Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

NCT05421598 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: DRI17509U1111-1272-26122024-510641-332022-000065-41
• Study Type: interventional
• Target: 437
• Locations: 14 countries
• Sites: 113

Brief Summary

This was a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study was 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) was 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 was up to approximately 60 weeks.
• The scheduled number of visits was 13.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks

  Severe asthma exacerbation event was defined as worsening of asthma requiring the use of systemic corticosteroids for \>=3 days or, in the case of a stable maintenance regimen of oral corticosteroids (OCS) for the treatment of asthma, a doubling of the dose for 3 or more days, or hospitalization or emergency room visit because of asthma requiring systemic corticosteroids. Annualized rate was the total number of severe asthma exacerbation events divided by the total observation duration and was estimated based on negative binomial regression.

  Baseline (Day 1) to Week 48

Secondary Outcomes (24)

• Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Week 48

  Baseline (Day 1) and Week 48

• Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 48

  Baseline (Day 1) and Week 48

• Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities [AQLQ(S)] Self-administered Score at Week 48

  Baseline (Day 1) and Week 48

• Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second at Week 48

  Baseline (Day 1) and Week 48

• Change From Baseline in Pre-Bronchodilator and Post-Bronchodilator Percent Predicted Forced Expiratory Volume in One Second at Week 48

  Baseline (Day 1) and Week 48

Study Arms (4)

Amlitelimab 62.5 mg With 125 mg Loading Dose

EXPERIMENTAL

Participants received amlitelimab SC injection at an initial loading dose of 125 mg on Day 1 followed by amlitelimab 62.5 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48.

Drug: Amlitelimab

Amlitelimab 125 mg With 250 mg Loading Dose

EXPERIMENTAL

Participants received amlitelimab SC injection at an initial loading dose of 250 mg on Day 1 followed by amlitelimab 125 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48.

Drug: Amlitelimab

Amlitelimab 250 mg With 500 mg Loading Dose

EXPERIMENTAL

Participants received amlitelimab SC injection at an initial loading dose of 500 mg on Day 1 followed by amlitelimab 250 mg SC injection Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48.

Drug: Amlitelimab

Placebo

PLACEBO COMPARATOR

Participants received amlitelimab matching placebo SC injection on Day 1 followed by Q4W until Week 20 (inclusive) and Q12W starting from Week 24 until Week 48.

Drug: Placebo

Interventions

Amlitelimab DRUG

Injection solution Subcutaneous injection

Also known as: SAR445229

Amlitelimab 125 mg With 250 mg Loading Dose; Amlitelimab 250 mg With 500 mg Loading Dose; Amlitelimab 62.5 mg With 125 mg Loading Dose

Placebo DRUG

Injection solution Subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Participants were excluded from the study if any of the following criteria apply:
• Chronic lung disease other than asthma.
• Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of \>10 pack-years.
• Participants who experienced a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening.
• Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
• Active infection or history of clinically significant infection
• 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.
• Active or latent tuberculosis (TB)
• A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured \>3 years prior to baseline).
• History of solid organ transplant.
• Hepatitis B, C or HIV.
• Pregnant or breastfeeding.
• History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
• Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab.
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (113)

