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

NCT05421598 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2026-03-30

Study results available
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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

Interventions

DRUG

Amlitelimab

Injection solution Subcutaneous injection

DRUG

Placebo

Injection solution Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-10-11
Completion
2025-03-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Poland
  • South Africa
  • South Korea
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05421598 on ClinicalTrials.gov