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

Part of paid clinical trials in La Jolla, California.

Sponsor
Sanofi
Study ID
NCT05421598
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Amlitelimab — DRUG
    Injection solution Subcutaneous injection
  • Placebo — DRUG
    Injection solution Subcutaneous injection

Study Details

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.

Key Dates

Start date
Jun 30, 2022
Status verified
Feb 2026
Primary completion
Oct 11, 2024
Completion
Mar 20, 2025

Study Design

Enrollment
437 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amlitelimab 62.5 mg With 125 mg Loading Dose
    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.
  • Experimental: Amlitelimab 125 mg With 250 mg Loading Dose
    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.
  • Experimental: Amlitelimab 250 mg With 500 mg Loading Dose
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Annualized Rate of Severe Asthma Exacerbation Events Over 48 Weeks [ Time Frame: Baseline (Day 1) to Week 48 ]

Locations (21)

FacilityCityStateZIPSite coordinators
University of California San Diego Health Site Number : 8400026La JollaCalifornia92093-0990-
California Allergy and Asthma Medical Group, Inc. Site Number : 8400002Los AngelesCalifornia90025-
Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019San JoseCalifornia95117-
Bensch Clinical Research LLC Site Number : 8400004StocktonCalifornia95207-
Allianz Research Institute Site Number : 8400023WestminsterCalifornia92683-
Helix Biomedics, LLC Site Number : 8400029Boynton BeachFlorida33435-
Renaissance Research and Medical Group, Inc Site Number : 8400030Cape CoralFlorida33991-
Beautiful Minds Clinical Research Center Site Number : 8400027Cutler BayFlorida33157-
Reliable Clinical Research, LLC Site Number : 8400020HialeahFlorida33012-5853-
Savin Medical Group, LLC Site Number : 8400015MiamiFlorida33126-
Pines Care Research Center LLC Site Number : 8400028Pembroke PinesFlorida33023-
Treasure Valley Medical Research Site Number : 8400031BoiseIdaho83706-
The South Bend Clinic, LLC Site Number : 8400033South BendIndiana46617-
University of Kansas Medical Center Site Number : 8400016Kansas CityKansas66103-
Johns Hopkins University School of Medicine Site Number : 8400012BaltimoreMaryland21224-
Headlands Research Detroit Site Number : 8400032SouthfieldMichigan48034-
Henderson Clinical Trials Site Number : 8400037HendersonNevada89052-
Asthma and Allergy Center Site Number : 8400005ToledoOhio43617-
OK Clinical Research, LLC Site Number : 8400001EdmondOklahoma73034-
Allergy, Asthma and Clinical Research Center Site Number : 8400035Oklahoma CityOklahoma73120-
TTS Research Site Number : 8400011BoerneTexas78006-

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By research site
University of California San Diego Health· La Jolla, CACalifornia Allergy and Asthma Medical Group, Inc.· Los Angeles, CAAllergy Asthma Associates of Santa Clara Valley· San Jose, CABensch Clinical Research LLC· Stockton, CAAllianz Research Institute· Westminster, CAHelix Biomedics, LLC· Boynton Beach, FL

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