ACT18207
Research type
Research Study
Full title
A randomized Phase 2, double-blind, placebo-controlled, parallel-group, 2-arm study to assess the efficacy, safety, and tolerability of subcutaneous lunsekimig in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP)
IRAS ID
1009991
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2024-511261-11
Research summary
The purpose of this study is to determine how effective lunsekimig is in reducing the signs and symptoms of chronic rhinosinusitis with nasal polyps. Current medicines for chronic rhinosinusitis with nasal polyps (CRSwNP) aim to reduce swelling and symptoms, treatments usually include steroid nasal sprays and steroid pills. However, many people continue to have symptoms that interfere with their daily lives and better medicines are needed.
Nasal polyps are abnormal lumps inside the nose, these can develop in people who have long-term swelling of the nose and sinuses, called “chronic rhinosinusitis”.This study is a double-blind, placebo-controlled, 2-arm study lasting 40 weeks. The study compares how effective and safe the study medicine is compared to a placebo (dummy medicine). “Double-blind” means the participant nor the study doctors know who is given study medicine or placebo. This is done to make sure that the study results are not influenced in any way.
The study has three study periods: Screening (4 weeks) to assess suitability to start the study and ensure stable nasal steroid spray use, Treatment (24 weeks) and the after-Treatment period (12 weeks).
Lunsekimig has been shown to block certain inflammatory molecules that exist in the blood, nose, lungs, and other parts of the body that play a crucial role in CRSwNP and asthma.
Lunsekimig or placebo will be provided as a solution for injection under the skin. The treatment each participant will receive throughout the treatment period is randomly chosen at the beginning of this period, meaning it is determined by chance using a computer program.
The placebo looks like the medicine being tested, but it does not have any real medicine in it. That is why it is called a “dummy medicine”.
Participants 18 to 70 years of age with chronic rhinosinusitis with nasal polyps and continued symptoms.REC name
Wales REC 1
REC reference
24/WA/0127
Date of REC Opinion
17 Jun 2024
REC opinion
Further Information Favourable Opinion