Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
AIRLYMPUS
A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment
3 other identifiers
interventional
556
22 countries
230
Brief Summary
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments. Study details include:
- The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study.
- The investigational treatment duration will be up to approximately 52 weeks.
- The number of visits will be 18.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Nov 2024
Longer than P75 for phase_2 asthma
230 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2024
CompletedFirst Posted
Study publicly available on registry
November 6, 2024
CompletedStudy Start
First participant enrolled
November 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 19, 2027
July 1, 2026
June 1, 2026
2.6 years
November 4, 2024
June 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Annualized rate of asthma exacerbation events
Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma
From baseline up to 52 weeks
Secondary Outcomes (11)
Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)
From baseline to week 52
Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score
From baseline to week 52
Change from baseline in FeNO level
From baseline to week 52
Annualized rate of loss of asthma control events (LOAC) events
From baseline to week 52
Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit
From baseline to week 52
- +6 more secondary outcomes
Study Arms (2)
Lunsekimig
EXPERIMENTALParticipants will receive lunsekimig (SC injection) every 4 weeks
Placebo
PLACEBO COMPARATORParticipants will receive placebo (SC injection) every 4 weeks
Interventions
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation
Eligibility Criteria
You may qualify if:
- Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
- At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
- Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative \[GLI\] standards) at Screening (Visit 1).
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Other severe lung diseases (eg, chronic obstructive pulmonary disease \[COPD\]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
- 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 (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
- Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
- Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
- 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 TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
- 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.
- NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (230)
The Center for Clinical Trials - Saraland- Site Number : 8400096
Saraland, Alabama, 36571, United States
Chandler Clinical Research Trials- Site Number : 8400075
Chandler, Arizona, 85224, United States
Epic Medical Research - Sun City- Site Number : 8400052
Sun City, Arizona, 85351, United States
Tucson Clinical Research Institute- Site Number : 8400085
Tucson, Arizona, 85712, United States
Ark Clinical Research- Site Number : 8400097
Long Beach, California, 90815, United States
Downtown L.A. Research Center- Site Number : 8400080
Los Angeles, California, 90017, United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400061
North Hollywood, California, 91606, United States
Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062
San Mateo, California, 94403, United States
Stanford University Medical Center- Site Number : 8400108
Stanford, California, 94305, United States
Modena Allergy And Asthma- Site Number : 8400068
Torrance, California, 90505, United States
Howard University Hospital- Site Number : 8400107
Washington D.C., District of Columbia, 20060, United States
Helix Biomedics- Site Number : 8400005
Boynton Beach, Florida, 33435, United States
Beautiful Minds Clinical Research Center- Site Number : 8400019
Cutler Bay, Florida, 33157, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082
