Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

Asthma Clinical Trial

— AIRCULES  

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102005
• Other study ID #: DRI16762
• Secondary ID: U1111-1280-55142
• Status: Recruiting
• Phase: Phase 2
• Start date: October 16, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US an
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• A physician-diagnosed moderate-to-severe asthma for =12 months based on GINA guidelines Steps 4 and 5

• Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose =1 month prior to Visit 1

• At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy

• ACQ-5 score more than 1.5 at Screening (Visit 1)

Exclusion Criteria:

• Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.

• Current smoker or former smoker with cessation within 6 months of Screening or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.

• Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening

• Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening

• For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).

• Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening

• Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease

• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Lunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
• Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320001	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320004	Ciudad Autonoma Buenos Aires
Argentina	Investigational Site Number : 0320009	Mendoza
Argentina	Investigational Site Number : 0320008	San Miguel de Tucuman
Brazil	HOSPITAL DIA DO PULMAO Site Number : 0760005	Blumenau	Santa Catarina
Brazil	CETI - Centro de Estudos em Terapias Inovadoras Site Number : 0760002	Curitiba	Paraná
Brazil	HC UFG - Hospital Das Clinicas de Goias Site Number : 0760007	Goiania	Goiás
Brazil	Instituto de Medicina Integral Prof Fernando Figueira Site Number : 0760009	Recife	Pernambuco
Brazil	Proar Site Number : 0760003	Salvador	Bahia
Chile	Investigational Site Number : 1520008	Quillota	Valparaíso
Chile	Investigational Site Number : 1520002	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520004	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520005	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520006	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520009	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520001	Talca	Maule
Chile	Investigational Site Number : 1520010	Valdivia	Los Ríos
Chile	Investigational Site Number : 1520011	Viña del Mar	Valparaíso
China	Investigational Site Number : 1560011	Beijing
China	Investigational Site Number : 1560010	Changchun
China	Investigational Site Number : 1560008	Chengdu
China	Investigational Site Number : 1560001	Guangzhou
China	Investigational Site Number : 1560014	Hohhot
China	Investigational Site Number : 1560007	Nanchang
China	Investigational Site Number : 1560002	Pingxiang
China	Investigational Site Number : 1560005	Wenzhou
China	Investigational Site Number : 1560004	Xuzhou
China	Investigational Site Number : 1560016	Yangzhou
India	Investigational Site Number : 3560002	Coimbatore
India	Investigational Site Number : 3560007	Kozhikode
India	Investigational Site Number : 3560003	Lucknow
India	Investigational Site Number : 3560001	Nagpur
India	Investigational Site Number : 3560004	Pune
Israel	Investigational Site Number : 3760001	Haifa
Israel	Investigational Site Number : 3760008	Haifa
Israel	Investigational Site Number : 3760002	Jerusalem
Israel	Investigational Site Number : 3760003	Jerusalem
Israel	Investigational Site Number : 3760009	Ramat Gan
Israel	Investigational Site Number : 3760004	Rehovot
Israel	Investigational Site Number : 3760007	Tel Aviv
Japan	Investigational Site Number : 3920011	Chuo-ku	Tokyo
Japan	Investigational Site Number : 3920008	Fukushima-shi	Fukushima
Japan	Investigational Site Number : 3920003	Higashiohmi-shi
Japan	Investigational Site Number : 3920006	Joyo-shi	Kyoto
Japan	Investigational Site Number : 3920004	Kamogawa-shi	Chiba
Japan	Investigational Site Number : 3920002	Sakaide-shi	Kagawa
Japan	Investigational Site Number : 3920005	Ube-shi	Yamaguchi
Japan	Investigational Site Number : 3920010	Yokohama-shi	Kanagawa
Korea, Republic of	Investigational Site Number : 4100001	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100002	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100003	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100004	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100005	Seoul
Korea, Republic of	Investigational Site Number : 4100006	Seoul	Seoul-teukbyeolsi
