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

Status: Completed
Location: See all (113) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: * The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. * The randomized treatment duration will be up to approximately 60 weeks. * The scheduled number of visits will be 13.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent.

• Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ).

• Participants on existing therapy with medium to high doses of ICS (≥500 μg fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist \[LABA\], leukotriene receptor antagonist \[LTRA\], long-acting muscarinic antagonist \[LAMA\], methylxanthines) for at least 3 months.

• ≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable).

• Participants with pre-BD forced expiratory volume in 1 second (FEV1) \> 40% and \< 80% of predicted normal at the screening visit.

• 5-item ACQ-5 score \>1.5 at randomization.

• Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test.

• Weight ≥40 kg and ≤150 kg at the randomization visit.

Locations
United States
California
University of California San Diego Health Site Number : 8400026
La Jolla
California Allergy and Asthma Medical Group, Inc. Site Number : 8400002
Los Angeles
Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019
San Jose
Bensch Clinical Research LLC Site Number : 8400004
Stockton
Allianz Research Institute Site Number : 8400023
Westminster
Florida
Helix Biomedics, LLC Site Number : 8400029
Boynton Beach
Renaissance Research and Medical Group, Inc Site Number : 8400030
Cape Coral
Beautiful Minds Clinical Research Center Site Number : 8400027
Cutler Bay
Reliable Clinical Research, LLC Site Number : 8400020
Hialeah
Savin Medical Group, LLC Site Number : 8400015
Miami
Pines Care Research Center LLC Site Number : 8400028
Pembroke Pines
Idaho
Treasure Valley Medical Research Site Number : 8400031
Boise
Indiana
The South Bend Clinic, LLC Site Number : 8400033
South Bend
Kansas
University of Kansas Medical Center Site Number : 8400016
Kansas City
Maryland
Johns Hopkins University School of Medicine Site Number : 8400012
Baltimore
Michigan
Headlands Research Detroit Site Number : 8400032
Southfield
Nevada
Henderson Clinical Trials Site Number : 8400037
Henderson
Ohio
Asthma and Allergy Center Site Number : 8400005
Toledo
Oklahoma
OK Clinical Research, LLC Site Number : 8400001
Edmond
Allergy, Asthma and Clinical Research Center Site Number : 8400035
Oklahoma City
Texas
TTS Research Site Number : 8400011
Boerne
Other Locations
Argentina
Investigational Site Number : 0320004
Buenos Aires
Investigational Site Number : 0320009
Buenos Aires
Investigational Site Number : 0320001
Caba
Investigational Site Number : 0320002
Caba
Investigational Site Number : 0320003
Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320008
La Plata
Investigational Site Number : 0320005
Rosario
Investigational Site Number : 0320006
Rosario
Investigational Site Number : 0320007
Rosario
Brazil
Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760010
Natal
Instituto Mederi de Pesquisa e Saude Site Number : 0760001
Passo Fundo
Hospital Sao Lucas da PUCRS Site Number : 0760006
Porto Alegre
Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760007
Porto Alegre
Proar Site Number : 0760004
Salvador
Hospital das Clinicas de Sao Paulo Site Number : 0760008
São Paulo
Clinica de Alergia Martti Antila Site Number : 0760003
Sorocaba
CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760002
Vitória
Canada
Investigational Site Number : 1240006
Brampton
Investigational Site Number : 1240008
Ottawa
Investigational Site Number : 1240003
Québec
Investigational Site Number : 1240005
Toronto
Investigational Site Number : 1240007
Trois-rivières
Chile
Investigational Site Number : 1520005
Quillota
Investigational Site Number : 1520001
Santiago
Investigational Site Number : 1520002
Santiago
Investigational Site Number : 1520003
Santiago
Investigational Site Number : 1520007
Santiago
Investigational Site Number : 1520008