DeBary, Florida, 32713, United States
Alfa Medical Research- Site Number : 8400071
Hollywood, Florida, 33024, United States
Royal Clinical Trials - Inverness- Site Number : 8400067
Inverness, Florida, 34453, United States
Premier Medical Associates- Site Number : 8400077
Lady Lake, Florida, 32159, United States
D&H Pompano Research Center- Site Number : 8400072
Margate, Florida, 33063, United States
Research Institute of South Florida- Site Number : 8400023
Miami, Florida, 33173, United States
Innovations Biotech- Site Number : 8400044
Miami, Florida, 33186, United States
Tellabio International Research Services- Site Number : 8400083
Pembroke Pines, Florida, 33025, United States
Avanza Medical Research Center- Site Number : 8400056
Pensacola, Florida, 32503, United States
Hull and Hull Medical Specialists- Site Number : 8400079
Plantation, Florida, 33324, United States
Ilumina Medical Research- Site Number : 8400095
Saint Cloud, Florida, 34769, United States
Private Practice - Dr. David Kavtaradze- Site Number : 8400081
Cordele, Georgia, 31015, United States
EmVenio Research - Riverdale- Site Number : 8400109
Riverdale, Georgia, 30274, United States
Christie Clinic in Champaign on University- Site Number : 8400003
Champaign, Illinois, 61820, United States
University of Kansas Medical Center- Site Number : 8400105
Kansas City, Kansas, 66160, United States
Velocity Clinical Research - Rockville (formerly Meridian Clinical Research)- Site Number : 8400036
Rockville, Maryland, 20854, United States
Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042
Silver Spring, Maryland, 20901, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400014
Ann Arbor, Michigan, 48109, United States
Clarkston Medical Group- Site Number : 8400054
Clarkston, Michigan, 48346, United States
Javara - Mankato Clinic- Site Number : 8400001
Mankato, Minnesota, 56001, United States
Mayo Clinic in Rochester - Minnesota- Site Number : 8400057
Rochester, Minnesota, 55905, United States
Hannibal Regional Healthcare System- Site Number : 8400078
Hannibal, Missouri, 63401, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Doctors- Site Number : 8400069
New York, New York, 10011, United States
Pioneer Clinical Research - New York- Site Number : 8400092
New York, New York, 10016, United States
Piedmont Healthcare - Family Medicine- Site Number : 8400064
Statesville, North Carolina, 28625, United States
Cleveland Clinic - Cleveland- Site Number : 8400106
Cleveland, Ohio, 44195, United States
Asthma & Allergy Center - Toledo- Site Number : 8400020
Toledo, Ohio, 43617, United States
OK Clinical Research- Site Number : 8400060
Edmond, Oklahoma, 73034, United States
Clinical Research Associates of Central Pennsylvania- Site Number : 8400013
DuBois, Pennsylvania, 15801, United States
Thomas Jefferson University Hospital- Site Number : 8400110
Philadelphia, Pennsylvania, 19107, United States
Allergic Disease and Asthma Center (ADAC)- Site Number : 8400070
Greenville, South Carolina, 29607, United States
Orion Clinical Research
Austin, Texas, 78759, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400015
Boerne, Texas, 78006, United States
Epic Medical Research - De Soto- Site Number : 8400051
DeSoto, Texas, 75115, United States
Axsendo Clinical Research - Houston- Site Number : 8400065
Houston, Texas, 77058, United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400012
McKinney, Texas, 75069, United States
STAAMP Research - San Antonio- Site Number : 8400059
San Antonio, Texas, 78229, United States
Bandera Family Health Care - San Antonio- Site Number : 8400049
San Antonio, Texas, 78249, United States
Javara - San Marcos - Redwood Road- Site Number : 8400040
San Marcos, Texas, 78666, United States
Simcare Medical Research- Site Number : 8400102
Sugar Land, Texas, 77478, United States
Children's Wisconsin- Site Number : 8400073
Milwaukee, Wisconsin, 53226, United States
Investigational Site Number : 0320007
