcelona, Spain
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Investigational Site Number 84016
Boston, Massachusetts, 02114, United States
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Investigational Site Number 84018
Detroit, Michigan, 48202, United States
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Investigational Site Number 84019
Stanford, California, 94305, United States
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Investigational Site Number 84030
New York, New York, 10021, United States
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Investigational Site Number 84036
Portland, Oregon, 97239, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a JAK inhibitor boost remission in IgG4-Related disease?
- Investigational drug AMG 335 offered to adults with IgG4-Related disease
- Can inhaled cell vesicles soothe damaged lungs in autoimmune disease?
- Can engineered immune cells tame a stubborn autoimmune disease?
- A steroid-sparing strategy for IgG4-related disease: lenalidomide put to the test
- New drug aims to stop IgG4 disease relapses without Long-Term steroids