Santiago
Investigational Site Number : 1520009
Santiago
Investigational Site Number : 1520006
Talca
Hungary
Investigational Site Number : 3480007
Budapest
Investigational Site Number : 3480009
Edelény
Investigational Site Number : 3480011
Gödöllö
Investigational Site Number : 3480002
Hajdunánás
Investigational Site Number : 3480004
Mosonmagyaróvár
Investigational Site Number : 3480006
Püspökladány
Investigational Site Number : 3480012
Százhalombatta
Investigational Site Number : 3480003
Szombathely
Italy
Investigational Site Number : 3800002
Cona (fe)
Investigational Site Number : 3800004
Napoli
Investigational Site Number : 3800003
Rome
Investigational Site Number : 3800001
Verona
Japan
Investigational Site Number : 3920004
Chuo-ku
Investigational Site Number : 3920005
Chuo-ku
Investigational Site Number : 3920017
Chuo-ku
Investigational Site Number : 3920008
Fukuoka
Investigational Site Number : 3920019
Hiroshima
Investigational Site Number : 3920002
Kamakura-shi
Investigational Site Number : 3920020
Kiyose-shi
Investigational Site Number : 3920015
Kumamoto
Investigational Site Number : 3920013
Nankoku-shi
Investigational Site Number : 3920014
Narita-shi
Investigational Site Number : 3920010
Sakai-shi
Investigational Site Number : 3920001
Shinagawa-ku
Investigational Site Number : 3920011
Shinjuku-ku
Investigational Site Number : 3920009
Tachikawa-shi
Investigational Site Number : 3920018
Toshima-ku
Investigational Site Number : 3920006
Yokohama
Investigational Site Number : 3920016
Yokohama
Mexico
Investigational Site Number : 4840002
Chihuahua City
Investigational Site Number : 4840004
Durango, Durango
Investigational Site Number : 4840001
Guadalajara
Investigational Site Number : 4840005
Guadalajara
Investigational Site Number : 4840006
Tlalnepantla
Investigational Site Number : 4840008
Yucatán
Poland
Investigational Site Number : 6160004
Bialystok
Investigational Site Number : 6160003
Elblag
Investigational Site Number : 6160002
Gdansk
Investigational Site Number : 6160006
Krakow
Investigational Site Number : 6160001
Poznan
Investigational Site Number : 6160007
Tarnów
Republic of Korea
Investigational Site Number : 4100004
Daegu
Investigational Site Number : 4100007
Seongnam-si, Gyeonggi-do
Investigational Site Number : 4100001
Seoul
Investigational Site Number : 4100002
Seoul
Investigational Site Number : 4100003
Seoul
Investigational Site Number : 4100005
Seoul
Investigational Site Number : 4100006
Seoul
South Africa
Investigational Site Number : 7100007
Benoni
Investigational Site Number : 7100001
Cape Town
Investigational Site Number : 7100002
Cape Town
Investigational Site Number : 7100005
Cape Town
Investigational Site Number : 7100003
Durban
Investigational Site Number : 7100006
George
Investigational Site Number : 7100008
Johannesburg
Investigational Site Number : 7100004
Middelburg
Turkey
Investigational Site Number : 7920001
Istanbul
Investigational Site Number : 7920003
Izmir
Investigational Site Number : 7920008
Kayseri
Investigational Site Number : 7920005
Kocaeli
Investigational Site Number : 7920002
Mersin
United Kingdom
Investigational Site Number : 8260001
Bradford
Time Frame
Start Date: 2022-06-30
Completion Date: 2025-03-20
Participants
Target number of participants: 446
Treatments
Experimental: Amlitelimab dose level 1
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 1 every 4 weeks (Q4W) until Week 20 (inclusive) and every 12 weeks (Q12W) starting from Week 24 and thereafter.
Experimental: Amlitelimab dose level 2
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 2 Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Experimental: Amlitelimab dose level 3
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 3 Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Placebo_comparator: Placebo
Initial loading dose of amlitelimab matching placebo on Day 1, followed by one injection of amlitelimab matching placebo Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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