A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps
Public ClinicalTrials.gov record NCT06691113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older. Study details include: * The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks. * The intervention duration will be 24 weeks. * The number of visits will be 7 site visits and 8 phone/remote visits.
Study identification
- NCT ID
- NCT06691113
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 66 participants
Conditions and interventions
Conditions
Interventions
- Itepekimab (SAR440340) Drug
- Placebo Drug
- Mometasone furoate nasal spray (MFNS) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2024
- Primary completion
- Mar 30, 2026
- Completion
- Aug 11, 2026
- Last update posted
- Aug 24, 2026
2024 – 2026
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allervie Clinical Research - Birmingham- Site Number : 8400006 | Birmingham | Alabama | 35209 | — |
| Modena Allergy + Asthma- Site Number : 8400005 | La Jolla | California | 92037 | — |
| United Medical Doctors - Murrieta- Site Number : 8400001 | Murrieta | California | 92563 | — |
| Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008 | Roseville | California | 95661 | — |
| Western States Clinical Research- Site Number : 8400009 | Wheat Ridge | Colorado | 80033 | — |
| Advanced Research Associates (ARA) Professionals- Site Number : 8400002 | Miami | Florida | 33176 | — |
| Treasure Valley Medical Research- Site Number : 8400022 | Boise | Idaho | 83706 | — |
| ENT Associates of Texas - McKinne- Site Number : 8400013 | McKinney | Texas | 75070 | — |
| Alamo ENT Associates- Site Number : 8400026 | San Antonio | Texas | 78258 | — |
| Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400007 | Norfolk | Virginia | 23510 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06691113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2026 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06691113 live on ClinicalTrials.gov.