A study to evaluate the efficacy and safety of lebrikizumab in participants with CRSwNP
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/LY3650150 in Adult Participants with Chronic Rhinosinusitis with Nasal Polyps on Background Intranasal Corticosteroids
IRAS ID
1009822
Contact name
Michael Wilkewitz
Contact email
Sponsor organisation
Eli Lilly and Company
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition caused by swollen spaces inside the
nose and the air-filled spaces in the head (sinuses). Nasal polyps are soft and noncancerous growths
inside of the nose or sinuses caused by swelling. People with CRSwNP often have thick mucus in their nose and sinuses, causing nasal congestion (including stuffy nose and a feeling of pain or pressure in the face), runny nose, mucus running down the back of the throat, and loss of smell. Available treatments such as corticosteroids (medicines to reduce swelling), antibodies (proteins made in lab: dupilumab, omalizumab, and mepolizumab) and nasal surgery provide relief for a short period of time. CRSwNP may reoccur after treatment. Therefore, there is a need to find other medicines for the treatment of CRSwNP.
Lebrikizumab is a new drug being developed for treating people with CRSwNP. Lebrikizumab is an antibody that blocks the action of a specific substance that can trigger the swelling involved in CRSwNP. It is not yet approved for treating CRSwNP. Researchers thought that lebrikizumab may help in reducing the symptoms of CRSwNP.
The main purpose of this study is to see how well lebrikizumab works in participants with CRSwNP compared to a placebo.
All participants will also receive a background treatment with intranasal mometasone furoate (a medicine to decrease swelling).
A total of 510 participants around the world will take part in this study. All participants will be assigned to 1 of the 3 treatment groups by a computer, and each group will have about 170 participants. Participants have a 67% chance of receiving lebrikizumab and a 33% chance of receiving placebo. This study will have the following 4 periods: screening, run-in, treatment and safety follow-up.REC name
Wales REC 2
REC reference
24/WA/0132
Date of REC Opinion
15 Jul 2024
REC opinion
Further Information Favourable Opinion