Berazategui, Buenos Aires, 1886, Argentina
Investigational Site Number : 0320011
La Plata, Buenos Aires, 1900, Argentina
Investigational Site Number : 0320013
Lobos, Buenos Aires, 7240, Argentina
Investigational Site Number : 0320006
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320010
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320016
Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Investigational Site Number : 0320005
Buenos Aires, 1121, Argentina
Investigational Site Number : 0320012
Buenos Aires, 1122, Argentina
Investigational Site Number : 0320002
Buenos Aires, 1414, Argentina
Investigational Site Number : 0320001
Buenos Aires, 1425, Argentina
Investigational Site Number : 0320004
Buenos Aires, 1425, Argentina
Investigational Site Number : 0320008
Corrientes, 3400, Argentina
Investigational Site Number : 0320014
Mendoza, 5500, Argentina
Investigational Site Number : 0320015
Mendoza, 5500, Argentina
Investigational Site Number : 0320009
Santa Fe, 3000, Argentina
Investigational Site Number : 0560003
Liège, 4000, Belgium
Investigational Site Number : 0560002
Mechelen, 2800, Belgium
Associacao Proar- Site Number : 0760002
Salvador, Estado de Bahia, 40060-330, Brazil
Universidade Federal de Goias- Site Number : 0760011
Goiânia, Goiás, 74605-020, Brazil
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760006
Curitiba, Paraná, 80060-900, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, 91010-006, Brazil
Incor - Instituto do Coracao- Site Number : 0760004
São Paulo, 05403-900, Brazil
Investigational Site Number : 1240011
Kelowna, British Columbia, V1Y 4N7, Canada
Investigational Site Number : 1240012
West Vancouver, British Columbia, V7T 2Z3, Canada
Investigational Site Number : 1240013
Ajax, Ontario, L1S 2J5, Canada
Investigational Site Number : 1240003
Guelph, Ontario, N1h 6j2, Canada
Investigational Site Number : 1240006
Stoney Creek, Ontario, L8G 2V6, Canada
Investigational Site Number : 1240008
Toronto, Ontario, M4G 3E8, Canada
Investigational Site Number : 1240014
Montreal, Quebec, H2X 3E4, Canada
Investigational Site Number : 1240002
Sherbrooke, Quebec, J1H 5N4, Canada
Investigational Site Number : 1520008
Concepción, Biobio, 4070094, Chile
Investigational Site Number : 1520002
Talca, Maule Region, 3465584, Chile
Investigational Site Number : 1520009
Lo Barnechea, Reg Metropolitana de Santiago, 7691236, Chile
Investigational Site Number : 1520010
Recoleta, Reg Metropolitana de Santiago, 8420000, Chile
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, 7500587, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7500692, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7500698, Chile
Investigational Site Number : 1520005
Quillota, Valparaiso, 2260877, Chile
Investigational Site Number : 1520004
Viña del Mar, Valparaiso, 2531172, Chile
Investigational Site Number : 1520007
Viña del Mar, Valparaiso, 2540364, Chile
Investigational Site Number : 1560027
Beijing, 100029, China
Investigational Site Number : 1560005
Changchun, 130021, China
Investigational Site Number : 1560021
Chengde, 067020, China
Investigational Site Number : 1560039
Chengdu, 611130, China
Investigational Site Number : 1560028
Foshan, 528399, China
Investigational Site Number : 1560010
Guangzhou, 510000, China
Investigational Site Number : 1560033
Guangzhou, 510180, China
Investigational Site Number : 1560037
Guiyang, 550002, China
Investigational Site Number : 1560042
Hangzhou, 310005, China
Investigational Site Number : 1560009
Hebei, 050051, China
Investigational Site Number : 1560040
Hefei, 230032, China
Investigational Site Number : 1560006
Hohhot, 010050, China
Investigational Site Number : 1560007
Hohhot, 010070, China
Investigational Site Number : 1560029
Huizhou, 516001, China
Investigational Site Number : 1560011
Huizhou, 516002, China
Investigational Site Number : 1560025
Jiazhuang, 050000, China
Investigational Site Number : 1560034
Jinan, 250001, China
Investigational Site Number : 1560038
