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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 March 2025 |
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Main ID: |
NCT04520451 |
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Date of registration:
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11/08/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants
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Scientific title:
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An Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008/SAR444671) on Safety and Disease Activity in Participants With IgG4-Related Disease |
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Date of first enrolment:
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August 22, 2020 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04520451 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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France
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Italy
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Spain
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Immunoglobulin G4 Related Disease
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Intervention(s)
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Drug: Glucocorticoids
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Drug: rilzabrutinib
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Primary Outcome(s)
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Proportion of participants who are without disease flare following the first dose of rilzabrutinib until the end of treatment
[Time Frame: Up to 64 weeks]
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Number of participants with Potentially clinically significant abnormalities (PCSAs) for clinical laboratory tests, vital signs and ECG
[Time Frame: Up to 68 weeks]
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Incidence of SAE, AE leading to discontinuation and possible glucocorticoid-related AE
[Time Frame: Up to 68 weeks]
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Secondary Outcome(s)
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Change from baseline over time in IgG4-RD damage, as recorded on the damage portion of the IgG4-RD RI over time
[Time Frame: From baseline up to 64 weeks]
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Level and change from baseline of each subclass of the serological markers over time
[Time Frame: Up to 64 weeks]
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Proportion of participants achieving reduction in baseline serum IgG4 level of 10% over time
[Time Frame: Up to 64 weeks]
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Proportion of patients with an IgG4-RD RI activity score = 0 over time
[Time Frame: Up to 64 weeks]
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Change from baseline in IgG4-RD RI over time
[Time Frame: From baseline up to 64 weeks]
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Proportion of participants with reduction from baseline IgG4-RD RI activity score by =2 points over time
[Time Frame: Up to 64 weeks]
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Secondary ID(s)
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U1111-1260-3972
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2022-002959-18
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ACT17125
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PRN1008-017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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