Phase 2 and 3 Placebo Controlled & Long-term Extension Study of Rilzabrutinib in Adults With iCVID to Evaluate Efficacy, Safety, and Tolerability
NCT07923305, Phase 2, Phase 3, Not yet recruiting, Sanofi
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Phase 2 and 3 Placebo Controlled & Long-term Extension Study of Rilzabrutinib in Adults With iCVID to Evaluate Efficacy, Safety, and Tolerability | ClinicalTrials.gov |
| NCT number | NCT07923305 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 96 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sanofi | ClinicalTrials.gov |
| Conditions | Immunodeficiency Common Variable | ClinicalTrials.gov |
| Interventions | rilzabrutinib, placebo | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of participants with iCVID who meet any responder definitions | At Week 32 | In participants with ILD at baseline, a responder is defined as achieving a clinically meaningful response at Week 32. In participants with cytopenia (thrombocytopenia, anemia) at baseline, a responder is defined as achieving therapeutic efficacy at Week 32, defined as Durable platelet response or Durable hemoglobin response (DHR) between W16 and W32, and no rescue medication for thrombocytopenia is taken at any time. In participants with lymphoproliferative disease (splenomegaly or lymphoid hyperplasia) at baseline, a responder is defined as achieving therapeutic efficacy by Week 32. | ClinicalTrials.gov |
| Secondary | Change from baseline in FACIT-Fatigue total score at Week 24 in Part A and Week 32 in Part B | At Week 24 in Part A and Week 32 in Part B | ClinicalTrials.gov | |
| Secondary | Percent change from baseline in FVC% predicted at Week 32 | At Week 32 | ClinicalTrials.gov | |
| Secondary | Percent change from baseline in diffusing capacity of the lung for carbon monoxide at Week 32 | At Week 32 | ClinicalTrials.gov | |
| Secondary | Change from baseline in FACIT-dyspnea severity score at Week 24 in Part A and Week 32 in Part B | At Week 24 in Part A and Week 32 in Part B | ClinicalTrials.gov | |
| Secondary | Change from baseline in time spend in moderate to vigorous physical activity measured with a wearable device | At Week 32 | ClinicalTrials.gov | |
| Secondary | Incidence of treatment-emergent adverse events (TEAE), serious AEs (SAE), TEAE leading to permanent discontinuation, adverse events of special interest (AESI) | Until Week 116 of LPI for Part D | including clinical laboratory evaluations, vital sign measurements, and electrocardiograms | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)