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Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine

Study Snapshot

  • Program: Rilzabrutinib
  • Study ID(s): NCT05107115
  • Phase: Phase 2
  • Indication: Chronic Spontaneous Urticaria
  • Status: Completed
  • Sponsor: Sanofi

Design

  • Study type: INTERVENTIONAL
  • Randomization / allocation: RANDOMIZED
  • Intervention model: PARALLEL
  • Masking: QUADRUPLE
  • Primary purpose: TREATMENT
  • Enrollment: 161 (ACTUAL)

Population

  • Conditions: Chronic Spontaneous Urticaria
  • Sex: ALL
  • Age range: 18 Years to 80 Years
  • Healthy volunteers: False
  • Summary: The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. dose A, B and C, compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU.

After completion of the double-blind phase of the study, participants will be given the option of enrolling in the 40-week open label extension (OLE) phase of the study. Participants will receive open-label rilzabrutinib at dose C (the dose may be modified based on the 12-week safety and efficacy data). Due to the fact that some participants may be receiving rilzabrutinib for the first time, all participants will be monitored at Week 14, Week 16, Week 20, and Week 24. Afterwards, participants will be monitored at Week 36 and Week 52.

Operational design summary

  • Arms represented in current CT.gov export: 4
  • Active dose regimens represented in current local source layer: 3
  • Total study enrollment in CT.gov: 161 (ACTUAL)
  • Design interpretation: 4-arm phase 2 dose-ranging study with three oral rilzabrutinib regimens plus placebo.
  • Per-arm sample size summary: PMCID full text directly supports randomized sizes of 400 mg/d n=38, 800 mg/d n=41, 1200 mg/d n=41, and placebo n=40 overall; it also reports primary-analysis sample sizes of placebo n=36, 400 mg/d n=37, 800 mg/d n=35, and 1200 mg/d n=35.
  • Arm-size evidence source: PMID 40266575 abstract plus PMCID PMC12019677 full text; CT.gov dose A/B/C rows are mapped to the publication regimen order (400 mg QPM, 400 mg BID, 400 mg TID).

Arms

Arm Type Dose Frequency Route Description N Evidence status
Rilzabrutinib dose A EXPERIMENTAL 400 mg QPM Oral dose A 38 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Rilzabrutinib dose B EXPERIMENTAL 400 mg BID Oral dose B 41 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Rilzabrutinib dose C EXPERIMENTAL 400 mg TID Oral dose C 41 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context
Placebo PLACEBO_COMPARATOR NR Matched oral placebo Oral Matching placebo 40 Directly supported by linked local publication/source text or explicit CT.gov arm-level enrollment context

Key Efficacy and Safety Findings

  • Result status: Published

Efficacy

  • Primary endpoint (ISS7 change at week 12, 1200 mg/d versus placebo, omalizumab-naive): LS mean -9.21 versus -5.77; difference -3.44 (95% CI -6.25 to -0.62; P = 0.02).
  • UAS7 change at week 12 (1200 mg/d versus placebo): LS mean -16.89 versus -10.14; difference -6.75 (95% CI -12.23 to -1.26; P = 0.02).
  • Well-controlled disease (UAS7 <= 6) at week 12: 34.3% versus 11.1% (difference 20.3%).
  • Rapid onset: improvements in ISS7, UAS7, HSS7, and AAS7 observed as early as week 1.
  • Exploratory biomarkers (1200 mg/d): IgG anti-FcεRI -38.7%, IgG anti-TPO -46.7% versus placebo.

Safety

  • Favorable risk-benefit; no dose-dependent AEs; most frequent AEs: diarrhea and nausea (mild).
  • No cytopenia, bleeding, or atrial fibrillation events (distinguishing from older irreversible BTKIs).
  • 3 SAEs total, none related to rilzabrutinib.
  • ALT > 3x ULN: 4 cases total across arms; all resolved, 3 while continuing drug.

Result source(s)

  • PMID 40266575
  • PMCID PMC12019677

Endpoints

  • Primary outcomes:
  • Change from baseline in weekly urticaria activity score (UAS7) at Week 12 (except US and US reference countries) (time frame: From baseline to Week 12)
  • For US and US reference countries only: change from baseline in weekly itch severity score (ISS7) at Week 12 (time frame: From baseline to Week 12)

Clinical Pharmacology Findings

  • PK: Not clearly summarized in the currently linked local source snippets.
  • PD: Not clearly summarized in the currently linked local source snippets.
  • Linked manuscripts: Primary publication support is available in the registry (PMID 40266575).

Safety Findings

  • Safety details should be reviewed in the linked primary publication(s) for fuller interpretation beyond the CT.gov inventory layer.

Linked Evidence

  • CT.gov page: https://clinicaltrials.gov/study/NCT05107115
  • Local CT.gov cache: raw/clinicaltrials/markdown/NCT05107115.md
  • Primary publications:
  • PMID 40266575: Rilzabrutinib in Antihistamine-Refractory Chronic Spontaneous Urticaria: The RILECSU Phase 2 Randomized Clinical Trial. (../raw/publications/pubmed/markdown/PMID40266575.md)

Interpretation

  • Verified facts: this page reflects the current local registry and CT.gov inventory export without inferring unsupported arm sizes or endpoint results.
  • Interpretation: this trial already has direct manuscript support in the local source layer and should be a higher-priority candidate for manual enrichment.
  • Open questions:
  • Some studies still lack exact arm-specific N in the current promoted evidence layer even when allocation schema or total enrollment is visible.
  • No sponsor artifact is explicitly linked to this trial by identifier in the current registry.

Provenance

  • Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
  • Primary source(s):
  • NCT05107115
  • ../raw/clinicaltrials/markdown/NCT05107115.md
  • ../inventories/source_registry.json
  • Supporting source(s):
  • ../inventories/ctgov_priority_trials.json
  • Last verified: 2026-04-08
  • Verification status: Partial

Change Log

  • 2026-04-08: Generated or refreshed this study page from the v2 source registry and CT.gov inventory.