Jinan, 250014, China
Investigational Site Number : 1560030
Lanzhou, 730000, China
Investigational Site Number : 1560018
Luoyang, 471003, China
Investigational Site Number : 1560003
Nanchang, 330006, China
Investigational Site Number : 1560014
Ningbo, 315010, China
Investigational Site Number : 1560001
Shanghai, 200080, China
Investigational Site Number : 1560043
Shanghai, 200433, China
Investigational Site Number : 1560016
Shenyang, 110004, China
Investigational Site Number : 1560019
Suzhou, 215002, China
Investigational Site Number : 1560008
Suzhou, 215006, China
Investigational Site Number : 1560017
Taiyuan, 030001, China
Investigational Site Number : 1560035
Taiyuan, 030032, China
Investigational Site Number : 1560002
Tianjin, 300121, China
Investigational Site Number : 1560013
Tianjin, 300211, China
Investigational Site Number : 1560022
Wuhan, 430030, China
Investigational Site Number : 1560036
Xi'an, 710004, China
Investigational Site Number : 1560032
Xi'an, 710061, China
Investigational Site Number : 1560044
Xianyang, 712000, China
Investigational Site Number : 1560012
Xuzhou, 221006, China
Investigational Site Number : 1560047
Yangzhou, 225000, China
Investigational Site Number : 1560023
Zhengzhou, 450003, China
Investigational Site Number : 1560026
Zhengzhou, 450007, China
Investigational Site Number : 1560045
Zigong, 643000, China
Investigational Site Number : 2080001
Hvidovre, 2650, Denmark
Investigational Site Number : 2080002
Vejle, 7100, Denmark
Investigational Site Number : 2500007
Amiens, 80000, France
Investigational Site Number : 2500004
Lyon, 69004, France
Investigational Site Number : 2500003
Montpellier, 34090, France
Investigational Site Number : 2500006
Paris, 75018, France
Investigational Site Number : 2500005
Pessac, 33604, France
Investigational Site Number : 2500001
Strasbourg, 67000, France
Investigational Site Number : 2500002
Toulouse, 31059, France
Investigational Site Number : 2760006
Ahrensburg, 22926, Germany
Investigational Site Number : 2760002
Bendorf, 56170, Germany
Investigational Site Number : 2760007
Berlin, 12159, Germany
Investigational Site Number : 6420001
Düsseldorf, 40225, Germany
Investigational Site Number : 2760004
Frankfurt, 60596, Germany
Investigational Site Number : 2760008
Frankfurt, 60596, Germany
Investigational Site Number : 2760003
Frankfurt am Main, 60389, Germany
Investigational Site Number : 2760001
Leipzig, 04347, Germany
Investigational Site Number : 2760005
Mainz, 55128, Germany
Investigational Site Number : 3480006
Debrecen, 4032, Hungary
Investigational Site Number : 3480002
Gödöllő, 2100, Hungary
Investigational Site Number : 3480003
Hajdúnánás, 4080, Hungary
Investigational Site Number : 3480004
Mosonmagyaróvár, 9200, Hungary
Investigational Site Number : 3480005
Pécs, 7635, Hungary
Investigational Site Number : 3480001
Püspökladány, 4150, Hungary
Investigational Site Number : 3760006
Haifa, 3436212, Israel
Investigational Site Number : 3760003
Jerusalem, 9103102, Israel
Investigational Site Number : 3760002
Jerusalem, 9112001, Israel
Investigational Site Number : 3760005
Petah Tikva, 4941492, Israel
Investigational Site Number : 3760001
Rehovot, 7610001, Israel
Investigational Site Number : 3760004
Tel Aviv, 6423906, Israel
Investigational Site Number : 3800008
Torette, Ancona, 60020, Italy
Investigational Site Number : 3800006
Monserrato, Cagliari, 09042, Italy
Investigational Site Number : 3800001
Cona, Ferrara, 44124, Italy
Investigational Site Number : 3800009
Genoa, Genova, 16132, Italy
Investigational Site Number : 3800004
Milan, Milano, 20122, Italy
Investigational Site Number : 3800003
Rozzano, Milano, 20089, Italy
Investigational Site Number : 3800010
Rome, Roma, 00168, Italy
Investigational Site Number : 3800012
Tradate (Va), Varese, 21049, Italy
Investigational Site Number : 3800007
Bergamo, 24127, Italy
Investigational Site Number : 3800005
Modena, 41125, Italy
Investigational Site Number : 3800013
Palermo, 90127, Italy
