A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines

Conditions

• Chronic Spontaneous Urticaria (CSU)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Remibrutinib — DRUG
  Film-coated tablet, oral administration, 25 mg b.i.d.
• Remibrutinib matching placebo — DRUG
  Film-coated tablet, oral administration, b.i.d.
• Dupilumab — DRUG
  Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks
• Placebo solution for injection — DRUG
  Solution for injection in pre-filled syringe every 2 weeks

Study Details

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.

Key Dates

First listed

Mar 10, 2025

Start date

Jul 11, 2025

Status verified

Jul 2026

Primary completion

Feb 22, 2027

Completion

May 17, 2027

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment group 1: Remibrutinib + Placebo
  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 \[Weeks 2-10\])
• Active Comparator: Treatment group 2: Dupilumab + remibrutinib matching placebo
  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.)

Primary Outcome Measure

Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) at Week 4 [ Time Frame: Baseline, Week 4 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals

Locations (130)

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