University of California San Diego Health Site Number : 8400026

La Jolla, California, 92093-0990, United States

Location

California Allergy and Asthma Medical Group, Inc. Site Number : 8400002

Los Angeles, California, 90025, United States

Location

Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019

San Jose, California, 95117, United States

Location

Bensch Clinical Research LLC Site Number : 8400004

Stockton, California, 95207, United States

Location

Allianz Research Institute Site Number : 8400023

Westminster, California, 92683, United States

Location

Helix Biomedics, LLC Site Number : 8400029

Boynton Beach, Florida, 33435, United States

Location

Renaissance Research and Medical Group, Inc Site Number : 8400030

Cape Coral, Florida, 33991, United States

Location

Beautiful Minds Clinical Research Center Site Number : 8400027

Cutler Bay, Florida, 33157, United States

Location

Reliable Clinical Research, LLC Site Number : 8400020

Hialeah, Florida, 33012-5853, United States

Location

Savin Medical Group, LLC Site Number : 8400015

Miami, Florida, 33126, United States

Location

Pines Care Research Center LLC Site Number : 8400028

Pembroke Pines, Florida, 33023, United States

Location

Treasure Valley Medical Research Site Number : 8400031

Boise, Idaho, 83706, United States

Location

The South Bend Clinic, LLC Site Number : 8400033

South Bend, Indiana, 46617, United States

Location

University of Kansas Medical Center Site Number : 8400016

Kansas City, Kansas, 66103, United States

Location

Johns Hopkins University School of Medicine Site Number : 8400012

Baltimore, Maryland, 21224, United States

Location

Headlands Research Detroit Site Number : 8400032

Southfield, Michigan, 48034, United States

Location

Henderson Clinical Trials Site Number : 8400037

Henderson, Nevada, 89052, United States

Location

Asthma and Allergy Center Site Number : 8400005

Toledo, Ohio, 43617, United States

Location

OK Clinical Research, LLC Site Number : 8400001

Edmond, Oklahoma, 73034, United States

Location

Allergy, Asthma and Clinical Research Center Site Number : 8400035

Oklahoma City, Oklahoma, 73120, United States

Location

TTS Research Site Number : 8400011

Boerne, Texas, 78006, United States

Location

Investigational Site Number : 0320001

CABA, Buenos Aires, C1425BEN, Argentina

Location

Investigational Site Number : 0320002

CABA, Buenos Aires, C1425FVH, Argentina

Location

Investigational Site Number : 0320008

La Plata, Buenos Aires, B1900BNN, Argentina

Location

Investigational Site Number : 0320009

Buenos Aires, Buenos Aires F.D., 1060, Argentina

Location

Investigational Site Number : 0320006

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320007

Rosario, Santa Fe Province, S2000DEJ, Argentina

Location

Investigational Site Number : 0320005

Rosario, Santa Fe Province, S2000JKR, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, C1121ABE, Argentina

Location

Investigational Site Number : 0320003

Ciudad Autonoma Buenos Aires, C1414AIF, Argentina

Location

CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760002

Vitória, Espírito Santo, 29055 450, Brazil

Location

Proar Site Number : 0760004

Salvador, Estado de Bahia, 40060-330, Brazil

Location

Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760010

Natal, Rio Grande do Norte, 59062-000, Brazil

Location

Instituto Mederi de Pesquisa e Saude Site Number : 0760001

Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760007

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Sao Lucas da PUCRS Site Number : 0760006

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

Location

Hospital das Clinicas de Sao Paulo Site Number : 0760008

São Paulo, São Paulo, 05403-000, Brazil

Location

Clinica de Alergia Martti Antila Site Number : 0760003

Sorocaba, São Paulo, 18040-425, Brazil

Location

Investigational Site Number : 1240006

Brampton, Ontario, L6T 0G1, Canada

Location

Investigational Site Number : 1240008

Ottawa, Ontario, K1H 1E4, Canada

Location

Investigational Site Number : 1240005

Toronto, Ontario, M5T 3A9, Canada

Location

Investigational Site Number : 1240007

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Investigational Site Number : 1240003

Québec, G1V 4G5, Canada

Location

Investigational Site Number : 1520006

Talca, Maule Region, Chile

Location

Investigational Site Number : 1520007

Santiago, Reg Metropolitana de Santiago, 7500010, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7500692, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7500698, Chile

