ClinPharm Vault

Remibrutinib versus dupilumab Phase 3b CSU study (NCT06868212)

Study Snapshot

Conditions: Chronic Spontaneous Urticaria (CSU)
Sex: ALL
Age range: 18 Years to None
Healthy volunteers: False
Summary: This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily [b.i.d.] by mouth [p.o.]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.

Arms represented in current CT.gov export: 2
Active dose regimens represented in current local source layer: 2
Total study enrollment in CT.gov: 400 (ESTIMATED)
Per-arm sample size summary: 400 total with a 1:1 allocation schema across 2 listed arms; exact arm-specific counts are not explicitly stated in the current local source text.
Arm-size evidence source: ClinicalTrials.gov arm descriptions and summary text.

Arm	Type	Dose	Frequency	Route	Description	N	Evidence status
Treatment group 1: Remibrutinib + Placebo	EXPERIMENTAL	25 mg	BID + Q2W	Subcutaneous + Oral	Remibrutinib tablet (25 mg b.i.d. p.o.) + placebo solution for injection in pre-filled syringe (2 s.c. injections at baseline and then 1 s.c. injection every other week [Weeks 2-10])	NR	Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer
Treatment group 2: Dupilumab + remibrutinib matching placebo	ACTIVE_COMPARATOR	600 mg -> 300 mg	BID + Q2W	Subcutaneous + Oral	Dupilumab pre-filled syringe (600 mg loading dose [2 x 300 mg dupilumab s.c. injection] at baseline visit followed by dupilumab 300 mg s.c. injection every other week [Weeks 2-10]) + remibrutinib matching placebo tablet (1 tablet b.i.d. p.o.)	NR	Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer

CT.gov describes a double-blind double-dummy study comparing remibrutinib against dupilumab in inadequately controlled adult CSU.
The primary endpoint is absolute change from baseline in UAS7 at week 4, emphasizing early efficacy differentiation.

Primary outcomes:
Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 (time frame: Baseline, Week 4)

PK: Not clearly summarized in the currently linked local source snippets.
PD: Not clearly summarized in the currently linked local source snippets.
Linked manuscripts: No trial-level primary publication is explicitly linked in the current registry.

Safety detail is not strongly enriched beyond the current CT.gov/source-registry layer.

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 is currently represented mainly by CT.gov and any linked sponsor-source artifacts; manual enrichment is still needed for a richer narrative page.
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 explicit trial-level primary manuscript is currently linked in the registry.
No sponsor artifact is explicitly linked to this trial by identifier in the current registry.

Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
Primary source(s):
NCT06868212
../raw/clinicaltrials/markdown/NCT06868212.md
../inventories/source_registry.json
Supporting source(s):
../inventories/ctgov_priority_trials.json
Last verified: 2026-04-08
Verification status: Partial

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