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

NCT06102005 | Completed Phase 2 FDA Drug

• 2 other identifiers: DRI16762U1111-1280-5514
• Study Type: interventional
• Target: 685
• Locations: 14 countries
• Sites: 156

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Annualized rate of asthma exacerbation events

  From baseline to week 48

Secondary Outcomes (18)

• Change from baseline in pre-bronchodilator (BD) FEV1

  From baseline to week 48

• Change from baseline in post-BD FEV1

  From baseline to week 48

• The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)

  From baseline to week 48

• Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score

  From baseline to week 48

• Change from baseline in ACQ-5 score

  From baseline to week 48

Study Arms (5)

Lunsekimig Dose1 interval 1

EXPERIMENTAL

Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1

Drug: Lunsekimig

Lunsekimig Dose 1 interval 2

EXPERIMENTAL

Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2

Drug: Lunsekimig

Lunsekimig Dose 2 interval 1

EXPERIMENTAL

Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1

Drug: Lunsekimig

Lunsekimig Dose 2 interval 2

EXPERIMENTAL

Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2

Drug: Lunsekimig

Placebo

PLACEBO COMPARATOR

Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2

Drug: Placebo

Interventions

Lunsekimig DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Lunsekimig Dose 1 interval 2; Lunsekimig Dose 2 interval 1; Lunsekimig Dose 2 interval 2; Lunsekimig Dose1 interval 1

Placebo DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (156)

Allergy, Asthma & Immunology Associates- Site Number : 8400009

Scottsdale, Arizona, 85251, United States

Location

Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072

Yuma, Arizona, 85364, United States

Location

Antelope Valley Clinical Trials- Site Number : 8400020

Lancaster, California, 93534, United States

Location

Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032

Northridge, California, 91324, United States

Location

Optimus Medical- Site Number : 8400046

San Francisco, California, 94102, United States

Location

Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038

San Jose, California, 95117, United States

Location

Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053

Thousand Oaks, California, 91360, United States

Location

Allianz Research Institute CO- Site Number : 8400026

Aurora, Colorado, 80014, United States

Location

Velocity Clinical Research - Denver- Site Number : 8400027

Englewood, Colorado, 80110, United States

Location

Western States Clinical Research- Site Number : 8400014

Wheat Ridge, Colorado, 80033, United States

Location

Beautiful Minds Clinical Research Center- Site Number : 8400049

Cutler Bay, Florida, 33157, United States

Location

Qway Research - Hialeah- Site Number : 8400015

Hialeah, Florida, 33010, United States

Location

Clintex Research Group - Miami - Coral Way- Site Number : 8400048

Miami, Florida, 33145, United States

Location

High Quality Research- Site Number : 8400039

Miami, Florida, 33184, United States

Location

Innovations Biotech- Site Number : 8400040

Miami, Florida, 33186, United States

Location

New Access Medical Center- Site Number : 8400043

Miami, Florida, 33186, United States

Location

Deluxe Health Center- Site Number : 8400045

Miami Lakes, Florida, 33014, United States

Location

Advanced Research Institute - New Port Richey- Site Number : 8400044

New Port Richey, Florida, 34653, United States

Location

Pines Care Research Center- Site Number : 8400057

Pembroke Pines, Florida, 33024, United States

Location

Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019

Sarasota, Florida, 34239, United States

Location

Appalachian Clinical Research- Site Number : 8400050

Calhoun, Georgia, 30701, United States

Location

PMG Research of Christie Clinic- Site Number : 8400066

Champaign, Illinois, 61822, United States

Location

Velocity Clinical Research Lafayette Site Number : 8400060

Lafayette, Louisiana, 70508, United States

Location

Javara - Privia Medical Group - Annapolis- Site Number : 8400033

Annapolis, Maryland, 21401, United States

Location

Brigham & Women's Hospital- Site Number : 8400034

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health System - Ann Arbor- Site Number : 8400004

Ann Arbor, Michigan, 48109, United States

Location

Javara - Mankato Clinic- Site Number : 8400051

Mankato, Minnesota, 56001, United States

Location

Midwest Clinical Research Center - St. Louis- Site Number : 8400006

St Louis, Missouri, 63141, United States

Location

Circuit Clinical - Middletown Medical - 111 Maltese Drive- Site Number : 8400065

Middletown, New York, 10940, United States

Location

Icahn School of Medicine at Mount Sinai- Site Number : 8400058

New York, New York, 10029, United States

Location

Carolina Clinical Research - Charlotte- Site Number : 8400071

Charlotte, North Carolina, 28273, United States

Location

Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029

Charlotte, North Carolina, 28287, United States

Location

Clinical Research Of Gastonia- Site Number : 8400013

Gastonia, North Carolina, 28054, United States

Location

Bernstein Clinical Research Center- Site Number : 8400016

Cincinnati, Ohio, 45231, United States

Location

Asthma & Allergy Center - Toledo- Site Number : 8400017

Toledo, Ohio, 43617, United States

Location

OK Clinical Research- Site Number : 8400021

Edmond, Oklahoma, 73034, United States

Location

Velocity Clinical Research - Medford- Site Number : 8400059

Medford, Oregon, 97504, United States

Location

Clinical Research Associates of Central PA - Dubois- Site Number : 8400069

DuBois, Pennsylvania, 15801, United States

Location

Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007

Pittsburgh, Pennsylvania, 15241, United States

Location

Circuit Clinical - PMSI Comprehensive Healthcare for Life - Pottstown - Medical Drive- Site Number : 8400064

