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A randomized, double blind, placebo controlled, Proof of Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab in participants with inadequately controlled chronic rhinosinusitis without nasal polyps

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515576-12-00
Acronym
ACT18421
Enrollment
53
Registered
2025-02-11
Start date
2025-03-20
Completion date
Unknown
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory tract diseases

Brief summary

Change from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan

Detailed description

Change from baseline in the sTSS, Change from baseline in nasal congestion (NC) severity score, Anterior/posterior rhinorrhea severity score, Facial pain/pressure severity score, and Loss of smell severity score using the CRSsNP daily e diary, Change from baseline in SNOT­22 total score, Change from baseline in sinus opacification as measured by the Lund-Mackay (LMK) score and the modified LMK score, Incidence of (treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment emergent serious adverse events (TESAEs), and treatment-emergent adverse events (TEAEs) leading to intervention discontinuation, Itepekimab concentration in serum, Incidence of treatment-emergent (TE) anti-itepekimab antibodies responses

Interventions

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan

Secondary

MeasureTime frame
Change from baseline in the sTSS, Change from baseline in nasal congestion (NC) severity score, Anterior/posterior rhinorrhea severity score, Facial pain/pressure severity score, and Loss of smell severity score using the CRSsNP daily e diary, Change from baseline in SNOT­22 total score, Change from baseline in sinus opacification as measured by the Lund-Mackay (LMK) score and the modified LMK score, Incidence of (treatment-emergent adverse events (TEAEs), treatment-emergent adverse events of special interest (TEAESIs), treatment emergent serious adverse events (TESAEs), and treatment-emergent adverse events (TEAEs) leading to intervention discontinuation, Itepekimab concentration in serum, Incidence of treatment-emergent (TE) anti-itepekimab antibodies responses

Countries

Belgium, France, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026