Location

Investigational Site Number : 1520009

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520008

Santiago, Reg Metropolitana de Santiago, 8380465, Chile

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 8910131, Chile

Location

Investigational Site Number : 1520005

Quillota, Región de Valparaíso, 2260877, Chile

Location

Investigational Site Number : 3480007

Budapest, 1033, Hungary

Location

Investigational Site Number : 3480009

Edelény, 3780, Hungary

Location

Investigational Site Number : 3480011

Gödöllö, 2100, Hungary

Location

Investigational Site Number : 3480002

Hajdunánás, 4080, Hungary

Location

Investigational Site Number : 3480004

Mosonmagyaróvár, 9200, Hungary

Location

Investigational Site Number : 3480006

Püspökladány, 4150, Hungary

Location

Investigational Site Number : 3480012

Százhalombatta, 2440, Hungary

Location

Investigational Site Number : 3480003

Szombathely, 9700, Hungary

Location

Investigational Site Number : 3800002

Cona (FE), Emilia-Romagna, 44124, Italy

Location

Investigational Site Number : 3800003

Rome, Lazio, 00168, Italy

Location

Investigational Site Number : 3800004

Naples, 80131, Italy

Location

Investigational Site Number : 3800001

Verona, 37134, Italy

Location

Investigational Site Number : 3920014

Narita-shi, Chiba, 286-8520, Japan

Location

Investigational Site Number : 3920002

Kamakura-shi, Kanagawa, 247-0072, Japan

Location

Investigational Site Number : 3920016

Yokohama, Kanagawa, 223-0059, Japan

Location

Investigational Site Number : 3920006

Yokohama, Kanagawa, 245-8575, Japan

Location

Investigational Site Number : 3920013

Nankoku-shi, Kochi, 783-8509, Japan

Location

Investigational Site Number : 3920015

Kumamoto, Kumamoto, 860-8556, Japan

Location

Investigational Site Number : 3920010

Sakai-shi, Osaka, 591-8555, Japan

Location

Investigational Site Number : 3920017

Chuo-ku, Tokyo, 103-0022, Japan

Location

Investigational Site Number : 3920005

Chuo-ku, Tokyo, 103-0027, Japan

Location

Investigational Site Number : 3920004

Chuo-ku, Tokyo, 104-0031, Japan

Location

Investigational Site Number : 3920020

Kiyose-shi, Tokyo, 204-8585, Japan

Location

Investigational Site Number : 3920001

Shinagawa-ku, Tokyo, 140-8522, Japan

Location

Investigational Site Number : 3920011

Shinjuku-ku, Tokyo, 162-8655, Japan

Location

Investigational Site Number : 3920009

Tachikawa-shi, Tokyo, 190-0014, Japan

Location

Investigational Site Number : 3920018

Toshima-ku, Tokyo, 170-0003, Japan

Location

Investigational Site Number : 3920008

Fukuoka, 811-1394, Japan

Location

Investigational Site Number : 3920019

Hiroshima, 730-0013, Japan

Location

Investigational Site Number : 4840001

Guadalajara, Jalisco, 44100, Mexico

Location

Investigational Site Number : 4840005

Guadalajara, Jalisco, 44670, Mexico

Location

Investigational Site Number : 4840002

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 4840004

Durango, Durango, 34080, Mexico

Location

Investigational Site Number : 4840006

Tlalnepantla, 54055, Mexico

Location

Investigational Site Number : 4840008

Yucatán, 97070, Mexico

Location

Investigational Site Number : 6160001

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Investigational Site Number : 6160006

Krakow, Lesser Poland Voivodeship, 31-559, Poland

Location

Investigational Site Number : 6160004

Bialystok, Podlaskie Voivodeship, 15-044, Poland

Location

Investigational Site Number : 6160003

Elblag, 82-300, Poland

Location

Investigational Site Number : 6160002

Gdansk, 80344, Poland

Location

Investigational Site Number : 6160007

Tarnów, 33-100, Poland

Location

Investigational Site Number : 7100007

Benoni, 1501, South Africa

Location

Investigational Site Number : 7100002

Cape Town, 7530, South Africa

Location

Investigational Site Number : 7100005

Cape Town, 7530, South Africa

Location

Investigational Site Number : 7100001

Cape Town, 7937, South Africa

Location

Investigational Site Number : 7100003

Durban, 4071, South Africa

Location

Investigational Site Number : 7100006

George, 6530, South Africa

Location

Investigational Site Number : 7100008

Johannesburg, 1401, South Africa

Location

Investigational Site Number : 7100004

Middelburg, 1055, South Africa

Location

Investigational Site Number : 4100004

Daegu, Daegu, 42415, South Korea

Location

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, 03312, South Korea

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03722, South Korea

Location

Investigational Site Number : 4100005

Seoul, Seoul-teukbyeolsi, 05030, South Korea

Location

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 138-878, South Korea

Location

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, South Korea

Location

Investigational Site Number : 4100007

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Investigational Site Number : 7920001

Istanbul, 34303, Turkey (Türkiye)

Location

Investigational Site Number : 7920003

Izmir, 35100, Turkey (Türkiye)

Location

Investigational Site Number : 7920008

Kayseri, 38039, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

Kocaeli, 41100, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Mersin, 33070, Turkey (Türkiye)

Location

Investigational Site Number : 8260001

Bradford, BD9 6RJ, United Kingdom

Location

Related Links

• DRI17509 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

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 30, 2022
• Primary Completion: October 11, 2024
• Study Completion: March 20, 2025
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ZA (8); AR (9); CL (8); JP (17); HU (8); PL (6); KR (7); GB (1); BR (8); CA (5); ME (6); TU (5); IT (4); US (21)