Investigational Site Number : 3800011
Reggio Emilia, 42100, Italy
Investigational Site Number : 3920002
Shinagawa, Tokyo, 142-8666, Japan
Investigational Site Number : 3920001
Ube, Yamaguchi, 755-8505, Japan
Investigational Site Number : 3920004
Tokyo, 162-8666, Japan
Investigational Site Number : 6160005
Poznan, Greater Poland Voivodeship, 60-309, Poland
Investigational Site Number : 6160001
Poznan, Greater Poland Voivodeship, 60-693, Poland
Investigational Site Number : 6160002
Bialystok, Podlaskie Voivodeship, 15-044, Poland
Investigational Site Number : 6160004
Chęciny, 26-060, Poland
Investigational Site Number : 6160009
Katowice, 40-600, Poland
Investigational Site Number : 6160003
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
Investigational Site Number : 6420002
Cluj-Napoca, 400006, Romania
Investigational Site Number : 7100004
Benoni, 1500, South Africa
Investigational Site Number : 7100005
Benoni, 1500, South Africa
Investigational Site Number : 7100002
Cape Town, 7530, South Africa
Investigational Site Number : 7100003
Durban, 3630, South Africa
Investigational Site Number : 7100006
Durban, 4001, South Africa
Investigational Site Number : 7100007
Johannesburg, 1821, South Africa
Investigational Site Number : 7240005
Santiago de Compostela, A Coruña [La Coruña], 15702, Spain
Investigational Site Number : 7240010
Badalona, Barcelona [Barcelona], 08916, Spain
Investigational Site Number : 7240009
Barcelona, Barcelona [Barcelona], 08017, Spain
Investigational Site Number : 7240015
Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7240017
Santander, Cantabria, 39008, Spain
Investigational Site Number : 7240016
Girona, Girona [Gerona], 17005, Spain
Investigational Site Number : 7240018
Benalmádena, Málaga, 29631, Spain
Investigational Site Number : 7240013
Madrid, 28003, Spain
Investigational Site Number : 7240008
Madrid, 28007, Spain
Investigational Site Number : 7240011
Madrid, 28010, Spain
Investigational Site Number : 7240002
Madrid, 28041, Spain
Investigational Site Number : 7240007
Madrid, 28046, Spain
Investigational Site Number : 7240004
Málaga, 29010, Spain
Investigational Site Number : 7240006
Málaga, 29010, Spain
Investigational Site Number : 7240001
Palma, 07120, Spain
Investigational Site Number : 7240014
Seville, 41012, Spain
Investigational Site Number : 7520003
Gothenburg, 413 45, Sweden
Investigational Site Number : 7520002
Lund, 221 85, Sweden
Investigational Site Number : 7520001
Solna, 171 64, Sweden
Investigational Site Number : 1580002
Hualien City, 970, Taiwan
Investigational Site Number : 1580005
Kaohsiung City, 807, Taiwan
Investigational Site Number : 1580006
Taichung, 404, Taiwan
Investigational Site Number : 1580007
Taichung, 407, Taiwan
Investigational Site Number : 1580004
Taipei, 100, Taiwan
Investigational Site Number : 1580003
Taipei, 110, Taiwan
Investigational Site Number : 1580001
Taoyuan City, 333, Taiwan
Investigational Site Number : 7920003
Kayseri, 38039, Turkey (Türkiye)
Investigational Site Number : 7920002
Kirikkale, 71100, Turkey (Türkiye)
Investigational Site Number : 7920001
Mersin, 33070, Turkey (Türkiye)
Investigational Site Number : 8260009
Ruislip, Hillingdon, HA4 8NX, United Kingdom
Investigational Site Number : 8260007
Corby, Northamptonshire, NN17 2UN, United Kingdom
Investigational Site Number : 8260006
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Investigational Site Number : 8260008
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Investigational Site Number : 8260005
Barnsley, S75 2EP, United Kingdom
Investigational Site Number : 8260003
Bradford, BD9 6RJ, United Kingdom
Investigational Site Number : 8260001
London, W1G 8HU, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2024
First Posted
November 6, 2024
Study Start
November 7, 2024
Primary Completion (Estimated)
June 21, 2027
Study Completion (Estimated)
July 19, 2027
Last Updated
July 1, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org