Clinical trial NCT06454240: A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.

The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.


Eligibility criteria: Inclusion Criteria:

- A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening

Ongoing symptoms for at least 2 months prior to screening, including:

* Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
* At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
* Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
* Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
* Active/chronic helminthic infection
* History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
* Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Primary outcomes:
measure: Change in bilateral endoscopic nasal polyp score (NPS).
timeFrame: From baseline to Week 24
Secondary outcomes:
measure: Change in patient-reported nasal congestion/obstruction score
timeFrame: From baseline to Week 24
measure: Change in Lund-Mackay CT score
timeFrame: From baseline to Week 24
measure: Change in the percent of maxillary sinus volume occupied by disease on CT scan.
timeFrame: From baseline to Week 24
measure: Change in SNOT-22 total score.
timeFrame: From baseline to Week 24
measure: Change in patient-reported total symptom score (nasal congestion/obstruction, anterior or posterior rhinorrhea, and loss of smell).
timeFrame: From baseline to Week 24
measure: Change in patient-reported anterior rhinorrhea and posterior rhinorrhea score
timeFrame: From baseline to Week 24
measure: Change in rhinosinusitis visual analog scale (VAS).
timeFrame: From baseline to Week 24
measure: Change in University of Pennsylvania Smell Identification Test (UPSIT) score.
timeFrame: From baseline to Week 24
measure: Change in patient-reported loss of smell score
timeFrame: From baseline to Week 24
measure: Serum lunsekimig concentrations
timeFrame: From baseline to end of study (approximately 36 weeks)
measure: Anti-drug antibodies (ADA) against lunsekimig
timeFrame: From baseline to end of study (approximately 36 weeks)
measure: Incidence of participants with treatment-emergent adverse events (TEAEs)
timeFrame: From baseline to end of study (approximately 36 weeks)
measure: Incidence of participants with adverse events of special interest (AESI)
timeFrame: From baseline to end of study (approximately 36 weeks)
measure: Incidence of participants with serious adverse events (SAEs)
timeFrame: From baseline to end of study (approximately 36 weeks)
measure: Change in asthma control questionnaire (ACQ-5)
timeFrame: From baseline to Week 24
measure: Change in pre-bronchodilator forced expiratory volume in the first second (pre-BD FEV1)
timeFrame: From baseline to Week 24
measure: Change in pre-BD percent predicted FEV1
timeFrame: From baseline to Week 24
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Modena Allergy + Asthma Site Number : 8400005
state: California
city: Roseville
country: United States
facility: Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003
state: California
city: San Diego
country: United States
facility: Senta Clinic- Site Number : 8400025
state: California
city: Tampa
country: United States
facility: James A Haley Veterans' Hospital- Site Number : 8400015
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown- Site Number : 8400012
state: Georgia
city: Boise
country: United States
facility: The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002
state: Idaho
city: Boston
country: United States
facility: Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016
state: Massachusetts
city: Tulsa
country: United States
facility: Essential Medical Research- Site Number : 8400020
state: Oklahoma
city: Dallas
country: United States
facility: Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center- Site Number : 8400017
state: Texas
city: McKinney
country: United States
facility: Berkson Medical Site Number : 8400014
state: Texas
city: San Antonio
country: United States
facility: Alamo ENT Associates Site Number : 8400001
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute - Odgen- Site Number : 8400022
state: Utah
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320002
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320003
city: Gent
country: Belgium
facility: Investigational Site Number : 0560002
city: Leuven
country: Belgium
facility: Investigational Site Number : 0560001
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000001
city: Krakow
country: Poland
facility: Investigational Site Number : 6160002
state: Malopolskie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160001
state: Mazowieckie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160003
state: Slaskie
city: Poznan
country: Poland
facility: Investigational Site Number : 6160004
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160007
city: Gloucester
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Gloucestershire
city: Manchester
country: United Kingdom
facility: Investigational Site Number : 8260003
city: Newcastle Upon Tyne
country: United Kingdom
facility: Investigational Site Number : 8260001
Study officials:
References: