ClinPharm Vault
RELIEF remibrutinib early real-world effectiveness survey (NCT07408219)
Study Snapshot
- Program: Remibrutinib
- Study ID(s): NCT07408219
- Phase: NR
- Indication: Chronic Spontaneous Urticaria
- Status: Recruiting
- Sponsor: Novartis Pharmaceuticals
- Study family: Real-world evidence program
Design
- Study type: OBSERVATIONAL
- Randomization / allocation: None
- Intervention model: None
- Masking: None
- Primary purpose: None
- Enrollment: 350 (ESTIMATED)
Population
- Conditions: Chronic Spontaneous Urticaria
- Sex: ALL
- Age range: 18 Years to 100 Years
- Healthy volunteers: False
- Summary: This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients using validated patient reported outcome (PRO) tools.
Operational design summary
- Arms represented in current CT.gov export: 2
- Active dose regimens represented in current local source layer: NR
- Total study enrollment in CT.gov: 350 (ESTIMATED)
- Per-arm sample size summary: 350 total 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.
Arms
| Arm | Type | Dose | Frequency | Route | Description | N | Evidence status |
|---|---|---|---|---|---|---|---|
| Remibrutinib Cohort | NR | NR | NR | NR | Adult patients with CSU who are prescribed and initiating treatment with remibrutinib. | NR | Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer |
| Dupilumab Cohort | NR | NR | NR | NR | Adult patients with CSU who are prescribed and initiating treatment with dupilumab. | NR | Summary-level arm-size evidence exists, but exact N is not mapped to this CT.gov arm label in the current local layer |
Key source-backed points
- CT.gov identifies this as RELIEF, a real-world study in patients initiating remibrutinib or dupilumab.
- The primary outcome is change from baseline in UCT-7 at week 4.
Endpoints
- Primary outcomes:
- Change From Baseline in Urticaria Control Test - 7 Day Recall (UCT-7) Score at Week 4 in Patients Initiating Remibrutinib (time frame: Baseline and Week 4)
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: No trial-level primary publication is explicitly linked in the current registry.
Safety Findings
- Safety detail is not strongly enriched beyond the current CT.gov/source-registry layer.
Linked Evidence
- CT.gov page: https://clinicaltrials.gov/study/NCT07408219
- Local CT.gov cache:
raw/clinicaltrials/markdown/NCT07408219.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 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.
Provenance
- Source type: ClinicalTrials.gov inventory with linked sponsor/publication registry where available
- Primary source(s):
- NCT07408219
../raw/clinicaltrials/markdown/NCT07408219.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.