Amlitelimab

Phase 3Monoclonal antibody

Amlitelimab is one of 93 small molecule programs targeting Interstitial Lung Disease Due to Systemic Disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Interstitial Lung Disease Due to Systemic DiseaseRecruiting

Coeliac DiseaseActive, not recruiting

Atopic DermatitisCompleted

AsthmaCompleted

Dermatitis, AtopicCompleted

AMLActive, not recruiting

Interstitial Lung Disease Due to Systemic DiseasePhase 2

Recruiting

Coeliac DiseasePhase 2

Active, not recruiting

Atopic DermatitisPhase 3

Completed

AsthmaPhase 2

Completed

Dermatitis, AtopicPhase 3

Completed

AMLPhase 1

Active, not recruiting

Competition

Competitive Landscape

175 competitors in Asthma

#DrugCompanyPhaseTrials

Amlitelimab

Sanofi

Phase 3

2 2

Celexa

AbbVie

Preclinical

1 3

Arcoxia

Novartis

Preclinical

—4

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 5

DUPIXENT

Regeneron

Preclinical

1 6

Paracetamol

GSK

Preclinical

1 7

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 8

Aclidinium Bromide

AstraZeneca

Preclinical

—9

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 10

Lexapro

SShirley Ryan AbilityLab

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Interstitial Lung Disease Due to Systemic Disease

NCT06195072

Q1 2027

Phase 3Active, not recruiting

Dermatitis, Atopic

NCT06407934

Q3 2028

Phase 3Active, not recruiting

Dermatitis, Atopic

NCT06241118

Q1 2029

PreclinicalActive, not recruiting

Dermatitis, Atopic

NCT05492578

Clinical

Trials by Indication[1]

Dermatitis, Atopic7 trials

A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.

Active, not recruiting· Sanofi logo

Sanofi·Preclinical·NCT05492578·1,856 enrolled

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT06241118·464 enrolled

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Completed· Sanofi logo

Sanofi·Phase 3·NCT06181435·589 enrolled

Show 4 more trials

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

Completed· Sanofi logo

Sanofi·Phase 3·NCT06224348·643 enrolled

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses in Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· Sanofi logo

Sanofi·Phase 2·NCT06015308·224 enrolled

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Completed· Sanofi logo

Sanofi·Phase 3·NCT06130566·601 enrolled

A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT06407934·1,541 enrolled

Asthma2 trials

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT06033833·335 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 2·NCT05421598·446 enrolled

Atopic Dermatitis2 trials

Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

Completed·KKymab Limited·Phase 2·NCT05131477·390 enrolled

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT05769777·901 enrolled

Drug1 trial

A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants

Completed· Sanofi logo

Sanofi·Phase 1·NCT05796479·32 enrolled

Hidradenitis Suppurativa1 trial

Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Terminated· Sanofi logo

Sanofi·Phase 2·NCT06118099·90 enrolled

4 more indications

AML1 trial

An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates

Active, not recruiting· Sanofi logo

Sanofi·Phase 1·NCT06686628·23 enrolled

Coeliac Disease1 trial

A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Subcutaneous Amlitelimab in Adult Patients With Nonresponsive Celiac Disease as an Adjunct to a Gluten-free Diet

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT06557772·229 enrolled

Interstitial Lung Disease Due to Systemic Disease1 trial

Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants With Interstitial Lung Disease Secondary to Systemic Sclerosis

Recruiting·SScleroderma Research Foundation, Inc.·Phase 2·NCT06195072·400 enrolled

Alopecia Areata1 trial

A Phase 2, Randomized, Double-blind, Placebo--controlled, Parallel Group, 3-arm, Multinational, Multicenter, Proof-of-concept Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Adult Participants With Severe Alopecia Areata

Terminated· Sanofi logo

Sanofi·Phase 2·NCT06444451·166 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Amlitelimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Amlitelimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Amlitelimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Sanofi

Amlitelimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2028

Q1 2029

Trials by Indication[1]

Dermatitis, Atopic7 trials

Asthma2 trials

Atopic Dermatitis2 trials

Drug1 trial

Hidradenitis Suppurativa1 trial

AML1 trial

Coeliac Disease1 trial

Interstitial Lung Disease Due to Systemic Disease1 trial

Alopecia Areata1 trial

References

Drug Info

Quick Facts

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