Trial · NCT07190196
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
NCT07190196, Phase 3, Recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease. Trials, record NCT07190196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07190196
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease
- NCT number
- NCT07190196
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 124 participants, estimated
- Lead sponsor
- Sanofi
- Conditions
- Immunoglobulin G4 Related Disease
- Interventions
- Rilzabrutinib, Placebo, Glucocorticoid
- First posted
- 2025-09-24
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to first adjudicated clinical disease flare treated by the investigator during the Blinded Treatment period | Until Week 52 | The Adjudication Committee will include internationally recognized independent experts in diagnosis and management of patients with IgG4-RD, blinded to participant, investigator, and site identifiers |
| Secondary | Proportion of participants without IgG4-RD adjudicated clinical disease flare and off glucocorticoids and immunomodulators | At Week 52 | |
| Secondary | Proportion of participants without IgG4-RD adjudicated clinical disease flare and off glucocorticoids | At Week 52 | |
| Secondary | Annualized rate of clinical disease flares | At Week 52 | |
| Secondary | Change in IgG4-RD RI total activity scores from baseline to Week 52 | From baseline to Week 52 | |
| Secondary | Proportion of participants in complete remission at Week 52 | At Week 52 | Defined by an IgG4-RD RI total activity score = 0 or absence of evident disease activity assessed by the Investigator |
| Secondary | Percent change in IgG4-RD RI total activity scores from baseline to Week 52 | From baseline to Week 52 | |
| Secondary | Change in IgG4-RD RI total activity scores from baseline to Week 12 | From baseline to Week 12 | |
| Secondary | Percent change in IgG4-RD RI total activity scores from baseline at Week 12 | From baseline to Week 12 | |
| Secondary | Proportion of participants with reduction of ≥2 points from the baseline IgG4-RD RI total activity score | At Week 12, Week 24, and Week 52 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07190196
GET https://conductscience.org/api/trials/v1/NCT07190196/registered