Pottstown, Pennsylvania, 19464, United States

Location

VitaLink Research - Anderson - East Greenville- Site Number : 8400063

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research - Charleston- Site Number : 8400061

Charleston, South Carolina, 29414, United States

Location

Orion Clinical Research- Site Number : 8400001

Austin, Texas, 78759, United States

Location

South Texas Medical Research Institute - TTS Research- Site Number : 8400010

Boerne, Texas, 78006, United States

Location

Baylor University Medical Center- Site Number : 8400002

Dallas, Texas, 75246, United States

Location

Western Sky Medical Research- Site Number : 8400023

El Paso, Texas, 79903, United States

Location

Metroplex Pulmonary and Sleep Center- Site Number : 8400022

McKinney, Texas, 75069, United States

Location

VAST Clinical Research- Site Number : 8400062

Plano, Texas, 75093, United States

Location

Investigational Site Number : 0320007

Berazategui, Buenos Aires, 1886, Argentina

Location

Investigational Site Number : 0320003

La Plata, Buenos Aires, 1900, Argentina

Location

Investigational Site Number : 0320002

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320006

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320005

Buenos Aires, 1121, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, 1414, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 0320009

Mendoza, 5500, Argentina

Location

Investigational Site Number : 0320008

San Miguel de Tucumán, 4000, Argentina

Location

Investigational Site Number : 0320010

Santa Fe, 3000, Argentina

Location

Associacao Proar- Site Number : 0760003

Salvador, Estado de Bahia, 40060-330, Brazil

Location

Universidade Federal de Goias- Site Number : 0760007

Goiânia, Goiás, 74605-020, Brazil

Location

Centro de Estudos em Terapias Inovadoras- Site Number : 0760002

Curitiba, Paraná, 80030-110, Brazil

Location

Inst de Medicina Integral Professor Fernando Figueira- Site Number : 0760009

Recife, Pernambuco, 50070-550, Brazil

Location

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Dia do Pulmão- Site Number : 0760005

Blumenau, Santa Catarina, 89030-101, Brazil

Location

CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006

Rio de Janeiro, 22241-180, Brazil

Location

Incor - Instituto do Coracao- Site Number : 0760011

São Paulo, 05403-900, Brazil

Location

Investigational Site Number : 1240003

Hamilton, Ontario, L8N 4A6, Canada

Location

Investigational Site Number : 1240005

Stoney Creek, Ontario, L8G 2V6, Canada

Location

Investigational Site Number : 1240004

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Investigational Site Number : 1240001

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Investigational Site Number : 1520010

Valdivia, Los Ríos Region, 5110683, Chile

Location

Investigational Site Number : 1520001

Talca, Maule Region, 3465584, Chile

Location

Investigational Site Number : 1520006

Santiago, Reg Metropolitana de Santiago, 7500587, Chile

Location

Investigational Site Number : 1520005

Santiago, Reg Metropolitana de Santiago, 7500692, Chile

Location

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 7500698, Chile

Location

Investigational Site Number : 1520009

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7750495, Chile

Location

Investigational Site Number : 1520008

Quillota, Región de Valparaíso, 2260877, Chile

Location

Investigational Site Number : 1520011

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Investigational Site Number : 1560011

