# Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.

> **NCT06042478** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 470 (actual)

## Conditions studied

- Chronic Spontaneous Urticaria

## Interventions

- **DRUG:** Remibrutinib
- **DRUG:** Placebo to remibrutinib
- **DRUG:** Placebo to omalizumab
- **DRUG:** Omalizumab

## Key facts

- **NCT ID:** NCT06042478
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-11-15
- **Primary completion:** 2025-09-17
- **Final completion:** 2027-07-20
- **Target enrollment:** 470 (ACTUAL)
- **Last updated:** 2026-03-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06042478

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06042478, "Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT06042478. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*