Turkey	Investigational Site Number : 7920006	Bursa
Turkey	Investigational Site Number : 7920002	Istanbul
Turkey	Investigational Site Number : 7920003	Istanbul
Turkey	Investigational Site Number : 7920007	Kayseri
Turkey	Investigational Site Number : 7920005	Kocaeli
Turkey	Investigational Site Number : 7920001	Mersin
United States	Appalachian Clinical Research Site Number : 8400050	Adairsville	Georgia
United States	Javara Inc Site Number : 8400033	Annapolis	Maryland
United States	Orion Clinical Research Site Number : 8400001	Austin	Texas
United States	TTS Research Site Number : 8400010	Boerne	Texas
United States	Brigham and Women's Hospital Site Number : 8400034	Boston	Massachusetts
United States	Tryon Medical Research Site Number : 8400029	Charlotte	North Carolina
United States	Beautiful Minds Clinical Research Center Site Number : 8400049	Cutler Bay	Florida
United States	Allianz Research Institute Colorado Site Number : 8400026	Denver	Colorado
United States	Velocity Clinical Research - Denver Site Number : 8400027	Denver	Colorado
United States	OK Clinical Research, LLC Site Number : 8400021	Edmond	Oklahoma
United States	Western Sky Medical Research Site Number : 8400023	El Paso	Texas
United States	Clinical Research of Gastonia Site Number : 8400013	Gastonia	North Carolina
United States	Qway Research LLC Site Number : 8400015	Hialeah	Florida
United States	Javara Inc/Mankato Clinic, Site Number : 8400051	Mankato	Minnesota
United States	Metroplex Pulmonary and Sleep Center Site Number : 8400022	McKinney	Texas
United States	Clintex Research Group Inc. Site Number : 8400048	Miami	Florida
United States	High Quality Research Site Number : 8400039	Miami	Florida
United States	Innovations Biotech Site Number : 8400040	Miami	Florida
United States	New Access Research & Medical Center Site Number : 8400043	Miami	Florida
United States	Deluxe Health Center Site Number : 8400045	Miami Lakes	Florida
United States	Advanced Research Institute, Inc. Site Number : 8400044	New Port Richey	Florida
United States	Amicis Research Center Site Number : 8400032	Northridge	California
United States	Pines Care Research Center LLC Site Number : 8400057	Pembroke Pines	Florida
United States	Allergy and Clinical Immunology Associates Site Number : 8400007	Pittsburgh	Pennsylvania
United States	Midwest Clinical Research LLC Site Number : 8400006	Saint Louis	Missouri
United States	Optimus Medical Group - San Francisco Site Number : 8400046	San Francisco	California
United States	Allergy & Asthma Associates of Santa Clara Valley Site Number : 8400038	San Jose	California
United States	Windom Allergy, Asthma & Sinus Site Number : 8400019	Sarasota	Florida
United States	Medical Research of Arizona Site Number : 8400009	Scottsdale	Arizona
United States	Western States Clinical Research Inc Site Number : 8400014	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  China,  India,  Israel,  Japan,  Korea, Republic of,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized rate of asthma exacerbation events		From baseline to week 48
Secondary	Change from baseline in pre-bronchodilator (BD) FEV1		From baseline to week 48
Secondary	Change from baseline in post-BD FEV1		From baseline to week 48
Secondary	The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)		From baseline to week 48
Secondary	Proportion of participants with = 0.5-point reduction in ACQ-5 score	ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control	From baseline to week 48
Secondary	Change from baseline in ACQ-5 score		From baseline to week 48
Secondary	Change from baseline in FeNO		From baseline to week 48
Secondary	Time to first asthma exacerbation		From baseline to week 48
Secondary	Annualized rate of loss of asthma control events (LOAC) events		From baseline to week 48
Secondary	Time to first LOAC event		From baseline to week 48
Secondary	Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit		From baseline to week 48
Secondary	Average number of inhalations per day of short-acting beta 2-agoinst (SABA) or Low dose ICS/formoterol for symptom relief		From baseline to week 48
Secondary	Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores	Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.	From baseline to week 48
Secondary	Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores		From baseline to week 48
Secondary	Change from baseline in ACQ scores		From baseline to week 48
Secondary	Serum lunsekimig concentrations		From baseline to week 48
Secondary	Anti-drug antibodies (ADA) against lunsekimig		From baseline to week 48
Secondary	Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)		From baseline to week 48