Beijing, 100144, China

Location

Investigational Site Number : 1560010

Changchun, 130021, China

Location

Investigational Site Number : 1560017

Changsha, 410015, China

Location

Investigational Site Number : 1560008

Chengdu, 610041, China

Location

Investigational Site Number : 1560001

Guangzhou, 510120, China

Location

Investigational Site Number : 1560009

Guangzhou, 510150, China

Location

Investigational Site Number : 1560006

Hefei, 230032, China

Location

Investigational Site Number : 1560014

Hohhot, 010050, China

Location

Investigational Site Number : 1560018

Mianyang, 621000, China

Location

Investigational Site Number : 1560007

Nanchang, 330006, China

Location

Investigational Site Number : 1560002

Pingxiang, 337055, China

Location

Investigational Site Number : 1560013

Shanghai, 200433, China

Location

Investigational Site Number : 1560015

Shenyang, 110004, China

Location

Investigational Site Number : 1560005

Wenzhou, 325027, China

Location

Investigational Site Number : 1560003

Wuhan, 430030, China

Location

Investigational Site Number : 1560004

Xuzhou, 221006, China

Location

Investigational Site Number : 1560016

Yangzhou, 225000, China

Location

Investigational Site Number : 1560012

Zhanjiang, 524004, China

Location

Investigational Site Number : 3560002

Coimbatore, 641028, India

Location

Investigational Site Number : 3560006

Delhi, 110 029, India

Location

Investigational Site Number : 3560009

Hyderabad, 500084, India

Location

Investigational Site Number : 3560008

Kanpur, 208002, India

Location

Investigational Site Number : 3560007

Kozhikode, 673008, India

Location

Investigational Site Number : 3560003

Lucknow, 226006, India

Location

Investigational Site Number : 3560001

Nagpur, 441203, India

Location

Investigational Site Number : 3560004

Pune, 411057, India

Location

Investigational Site Number : 3760006

Ashkelon, 7830604, Israel

Location

Investigational Site Number : 3760001

Haifa, 3104802, Israel

Location

Investigational Site Number : 3760008

Haifa, 3436212, Israel

Location

Investigational Site Number : 3760003

Jerusalem, 9103102, Israel

Location

Investigational Site Number : 3760002

Jerusalem, 9112001, Israel

Location

Investigational Site Number : 3760010

Petah Tikva, 4941492, Israel

Location

Investigational Site Number : 3760009

Ramat Gan, 5262100, Israel

Location

Investigational Site Number : 3760004

Rehovot, 7610001, Israel

Location

Investigational Site Number : 3760007

Tel Aviv, 6423906, Israel

Location

Investigational Site Number : 3920004

Kamogawa, Chiba, 296-0041, Japan

Location

Investigational Site Number : 3920002

Sakaidechō, Kagawa-ken, 762-8550, Japan

Location

Investigational Site Number : 3920010

Yokohama, Kanagawa, 231-0801, Japan

Location

Investigational Site Number : 3920011

Chūō, Tokyo, 104-0031, Japan

Location

Investigational Site Number : 3920005

Ube, Yamaguchi, 755-8505, Japan

Location

Investigational Site Number : 3920008

Fukushima, 960-1295, Japan

Location

Investigational Site Number : 3920003

Higashiōmi, 527-8505, Japan

Location

Investigational Site Number : 3920006

Kyoto, 610-0113, Japan

Location

Investigational Site Number : 3920009

Kyoto, 612-8555, Japan

Location

Investigational Site Number : 3920012

Miyazaki, 889-1692, Japan

Location

Investigational Site Number : 4840001

Guadalajara, Jalisco, 44100, Mexico

Location

Investigational Site Number : 4840004

Monterrey, Nuevo León, 66465, Mexico

Location

Investigational Site Number : 4840005

San Juan del Río, Querétaro, 76800, Mexico

Location

Investigational Site Number : 4840002

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840003

Durango, 34000, Mexico

Location

Investigational Site Number : 4840007

Mérida, 97070, Mexico

Location

Investigational Site Number : 4840008

Veracruz, 91910, Mexico

Location

Investigational Site Number : 7100004

Benoni, 1500, South Africa

Location

Investigational Site Number : 7100005

Benoni, 1500, South Africa

Location

Investigational Site Number : 7100003

Cape Town, 7530, South Africa

Location

Investigational Site Number : 7100002

Cape Town, 7700, South Africa

Location

Investigational Site Number : 7100001

Durban, 4001, South Africa

Location

Investigational Site Number : 7100006

Lochner ROAD, PRETORIA, South Africa

Location

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03722, South Korea

Location

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, 05030, South Korea

Location

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, 05505, South Korea

Location

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, 08308, South Korea

Location

Investigational Site Number : 4100005

Seoul, 06351, South Korea

Location

Investigational Site Number : 7920001

Akdeniz, 33070, Turkey (Türkiye)

Location

Investigational Site Number : 7920006

Bursa, 16059, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Istanbul, 34098, Turkey (Türkiye)

Location

Investigational Site Number : 7920003

Istanbul, 34854, Turkey (Türkiye)

Location

Investigational Site Number : 7920004

Izmir, 35110, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

İzmit, 41001, Turkey (Türkiye)

Location

Investigational Site Number : 7920007

Kayseri, 38039, Turkey (Türkiye)

Location

Investigational Site Number : 8260001

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

Investigational Site Number : 8260004

Glasgow, Edinburgh, City of, G12 0YN, United Kingdom

Location

Investigational Site Number : 8260005

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Investigational Site Number : 8260003

Birmingham, B15 2TH, United Kingdom

Location

Investigational Site Number : 8260008

Bradford, BD9 6RJ, United Kingdom

Location

Investigational Site Number : 8260009

Bristol, BS8 2RA, United Kingdom

Location

Related Links

• DRI16762 Plain Language Results Summary

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinial Science & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: October 16, 2023
• Primary Completion: February 23, 2026
• Study Completion: March 11, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

ZA (6); CN (18); IN (8); KR (6); TU (7); BR (8); CL (9); IL (9); JP (10); US (48); CA (4); AR (10); GB (6); ME (7)