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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06102005
Other study ID # DRI16762
Secondary ID U1111-1280-55142
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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